<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03797365</url>
  </required_header>
  <id_info>
    <org_study_id>cpp17-065a/2016-A01651-50</org_study_id>
    <nct_id>NCT03797365</nct_id>
  </id_info>
  <brief_title>French Study to Evaluate the Impact of a Cognitive Therapy on Urinary Incontinent Women of All Age's Perineal Settings.</brief_title>
  <official_title>Randomized Trial to Evaluate the Impact of Cognitive Therapy Added to Normal Perineal Rehabilitation on Pelvic Floor Muscle Contraction for Urinary Incontinent Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre and Marie Curie University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>APHP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pierre and Marie Curie University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is a pathophysiological study evaluating the impact of a cognitive therapy on the&#xD;
      perineal neuromuscular mechanisms in women patients with urinary incontinence.&#xD;
&#xD;
      Some research works have been realized on the impact of a cognitive load test (CLT) on the&#xD;
      neuromuscular continence urinary mechanisms. It had been demonstrated that a CLT induced an&#xD;
      increase in the latency of voluntary perineal contraction. It had also been demonstrated that&#xD;
      a CLT had an influence on the involuntary perineal contraction pre-activation. Most recently,&#xD;
      the impact of a cognitive therapy on the perineal neuromuscular mechanisms on healthy&#xD;
      participants had been evaluated. It demonstrated that a cognitive therapy inhibited the&#xD;
      impact of the CLT on the perineal neuromuscular mechanisms.&#xD;
&#xD;
      The present project is about the evaluation of the interest of a cognitive therapy on the&#xD;
      neuromuscular mechanisms in case of attentional test in a urinary incontinent women&#xD;
      population. It could conduce to new therapeutic leads for the management of urinary&#xD;
      incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives and results expected&#xD;
&#xD;
      Cognition seems to have an effect on the physiological mechanisms of urinary continence.&#xD;
      Urinary continence is, among others, the effect of a good coordination between detrusor's&#xD;
      contraction and pelvic floor muscles' contraction. A cognitive disturbance involves&#xD;
      coordination's disturbance. It has already been demonstrated that a double task&#xD;
      rehabilitation (between cognition and perineal muscles) could annihilate the effects induced&#xD;
      by a cognitive disturbance on the physiological neuromuscular mechanisms of the urinary&#xD;
      incontinence. The objective of this study is to evaluate the benefit of a double task&#xD;
      cognitive rehabilitation for the patients with urinary incontinence (UI).&#xD;
&#xD;
      Current knowledge situation&#xD;
&#xD;
      Pelvic floor muscles have a major incidence for the physiological urinary continence. Even if&#xD;
      the external anal sphincter (EAS)'s muscles are not directly involved in urinary&#xD;
      incontinence, many studies have shown they had a synergistic contraction with levator ani&#xD;
      muscles during the voluntary and involuntary perineal contraction . Because they are easily&#xD;
      reachable for an electromyographic (EMG) recording, many authors have registered these&#xD;
      muscles in order to investigate the physiologic urinary continence. Amarenco et al. had shown&#xD;
      that pelvic floor muscles' intensity of contraction in response to a cough fit was&#xD;
      proportional to the cough intensity in an healthy volunteers population. This correlation was&#xD;
      beyond bladder's filling. For the patients with UI, Deffieux et al. shown a loss of&#xD;
      correlation between cough intensity and perineal contraction. Deffieux et al. also analyzed&#xD;
      the temporal sequence of muscle activation for the EAS during a cough fit. A perineal pre&#xD;
      contraction in an healthy volunteers population was observed. EAS's muscles EMG activation&#xD;
      began 210 ms (median) before external intercostal (EIC) muscles. This EAS's muscles&#xD;
      anticipation of contraction was not found in the group of patients with UI. The observation&#xD;
      that fewer patients were activating their AES's muscles, more the modulation of EAS's muscles&#xD;
      contraction was distorted when coughing was made. Thubert et al. observed that the perineal&#xD;
      contraction's latency was multiplied by 4 in case of cognitive load test (CLT) in an healthy&#xD;
      volunteers population. CLT leads to an EAS's muscles pre activation in case of coughing&#xD;
      effort, was also observed. A lowing of 29% of AES's muscles pre activation has been&#xD;
      demonstrated. These results suggest that cognition is involved in urinary continence's&#xD;
      physiological mechanisms. So it seamed to be interesting to study the impact of a double task&#xD;
      rehabilitation (cognitive and muscular) on the urinary continence's neuromuscular mechanisms&#xD;
      in case of diversion of attention. It was a randomized trial including two groups of healthy&#xD;
      volunteers: one group had double task rehabilitation during 15 days, the other had no&#xD;
      rehabilitation. After 15 days rehabilitation, in the rehabilitation's group, the attention&#xD;
      deficit's correction restored the resistive abilities of UI in case of attention hijacking.&#xD;
&#xD;
      According to the last AFU's (Association Française d'Urologie - Urology French Association)&#xD;
      and CNGOF's (Collège national des gynécologues et obstétriciens français - French&#xD;
      Gynecologists and Obstetricians National College) recommendations, the first intention&#xD;
      treatment of urinary incontinence is pelvi-perineal rehabilitation. Pelvi-perineal&#xD;
      rehabilitation conducted by a therapist is multimodal with different facets: a cognitive part&#xD;
      (education, pelvic floor realization), a behavioral part of bladder training (modification of&#xD;
      micturition habits), a muscle building part (voluntary contractions against resistance with&#xD;
      and without biofeedback and electrosimulation), and also a postural work part (balance and&#xD;
      pelvis position). Perineal rehabilitation technics' heterogeneity and the lack of description&#xD;
      of these technics let the professionals adapt their rehabilitation's protocols. The objective&#xD;
      of this study is to compare the results of two rehabilitation's technics in urinary&#xD;
      incontinent patients.&#xD;
&#xD;
      Methodology, study population, previous studies and feasibility&#xD;
&#xD;
      Study population: The population is made of voluntary incontinent women. Inclusion criteria&#xD;
      are the followings: Major women with stress urinary incontinence or mixed urinary&#xD;
      incontinence or urge urinary incontinence, in need to benefit from perineal rehabilitation or&#xD;
      cognitive-behavioral rehabilitation, women able to read, understand, accept and sign the&#xD;
      consent. Exclusion criteria are the following: pregnant women, refusal to participate,&#xD;
      dementia and cognitive troubles (Mini Mental State score: MMS &lt;30). Participants will be&#xD;
      subjects to a medical statement (antecedents, age, weight, size, UDI6 (Urogenital Distress&#xD;
      Inventory) questioner, Contilife and Wexner scores). The absence of a mental deficit will be&#xD;
      verifies by Mini Mental Status questioner (MMS).&#xD;
&#xD;
      Ethical considerations: A &quot;CPP&quot; (comité de protection des personnes - persons' protection&#xD;
      comity) have been requested and obtained for this study (N° cpp17-065a/2016-A01651-50). An&#xD;
      information letter will be delivered to the volunteers, who will be included only after the&#xD;
      acceptation and signature of the written consent.&#xD;
&#xD;
      Volunteers' randomization: Participants will be randomized in two groups (1/1) with data&#xD;
      processing software at the first visit at the therapist practicing the perineal&#xD;
      rehabilitation. The first group will receive &quot;Classical&quot; perineal rehabilitation for duration&#xD;
      of height weeks. The second group will receive perineal rehabilitation associated with a&#xD;
      double task cognitive therapy for a duration of height weeks. Participants will be evaluated&#xD;
      during the consultation.&#xD;
&#xD;
      Initial evaluation of volunteers: initial evaluation will consist of an interrogation able to&#xD;
      check the participants' antecedents and characteristics, urinary incontinence symptoms&#xD;
      (quality life score (Contilife) and severity score (International Consultation on&#xD;
      Incontinence Questionnaire Short Form: ICIQ-SF), Urinary Handicap Measurement (MHU - Mesure&#xD;
      du Handicap Urinaire) and also clinical examination (Pelvic Organ Prolaps Quantification:&#xD;
      POP-Q, Ulmsten Test, levator Testing among Oxford, ureteral mobility). In a second time, the&#xD;
      EMG analysis will be realized. It consists in the analysis of the CLT impact on the voluntary&#xD;
      and unvoluntary perineal contraction. The CLT used is Paced Auditory Serial addition Test&#xD;
      (PASAT). Test arrangements are the followings: The volunteer will listen to an audiotape on&#xD;
      witch is recorded a 61 random numbers set inconstant from 1 to 9 (for example &quot;1, 9, 4, 5…&quot;).&#xD;
      The volunteer patient will have to add each pair of number in order to add the number with&#xD;
      the previous and speak verbally the response. To test the willingly perineal contraction, the&#xD;
      volunteer will be in a sitting position with her arms on the armrests. The practitioner will&#xD;
      position the two electrodes with self-adhesive surface from either side of the volunteer's&#xD;
      anus regarding to the EAS muscle. These electrodes are usually used in a setting of classical&#xD;
      evaluation with biofeedback or electro simulation. An order will be given to the volunteer in&#xD;
      order to contract perineal muscles when she feels a stimulus on the left wrist (an electric&#xD;
      reflex hammer regarding to the median nerve on the inside of the left wrist). The volunteer&#xD;
      women will have to repeat the experience in two conditions: with and without the CLT.&#xD;
      Different settings measurement will be realized: time limit for the perineal contraction&#xD;
      reaction (RT), that is latency between stimulus and begins of AES's EMG activity increase.&#xD;
      The other settings will be the RT max (latency between stimulus and maximum AES's EMG&#xD;
      activity), maximum AES's EMG activity and air under the curve for the AES's EMG activity.&#xD;
      Volunteer's perineal contraction (following coughing instruction) will also be evaluated with&#xD;
      and without CLT. The coughing instruction will be ordered by an impulse (Reflex hammer) on&#xD;
      the inside of the left wrist. Two more self-adhesive detection electrodes will be glued&#xD;
      regarding the external intercostal muscles (7th right space). Principal data analyzed will&#xD;
      be: latency between stimulus and perineal muscles (RT1) and latency between intercostal&#xD;
      muscles and perineal muscles (RT3). The data set will be collected using a Biopac ®,&#xD;
      Acknowledge ®.&#xD;
&#xD;
      Classical perineal rehabilitation protocol&#xD;
&#xD;
      Participants will benefit from two-phases perineal rehabilitation: first phase pelvic floor&#xD;
      muscles (PFM)'s analytic rehabilitation, then a functional rehabilitation.&#xD;
&#xD;
      First phase will include the PFM's awareness and voluntary contraction learning with manual,&#xD;
      biofeedback technics and functional electro stimulation (FES). Then, therapist will propose&#xD;
      PFM's reinforcement under the PERFECT method (Pressure, Endurance, rapid Contraction, time&#xD;
      measurement between each contraction sequence). These exercises will call out the manual&#xD;
      rehabilitation technics (voluntary contraction learning, pelvic anatomy), biofeedback and&#xD;
      electro stimulation. Electro stimulation and biofeedback will necessit the use of an&#xD;
      electrode that serves to the electromyographic measurement with and without cognitive load&#xD;
      test. Each classical rehabilitation session will take 30 minutes with 20 minutes of active&#xD;
      working, twice per week. About the self-training, there will be no consensus for optimal&#xD;
      homemade exercises, neither on the number, nor on the duration. The different authors&#xD;
      describe very different types of protocols. The self-training program will be set up as soon&#xD;
      as the participant will be able to realize, under therapist's manual control, a voluntary&#xD;
      analytic contraction without synergy or command reversion. Exercises' number and&#xD;
      characteristic will be given according to the PERFECT Scheme.&#xD;
&#xD;
      For the second phase, the participant will hold a micturition calendar. With the noticed&#xD;
      elements, a behavior analyze will be summarized in order to update the favoring situations&#xD;
      and inappropriate situations. The objective will be the learning of perineal locking and&#xD;
      reinstatement of anticipative postural activity for stress urinary incontinence. The strategy&#xD;
      put in place will be organized in unlearning of deleterious perineal habits and learning new&#xD;
      behavior program. The functional training program will be made of activation of PFM's&#xD;
      voluntary contractions during different stains of every day life; the main goal being the&#xD;
      perineal locking set up (PFM's voluntary contraction associated with a good abdominal and&#xD;
      perineal synergy), this locking must be systematic before and during efforts like carrying&#xD;
      loads, trimming, coughing. During the second phase, the physiotherapist will twice weekly&#xD;
      perform evaluations. These evaluations are similar to those in the first phase.&#xD;
&#xD;
      Cognitive associated rehabilitation protocol: Added to the classic perineal muscular&#xD;
      rehabilitation, the cognitive associated rehabilitation group randomized participants will&#xD;
      have to execute twice a day the rehabilitation protocol. Each cognitive rehabilitation&#xD;
      session will take three minutes. Participants will have to synergistically execute&#xD;
      attentional tests (N-Back Test) and execute a perineal contraction during the contraction&#xD;
      instructions. (10 randomized auditory stimuli in three minutes). The attentional tests'&#xD;
      difficulty will be gradually increased each 15 days. N-Back Test modalities are the&#xD;
      followings: the participant will visualize a series of random numbers. First difficulty step&#xD;
      will be to click the dedicated button when the volunteer will see the indicated letter. The&#xD;
      second difficulty step will be to click the dedicated button when she will see two&#xD;
      consecutives times the same letter. The third difficulty step will be to click the dedicated&#xD;
      button when she will see two times the same letter separated by one different letter, and so&#xD;
      on… The data will be saved on the digital application.&#xD;
&#xD;
      Methodology: Participants will consult twice per week their therapist. An intermediary&#xD;
      clinical and EMG recording will be done in the fourth week to evaluate the evolution of&#xD;
      symptoms and EMG's criteria, with the same arrangements as those of the first evaluation.&#xD;
&#xD;
      Participants' final evaluation: During the last visit in the eighth week, participants will&#xD;
      be evaluated with same arrangements as those of the first evaluation.&#xD;
&#xD;
      Judgment criteria: About the involuntary perineal contraction study, the principal judgment&#xD;
      criteria will be the latency between intercostal muscles contraction and perineal muscles&#xD;
      contraction (RT3). Secondary judgment criteria will be: latency between stimulus and perineal&#xD;
      muscles contraction (RT1) for the voluntary perineal contraction study, MHU score obtained&#xD;
      (Mesure du Handicap Urinaire - urinary handicap score), ICIQ (International Consultation on&#xD;
      Incontinence Questionnaire), Contilife.&#xD;
&#xD;
      Statistic analysis:&#xD;
&#xD;
      Descriptive data will be expressed in the form of median and interquartile gap. The Wilcoxon&#xD;
      Test will be used to compare quantitative values before and after rehabilitation, and Student&#xD;
      Test to compare quantitative values between &quot;classical perineal rehabilitation&quot; group and&#xD;
      &quot;perineal rehabilitation + cognitive therapy&quot; group. According to the literature, middle RT3&#xD;
      is -60ms, expected difference after rehabilitation is 16,66ms and known standard deviation is&#xD;
      18,7ms. For an alpha risk 5% and power 80%, it is necessary to include 20 participants by&#xD;
      group, whether total of 40 participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 10, 2019</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study is a controlled randomized single blind multicentric study on a sample of 40 women stress or mixed urinary incontinent. Participants will be randomized in two groups with a 1/1 ratio with data processing software at the first visit at the therapist practicing the perineal rehabilitation. The first group will receive &quot;Classical&quot; perineal rehabilitation for duration of height weeks. The second group will receive perineal rehabilitation associated to a double task cognitive therapy for duration of height weeks. Participants will be evaluated during the consultation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>RT3 - EMG Latency between intercostal muscles contraction and perineal muscles contraction</measure>
    <time_frame>Final evaluation at the eighth week follow up</time_frame>
    <description>EMG Latency between intercostal muscles contraction and perineal muscles contraction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RT3 - EMG Latency between intercostal muscles contraction and perineal muscles</measure>
    <time_frame>Intermediary evaluation at the fourth week follow up</time_frame>
    <description>EMG Latency between intercostal muscles contraction and perineal muscles contraction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RT1 - EMG Latency between stimulus and perineal muscles contraction</measure>
    <time_frame>Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up</time_frame>
    <description>EMG Latency between stimulus and perineal muscles contraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Handicap Measurement (Mesure du Handicap Urinaire - MHU)</measure>
    <time_frame>Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up</time_frame>
    <description>Urinary Handicap Measurement is a quantitative measurement of different urinary symptoms, with 7 different questions, each response is associated to a value from 0 to 4, and with a final score from 0 (lowest score, no symptoms of urinary incontinence) to 28 (Higher score, maximum urinary incontinence symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Consultation on Incontinence Questionnaire (ICIQ-SF)</measure>
    <time_frame>Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up</time_frame>
    <description>The ICIQ SF is a subjective measurement of severity of urinary loss and quality of life for those with urinary incontinence. It has 4 main items (of 6 total) ask for rating of symptoms in the past 4 weeks. The actual score takes sum score of items 3+4+5 (items 1 and 2 are demographic). The final item (6) is self diagnostic item that is unscored.&#xD;
Final score is from 0 (lowest score, no symptoms of urinary incontinence), to 21 (Higher score, maximum urinary incontinence symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire for assessment of quality of life related to women urinary incontinence (Contilife)</measure>
    <time_frame>Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up</time_frame>
    <description>Auto survey of 28 questions for the quality of life related to the women with urinary incontinence. There are 6 main subjects related to quality of life, and each question has a score from 0 or 1 to 5. The final score is Final score is from 23 (lowest score, no impact of urinary incontinence on quality of life), to 140 (Higher score, maximum impact of urinary incontinence on quality of life).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Urinary Incontinence, Stress</condition>
  <condition>Urinary Incontinence, Urge</condition>
  <arm_group>
    <arm_group_label>Classical rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twenty women will benefit from two-phases perineal rehabilitation: first phase pelvic floor muscles (PFM)'s analytic rehabilitation, then a functional rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Classical and cognitive associated rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty women will receive, added to the classic perineal rehabilitation, the cognitive rehabilitation and will have to execute twice a day the rehabilitation protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Classical rehabilitation</intervention_name>
    <description>Participants will benefit from two-phases perineal rehabilitation:&#xD;
First phase will include the PFM's awareness and voluntary contraction learning with manual, biofeedback technics and functional electro stimulation. These exercises will call out the manual rehabilitation technics, biofeedback and electro stimulation. Each classical rehabilitation session will take 30 minutes with 20 minutes of active working, twice per week. About the self-training, there will be no consensus for optimal homemade exercises.&#xD;
For the second phase, a behavior analyze will be summarized in order to update the favoring and inappropriate situations. The strategy put in place will be organized in unlearning of deleterious perineal habits and learning new behavior program. The main goal will be the perineal locking set up, which must be systematic before and during efforts. During this phase, the physiotherapist will twice weekly perform evaluations (similar to those in the first phase)</description>
    <arm_group_label>Classical rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive associated rehabilitation</intervention_name>
    <description>The cognitive associated rehabilitation group randomized participants will have to execute twice a day the rehabilitation protocol. Each cognitive rehabilitation session will take three minutes. Participants will have to synergistically execute attentional tests (N-Back Test) and execute a perineal contraction during the contraction instructions. (10 randomized auditory stimuli in three minutes). The attentional tests' difficulty will be gradually increased each 15 days. N-Back Test modalities are the followings: the participant will visualize a series of random numbers. First difficulty step will be to click the dedicated button when the volunteer will see the indicated letter. The second difficulty step will be to click the dedicated button when she will see two consecutives times the same letter. The third difficulty step will be to click the dedicated button when she will see two times the same letter separated by one different letter, and so on…</description>
    <arm_group_label>Classical and cognitive associated rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major women with stress urinary incontinence or mixed urinary incontinence or urge&#xD;
             urinary incontinence, in need to benefit from perineal rehabilitation or&#xD;
             cognitive-behavioral rehabilitation&#xD;
&#xD;
          -  Women able to read, understand, accept and sign the consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women,&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Dementia and cognitive troubles (MMS&lt;30).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thibault THUBERT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Hotel Dieu Nantes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre-André MAL, resident</last_name>
    <role>Study Chair</role>
    <affiliation>CHU Hopital Tenon APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thibault THUBERT, MD</last_name>
    <phone>+33647697800</phone>
    <email>Thibault.thubert@chu-nantes.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pierre-André MAL, resident</last_name>
    <phone>+33659363500</phone>
    <email>malpierreandre@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8. doi: 10.1053/apmr.2001.24297.</citation>
    <PMID>11494188</PMID>
  </reference>
  <reference>
    <citation>Amarenco G, Ismael SS, Lagauche D, Raibaut P, Rene-Corail P, Wolff N, Thoumie P, Haab F. Cough anal reflex: strict relationship between intravesical pressure and pelvic floor muscle electromyographic activity during cough. Urodynamic and electrophysiological study. J Urol. 2005 Jan;173(1):149-52. doi: 10.1097/01.ju.0000147305.00443.df.</citation>
    <PMID>15592060</PMID>
  </reference>
  <reference>
    <citation>Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. External intercostal muscles and external anal sphincter electromyographic activity during coughing. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Apr;19(4):521-4. doi: 10.1007/s00192-007-0473-y. Epub 2007 Oct 13.</citation>
    <PMID>17934686</PMID>
  </reference>
  <reference>
    <citation>Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, Denys P, Dompeyre P, Faltin D, Fatton B, Haab F, Hermieux JF, Kerdraon J, Mares P, Mellier G, Michel-Laaengh N, Nadeau C, Robain G, de Tayrac R, Jacquetin B; French College of Gynaecologists and Obstetricians. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):14-9. doi: 10.1016/j.ejogrb.2010.02.041. Epub 2010 Mar 16.</citation>
    <PMID>20236751</PMID>
  </reference>
  <reference>
    <citation>Hermieu JF, Denys P, Fritel X. [Critical review of guidelines for female urinary incontinence diagnosis and treatment]. Prog Urol. 2012 Oct;22(11):636-43. doi: 10.1016/j.purol.2012.08.004. Epub 2012 Sep 10. French.</citation>
    <PMID>22999088</PMID>
  </reference>
  <reference>
    <citation>Klovning A, Avery K, Sandvik H, Hunskaar S. Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn. 2009;28(5):411-5. doi: 10.1002/nau.20674.</citation>
    <PMID>19214996</PMID>
  </reference>
  <reference>
    <citation>Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.</citation>
    <PMID>10813117</PMID>
  </reference>
  <reference>
    <citation>Horton AM Jr, Alana S. Validation of the Mini-Mental State Examination. Int J Neurosci. 1990 Aug;53(2-4):209-12. doi: 10.3109/00207459008986604.</citation>
    <PMID>2265941</PMID>
  </reference>
  <results_reference>
    <citation>Thubert T, Villot A, Billecocq S, Auclair L, Amarenco G, Deffieux X. Influence of a distraction task on the involuntary reflex contraction of the pelvic floor muscles following cough. Neurourol Urodyn. 2017 Jan;36(1):160-165. doi: 10.1002/nau.22903. Epub 2015 Oct 9.</citation>
    <PMID>26451967</PMID>
  </results_reference>
  <results_reference>
    <citation>Thubert T, Deffieux X, Jousse M, Guinet-Lacoste A, Ismael SS, Amarenco G. Influence of a distraction task on pelvic floor muscle contraction. Neurourol Urodyn. 2015 Feb;34(2):139-43. doi: 10.1002/nau.22524. Epub 2014 Feb 12.</citation>
    <PMID>24519688</PMID>
  </results_reference>
  <results_reference>
    <citation>Villot A, Deffieux X, Billecocq S, Auclair L, Amarenco G, Thubert T. Influence of cognitive rehabilitation on pelvic floor muscle contraction: A randomized controlled trial. Neurourol Urodyn. 2017 Aug;36(6):1636-1644. doi: 10.1002/nau.23169. Epub 2016 Oct 29.</citation>
    <PMID>27794195</PMID>
  </results_reference>
  <results_reference>
    <citation>Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8. doi: 10.1016/j.urology.2007.03.084.</citation>
    <PMID>17905093</PMID>
  </results_reference>
  <results_reference>
    <citation>Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Abnormal pelvic response to cough in women with stress urinary incontinence. Neurourol Urodyn. 2008;27(4):291-6. doi: 10.1002/nau.20506.</citation>
    <PMID>17803192</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pierre and Marie Curie University</investigator_affiliation>
    <investigator_full_name>Thubert Thibault</investigator_full_name>
    <investigator_title>Principal Investigator, Medical Doctor of Gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03797365
org study id: cpp17-065a/2016-A01651-50
nct id: NCT03797365
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is a pathophysiological study evaluating the impact of a cognitive therapy on the
      perineal neuromuscular mechanisms in women patients with urinary incontinence.

      Some research works have been realized on the impact of a cognitive load test (CLT) on the
      neuromuscular continence urinary mechanisms. It had been demonstrated that a CLT induced an
      increase in the latency of voluntary perineal contraction. It had also been demonstrated that
      a CLT had an influence on the involuntary perineal contraction pre-activation. Most recently,
      the impact of a cognitive therapy on the perineal neuromuscular mechanisms on healthy
      participants had been evaluated. It demonstrated that a cognitive therapy inhibited the
      impact of the CLT on the perineal neuromuscular mechanisms.

      The present project is about the evaluation of the interest of a cognitive therapy on the
      neuromuscular mechanisms in case of attentional test in a urinary incontinent women
      population. It could conduce to new therapeutic leads for the management of urinary
      incontinence.
Objectives and results expected

      Cognition seems to have an effect on the physiological mechanisms of urinary continence.
      Urinary continence is, among others, the effect of a good coordination between detrusor's
      contraction and pelvic floor muscles' contraction. A cognitive disturbance involves
      coordination's disturbance. It has already been demonstrated that a double task
      rehabilitation (between cognition and perineal muscles) could annihilate the effects induced
      by a cognitive disturbance on the physiological neuromuscular mechanisms of the urinary
      incontinence. The objective of this study is to evaluate the benefit of a double task
      cognitive rehabilitation for the patients with urinary incontinence (UI).

      Current knowledge situation

      Pelvic floor muscles have a major incidence for the physiological urinary continence. Even if
      the external anal sphincter (EAS)'s muscles are not directly involved in urinary
      incontinence, many studies have shown they had a synergistic contraction with levator ani
      muscles during the voluntary and involuntary perineal contraction . Because they are easily
      reachable for an electromyographic (EMG) recording, many authors have registered these
      muscles in order to investigate the physiologic urinary continence. Amarenco et al. had shown
      that pelvic floor muscles' intensity of contraction in response to a cough fit was
      proportional to the cough intensity in an healthy volunteers population. This correlation was
      beyond bladder's filling. For the patients with UI, Deffieux et al. shown a loss of
      correlation between cough intensity and perineal contraction. Deffieux et al. also analyzed
      the temporal sequence of muscle activation for the EAS during a cough fit. A perineal pre
      contraction in an healthy volunteers population was observed. EAS's muscles EMG activation
      began 210 ms (median) before external intercostal (EIC) muscles. This EAS's muscles
      anticipation of contraction was not found in the group of patients with UI. The observation
      that fewer patients were activating their AES's muscles, more the modulation of EAS's muscles
      contraction was distorted when coughing was made. Thubert et al. observed that the perineal
      contraction's latency was multiplied by 4 in case of cognitive load test (CLT) in an healthy
      volunteers population. CLT leads to an EAS's muscles pre activation in case of coughing
      effort, was also observed. A lowing of 29% of AES's muscles pre activation has been
      demonstrated. These results suggest that cognition is involved in urinary continence's
      physiological mechanisms. So it seamed to be interesting to study the impact of a double task
      rehabilitation (cognitive and muscular) on the urinary continence's neuromuscular mechanisms
      in case of diversion of attention. It was a randomized trial including two groups of healthy
      volunteers: one group had double task rehabilitation during 15 days, the other had no
      rehabilitation. After 15 days rehabilitation, in the rehabilitation's group, the attention
      deficit's correction restored the resistive abilities of UI in case of attention hijacking.

      According to the last AFU's (Association Française d'Urologie - Urology French Association)
      and CNGOF's (Collège national des gynécologues et obstétriciens français - French
      Gynecologists and Obstetricians National College) recommendations, the first intention
      treatment of urinary incontinence is pelvi-perineal rehabilitation. Pelvi-perineal
      rehabilitation conducted by a therapist is multimodal with different facets: a cognitive part
      (education, pelvic floor realization), a behavioral part of bladder training (modification of
      micturition habits), a muscle building part (voluntary contractions against resistance with
      and without biofeedback and electrosimulation), and also a postural work part (balance and
      pelvis position). Perineal rehabilitation technics' heterogeneity and the lack of description
      of these technics let the professionals adapt their rehabilitation's protocols. The objective
      of this study is to compare the results of two rehabilitation's technics in urinary
      incontinent patients.

      Methodology, study population, previous studies and feasibility

      Study population: The population is made of voluntary incontinent women. Inclusion criteria
      are the followings: Major women with stress urinary incontinence or mixed urinary
      incontinence or urge urinary incontinence, in need to benefit from perineal rehabilitation or
      cognitive-behavioral rehabilitation, women able to read, understand, accept and sign the
      consent. Exclusion criteria are the following: pregnant women, refusal to participate,
      dementia and cognitive troubles (Mini Mental State score: MMS <30). Participants will be
      subjects to a medical statement (antecedents, age, weight, size, UDI6 (Urogenital Distress
      Inventory) questioner, Contilife and Wexner scores). The absence of a mental deficit will be
      verifies by Mini Mental Status questioner (MMS).

      Ethical considerations: A "CPP" (comité de protection des personnes - persons' protection
      comity) have been requested and obtained for this study (N° cpp17-065a/2016-A01651-50). An
      information letter will be delivered to the volunteers, who will be included only after the
      acceptation and signature of the written consent.

      Volunteers' randomization: Participants will be randomized in two groups (1/1) with data
      processing software at the first visit at the therapist practicing the perineal
      rehabilitation. The first group will receive "Classical" perineal rehabilitation for duration
      of height weeks. The second group will receive perineal rehabilitation associated with a
      double task cognitive therapy for a duration of height weeks. Participants will be evaluated
      during the consultation.

      Initial evaluation of volunteers: initial evaluation will consist of an interrogation able to
      check the participants' antecedents and characteristics, urinary incontinence symptoms
      (quality life score (Contilife) and severity score (International Consultation on
      Incontinence Questionnaire Short Form: ICIQ-SF), Urinary Handicap Measurement (MHU - Mesure
      du Handicap Urinaire) and also clinical examination (Pelvic Organ Prolaps Quantification:
      POP-Q, Ulmsten Test, levator Testing among Oxford, ureteral mobility). In a second time, the
      EMG analysis will be realized. It consists in the analysis of the CLT impact on the voluntary
      and unvoluntary perineal contraction. The CLT used is Paced Auditory Serial addition Test
      (PASAT). Test arrangements are the followings: The volunteer will listen to an audiotape on
      witch is recorded a 61 random numbers set inconstant from 1 to 9 (for example "1, 9, 4, 5…").
      The volunteer patient will have to add each pair of number in order to add the number with
      the previous and speak verbally the response. To test the willingly perineal contraction, the
      volunteer will be in a sitting position with her arms on the armrests. The practitioner will
      position the two electrodes with self-adhesive surface from either side of the volunteer's
      anus regarding to the EAS muscle. These electrodes are usually used in a setting of classical
      evaluation with biofeedback or electro simulation. An order will be given to the volunteer in
      order to contract perineal muscles when she feels a stimulus on the left wrist (an electric
      reflex hammer regarding to the median nerve on the inside of the left wrist). The volunteer
      women will have to repeat the experience in two conditions: with and without the CLT.
      Different settings measurement will be realized: time limit for the perineal contraction
      reaction (RT), that is latency between stimulus and begins of AES's EMG activity increase.
      The other settings will be the RT max (latency between stimulus and maximum AES's EMG
      activity), maximum AES's EMG activity and air under the curve for the AES's EMG activity.
      Volunteer's perineal contraction (following coughing instruction) will also be evaluated with
      and without CLT. The coughing instruction will be ordered by an impulse (Reflex hammer) on
      the inside of the left wrist. Two more self-adhesive detection electrodes will be glued
      regarding the external intercostal muscles (7th right space). Principal data analyzed will
      be: latency between stimulus and perineal muscles (RT1) and latency between intercostal
      muscles and perineal muscles (RT3). The data set will be collected using a Biopac ®,
      Acknowledge ®.

      Classical perineal rehabilitation protocol

      Participants will benefit from two-phases perineal rehabilitation: first phase pelvic floor
      muscles (PFM)'s analytic rehabilitation, then a functional rehabilitation.

      First phase will include the PFM's awareness and voluntary contraction learning with manual,
      biofeedback technics and functional electro stimulation (FES). Then, therapist will propose
      PFM's reinforcement under the PERFECT method (Pressure, Endurance, rapid Contraction, time
      measurement between each contraction sequence). These exercises will call out the manual
      rehabilitation technics (voluntary contraction learning, pelvic anatomy), biofeedback and
      electro stimulation. Electro stimulation and biofeedback will necessit the use of an
      electrode that serves to the electromyographic measurement with and without cognitive load
      test. Each classical rehabilitation session will take 30 minutes with 20 minutes of active
      working, twice per week. About the self-training, there will be no consensus for optimal
      homemade exercises, neither on the number, nor on the duration. The different authors
      describe very different types of protocols. The self-training program will be set up as soon
      as the participant will be able to realize, under therapist's manual control, a voluntary
      analytic contraction without synergy or command reversion. Exercises' number and
      characteristic will be given according to the PERFECT Scheme.

      For the second phase, the participant will hold a micturition calendar. With the noticed
      elements, a behavior analyze will be summarized in order to update the favoring situations
      and inappropriate situations. The objective will be the learning of perineal locking and
      reinstatement of anticipative postural activity for stress urinary incontinence. The strategy
      put in place will be organized in unlearning of deleterious perineal habits and learning new
      behavior program. The functional training program will be made of activation of PFM's
      voluntary contractions during different stains of every day life; the main goal being the
      perineal locking set up (PFM's voluntary contraction associated with a good abdominal and
      perineal synergy), this locking must be systematic before and during efforts like carrying
      loads, trimming, coughing. During the second phase, the physiotherapist will twice weekly
      perform evaluations. These evaluations are similar to those in the first phase.

      Cognitive associated rehabilitation protocol: Added to the classic perineal muscular
      rehabilitation, the cognitive associated rehabilitation group randomized participants will
      have to execute twice a day the rehabilitation protocol. Each cognitive rehabilitation
      session will take three minutes. Participants will have to synergistically execute
      attentional tests (N-Back Test) and execute a perineal contraction during the contraction
      instructions. (10 randomized auditory stimuli in three minutes). The attentional tests'
      difficulty will be gradually increased each 15 days. N-Back Test modalities are the
      followings: the participant will visualize a series of random numbers. First difficulty step
      will be to click the dedicated button when the volunteer will see the indicated letter. The
      second difficulty step will be to click the dedicated button when she will see two
      consecutives times the same letter. The third difficulty step will be to click the dedicated
      button when she will see two times the same letter separated by one different letter, and so
      on… The data will be saved on the digital application.

      Methodology: Participants will consult twice per week their therapist. An intermediary
      clinical and EMG recording will be done in the fourth week to evaluate the evolution of
      symptoms and EMG's criteria, with the same arrangements as those of the first evaluation.

      Participants' final evaluation: During the last visit in the eighth week, participants will
      be evaluated with same arrangements as those of the first evaluation.

      Judgment criteria: About the involuntary perineal contraction study, the principal judgment
      criteria will be the latency between intercostal muscles contraction and perineal muscles
      contraction (RT3). Secondary judgment criteria will be: latency between stimulus and perineal
      muscles contraction (RT1) for the voluntary perineal contraction study, MHU score obtained
      (Mesure du Handicap Urinaire - urinary handicap score), ICIQ (International Consultation on
      Incontinence Questionnaire), Contilife.

      Statistic analysis:

      Descriptive data will be expressed in the form of median and interquartile gap. The Wilcoxon
      Test will be used to compare quantitative values before and after rehabilitation, and Student
      Test to compare quantitative values between "classical perineal rehabilitation" group and
      "perineal rehabilitation + cognitive therapy" group. According to the literature, middle RT3
      is -60ms, expected difference after rehabilitation is 16,66ms and known standard deviation is
      18,7ms. For an alpha risk 5% and power 80%, it is necessary to include 20 participants by
      group, whether total of 40 participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a controlled randomized single blind multicentric study on a sample of 40 women stress or mixed urinary incontinent. Participants will be randomized in two groups with a 1/1 ratio with data processing software at the first visit at the therapist practicing the perineal rehabilitation. The first group will receive "Classical" perineal rehabilitation for duration of height weeks. The second group will receive perineal rehabilitation associated to a double task cognitive therapy for duration of height weeks. Participants will be evaluated during the consultation.
primary purpose: Treatment
masking: None (Open Label)
measure: RT3 - EMG Latency between intercostal muscles contraction and perineal muscles contraction
time frame: Final evaluation at the eighth week follow up
description: EMG Latency between intercostal muscles contraction and perineal muscles contraction
measure: RT3 - EMG Latency between intercostal muscles contraction and perineal muscles
time frame: Intermediary evaluation at the fourth week follow up
description: EMG Latency between intercostal muscles contraction and perineal muscles contraction
measure: RT1 - EMG Latency between stimulus and perineal muscles contraction
time frame: Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up
description: EMG Latency between stimulus and perineal muscles contraction
measure: Urinary Handicap Measurement (Mesure du Handicap Urinaire - MHU)
time frame: Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up
description: Urinary Handicap Measurement is a quantitative measurement of different urinary symptoms, with 7 different questions, each response is associated to a value from 0 to 4, and with a final score from 0 (lowest score, no symptoms of urinary incontinence) to 28 (Higher score, maximum urinary incontinence symptoms).
measure: International Consultation on Incontinence Questionnaire (ICIQ-SF)
time frame: Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up
description: The ICIQ SF is a subjective measurement of severity of urinary loss and quality of life for those with urinary incontinence. It has 4 main items (of 6 total) ask for rating of symptoms in the past 4 weeks. The actual score takes sum score of items 3+4+5 (items 1 and 2 are demographic). The final item (6) is self diagnostic item that is unscored.
Final score is from 0 (lowest score, no symptoms of urinary incontinence), to 21 (Higher score, maximum urinary incontinence symptoms).
measure: Questionnaire for assessment of quality of life related to women urinary incontinence (Contilife)
time frame: Intermediary evaluation at the fourth week follow up, and final evaluation at the eighth week follow up
description: Auto survey of 28 questions for the quality of life related to the women with urinary incontinence. There are 6 main subjects related to quality of life, and each question has a score from 0 or 1 to 5. The final score is Final score is from 23 (lowest score, no impact of urinary incontinence on quality of life), to 140 (Higher score, maximum impact of urinary incontinence on quality of life).
arm group label: Classical rehabilitation
arm group type: Active Comparator
description: Twenty women will benefit from two-phases perineal rehabilitation: first phase pelvic floor muscles (PFM)'s analytic rehabilitation, then a functional rehabilitation.
arm group label: Classical and cognitive associated rehabilitation
arm group type: Experimental
description: Twenty women will receive, added to the classic perineal rehabilitation, the cognitive rehabilitation and will have to execute twice a day the rehabilitation protocol.
intervention type: Other
intervention name: Classical rehabilitation
description: Participants will benefit from two-phases perineal rehabilitation:
First phase will include the PFM's awareness and voluntary contraction learning with manual, biofeedback technics and functional electro stimulation. These exercises will call out the manual rehabilitation technics, biofeedback and electro stimulation. Each classical rehabilitation session will take 30 minutes with 20 minutes of active working, twice per week. About the self-training, there will be no consensus for optimal homemade exercises.
For the second phase, a behavior analyze will be summarized in order to update the favoring and inappropriate situations. The strategy put in place will be organized in unlearning of deleterious perineal habits and learning new behavior program. The main goal will be the perineal locking set up, which must be systematic before and during efforts. During this phase, the physiotherapist will twice weekly perform evaluations (similar to those in the first phase)
arm group label: Classical rehabilitation
intervention type: Behavioral
intervention name: Cognitive associated rehabilitation
description: The cognitive associated rehabilitation group randomized participants will have to execute twice a day the rehabilitation protocol. Each cognitive rehabilitation session will take three minutes. Participants will have to synergistically execute attentional tests (N-Back Test) and execute a perineal contraction during the contraction instructions. (10 randomized auditory stimuli in three minutes). The attentional tests' difficulty will be gradually increased each 15 days. N-Back Test modalities are the followings: the participant will visualize a series of random numbers. First difficulty step will be to click the dedicated button when the volunteer will see the indicated letter. The second difficulty step will be to click the dedicated button when she will see two consecutives times the same letter. The third difficulty step will be to click the dedicated button when she will see two times the same letter separated by one different letter, and so on…
arm group label: Classical and cognitive associated rehabilitation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Thibault THUBERT, MD
role: Principal Investigator
affiliation: CHU Hotel Dieu Nantes
last name: Pierre-André MAL, resident
role: Study Chair
affiliation: CHU Hopital Tenon APHP
last name: Thibault THUBERT, MD
phone: +33647697800
email: Thibault.thubert@chu-nantes.fr
last name: Pierre-André MAL, resident
phone: +33659363500
email: malpierreandre@gmail.com
citation: Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8. doi: 10.1053/apmr.2001.24297.
PMID: 11494188
citation: Amarenco G, Ismael SS, Lagauche D, Raibaut P, Rene-Corail P, Wolff N, Thoumie P, Haab F. Cough anal reflex: strict relationship between intravesical pressure and pelvic floor muscle electromyographic activity during cough. Urodynamic and electrophysiological study. J Urol. 2005 Jan;173(1):149-52. doi: 10.1097/01.ju.0000147305.00443.df.
PMID: 15592060
citation: Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. External intercostal muscles and external anal sphincter electromyographic activity during coughing. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Apr;19(4):521-4. doi: 10.1007/s00192-007-0473-y. Epub 2007 Oct 13.
PMID: 17934686
citation: Fritel X, Fauconnier A, Bader G, Cosson M, Debodinance P, Deffieux X, Denys P, Dompeyre P, Faltin D, Fatton B, Haab F, Hermieux JF, Kerdraon J, Mares P, Mellier G, Michel-Laaengh N, Nadeau C, Robain G, de Tayrac R, Jacquetin B; French College of Gynaecologists and Obstetricians. Diagnosis and management of adult female stress urinary incontinence: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):14-9. doi: 10.1016/j.ejogrb.2010.02.041. Epub 2010 Mar 16.
PMID: 20236751
citation: Hermieu JF, Denys P, Fritel X. [Critical review of guidelines for female urinary incontinence diagnosis and treatment]. Prog Urol. 2012 Oct;22(11):636-43. doi: 10.1016/j.purol.2012.08.004. Epub 2012 Sep 10. French.
PMID: 22999088
citation: Klovning A, Avery K, Sandvik H, Hunskaar S. Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn. 2009;28(5):411-5. doi: 10.1002/nau.20674.
PMID: 19214996
citation: Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
PMID: 10813117
citation: Horton AM Jr, Alana S. Validation of the Mini-Mental State Examination. Int J Neurosci. 1990 Aug;53(2-4):209-12. doi: 10.3109/00207459008986604.
PMID: 2265941
citation: Thubert T, Villot A, Billecocq S, Auclair L, Amarenco G, Deffieux X. Influence of a distraction task on the involuntary reflex contraction of the pelvic floor muscles following cough. Neurourol Urodyn. 2017 Jan;36(1):160-165. doi: 10.1002/nau.22903. Epub 2015 Oct 9.
PMID: 26451967
citation: Thubert T, Deffieux X, Jousse M, Guinet-Lacoste A, Ismael SS, Amarenco G. Influence of a distraction task on pelvic floor muscle contraction. Neurourol Urodyn. 2015 Feb;34(2):139-43. doi: 10.1002/nau.22524. Epub 2014 Feb 12.
PMID: 24519688
citation: Villot A, Deffieux X, Billecocq S, Auclair L, Amarenco G, Thubert T. Influence of cognitive rehabilitation on pelvic floor muscle contraction: A randomized controlled trial. Neurourol Urodyn. 2017 Aug;36(6):1636-1644. doi: 10.1002/nau.23169. Epub 2016 Oct 29.
PMID: 27794195
citation: Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Pelvic floor muscle activity during coughing: altered pattern in women with stress urinary incontinence. Urology. 2007 Sep;70(3):443-7; discussion 447-8. doi: 10.1016/j.urology.2007.03.084.
PMID: 17905093
citation: Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Abnormal pelvic response to cough in women with stress urinary incontinence. Neurourol Urodyn. 2008;27(4):291-6. doi: 10.1002/nau.20506.
PMID: 17803192
responsible party type: Principal Investigator
investigator affiliation: Pierre and Marie Curie University
investigator full name: Thubert Thibault
investigator title: Principal Investigator, Medical Doctor of Gynecology
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Urinary Incontinence, Urge
sharing ipd: Undecided