<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/NCT01705535</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2012-067</org_study_id>
    <secondary_id>H-2-2012-067</secondary_id>
    <nct_id>NCT01705535</nct_id>
  </id_info>
  <brief_title>The Effect of Physiotherapy for the Treatment of Fecal Incontinence.</brief_title>
  <official_title>The Effect of Physiotherapy for the Treatment of Fecal Incontinence - a Randomized, Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Copenhagen University Hospital, Hvidovre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fecal incontinence is the complaint of involuntary loss of feces. Fecal incontinence affects&#xD;
      2-12% of the adult population. It is a hidden problem - less than one third of the affected&#xD;
      persons discuss the problem with their doctor. The condition has a negative effect on quality&#xD;
      of life. It is associated with shame and limitation in social life, leisure, occupational and&#xD;
      sexual activities.&#xD;
&#xD;
      Pelvic floor muscle exercises with or without the use of biofeedback has been recommended and&#xD;
      used for the treatment of fecal incontinence over the last decades. Several uncontrolled&#xD;
      trials and some controlled trials have shown a positive effect of this training, but most of&#xD;
      the trials are small and/or have methodological problems. Therefore there is to day still a&#xD;
      lack of sufficient evidence for the effect of pelvic floor muscle exercise as a treatment of&#xD;
      fecal incontinence.&#xD;
&#xD;
      The aim of this study is to compare the effect of an individual physiotherapeutic supervised&#xD;
      pelvic floor muscle training program with a control physiotherapeutic treatment (massage of&#xD;
      the neck and back). Both treatments will be given parallel with standard information and&#xD;
      guidance given by a nurse specialized in anal incontinence issues.&#xD;
&#xD;
      Study hypothesis: Pelvic floor muscle exercises given parallel with standard advice and&#xD;
      guidance by a specialized nurse, provides better effect to reducing fecal incontinence than&#xD;
      control treatment and standard advice alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, investigator blinded, randomized controlled trial with two parallel arms. 100&#xD;
      participants will be randomized to one of two groups. Ratio 1:1. Baseline data consists of a&#xD;
      physical examination, anal ultrasound and a thorough medical history including age, duration&#xD;
      of complaints, fecal incontinence specific symptoms and known risk factors for fecal&#xD;
      incontinence.&#xD;
&#xD;
      Group 1 will receive standard information and guidance and care by a specialized nurse. The&#xD;
      treatment consists of advice about diet and fiber supplements and information about&#xD;
      optimizing bowel emptying and use of antidiarrheal medication if appropriate. In addition the&#xD;
      participants will receive six individual treatments of 30 minutes by a physiotherapist. This&#xD;
      treatments will consist of massage of the back and neck. The participants will get no&#xD;
      instructions on pelvic floor muscle exercises.&#xD;
&#xD;
      Group 2 will receive the same information and guidance by a specialist nurse as group 1. In&#xD;
      addition they will receive six individual treatments of 45 minutes by a physiotherapist&#xD;
      specialized in incontinence problems and pelvic floor disorders. The participants will get&#xD;
      instructions in the anatomy and function of the pelvic floor muscles and instructions on how&#xD;
      to do a correct pelvic floor muscle contraction. The pelvic floor muscle exercises will be&#xD;
      taught both by verbal instructions and by vaginal and anal palpation. For each session by the&#xD;
      physiotherapist, the participants will get a physiotherapeutic examination of the pelvic&#xD;
      floor muscles by a vaginal and rectal examination. The pelvic floor muscle and the external&#xD;
      anal sphincter strength will be measured according to the Modified Oxford Score (ranging&#xD;
      0-5). Endurance of sub-maximal contractions will be determined. The function of pelvic floor&#xD;
      muscle will also be measured with intra-anal EMG biofeedback. Biofeedback will be used to&#xD;
      give the participant visual and auditory feedback on a correct pelvic floor muscle&#xD;
      contraction to enhance the participants awareness, strength and endurance of a correct pelvic&#xD;
      floor muscle contraction. Biofeedback will also be used in sitting and standing position to&#xD;
      assess the pelvic floor muscle function in those positions. According to the findings of the&#xD;
      physiotherapeutic examinations there will be prepared an individual adapted pelvic floor&#xD;
      muscle training program. The program consists of 3 sets of 10 contractions sustained up till&#xD;
      10 seconds and 2 sets of 3 contractions sustained up till 30 seconds. 1 minute rest between&#xD;
      each set. The participants will also be instructed in how to contract the pelvic floor in&#xD;
      response to anal urgency and in situations with increased intra abdominal pressure. The&#xD;
      participants will be encouraged to perform the training program on a daily basis and will be&#xD;
      instructed in filling out a training dairy. The diary will be used as a motivational tool and&#xD;
      to quantify the amount of training. The individual training program will be adjusted, based&#xD;
      on the findings from the examinations, and participants will be instructed to perform the&#xD;
      exercises in different positions and during movements e.g. transfers, lifting, walking,&#xD;
      coughing.&#xD;
&#xD;
      The treatments in both groups will be distributed over 16 weeks, with treatment in week&#xD;
      0,2,5,8,12 and 16.&#xD;
&#xD;
      Note 15. februar 2016:&#xD;
&#xD;
      Due to logistical reasons, we failed to perform the 12 months follow-up in the first 15&#xD;
      patients, which is why we decided to change the follow-up from 12 months to 36 months. This&#xD;
      will enable us to perform a long-term outcome assessment for all included patients. This&#xD;
      change does not affect the pre-specified primary endpoint.&#xD;
&#xD;
      In order to achieve as high respond rate as possible we decided to restrict the follow-up&#xD;
      measurement to the questionnaires: Patient Global Impression of Improvement Scale (PGI-I&#xD;
      scale), Fecal Incontinence Severity Index (FISI), St. Marks Incontinence Score (Vaizey) and&#xD;
      Fecal Incontinence Quality of Life Scale (FIQL). Questions about further treatment for fecal&#xD;
      incontinence since completion of the study and the amount of current pelvic floor muscle&#xD;
      exercise will be added.&#xD;
&#xD;
      We thus decided to omit anal manometry, rectal capacity measurement and diaries from the 36&#xD;
      months follow-up measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Global Impression of Improvement Scale (PGI-I Scale)</measure>
    <time_frame>Within 2 weeks after completion of intervention (16 weeks post baseline, primary analysis) Futher assessment: 12 month (follow-up).</time_frame>
    <description>Patients are asked to compare their incontinence symptoms before and after treatment and to rate changes on a seven point scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fecal Incontinence Severity Index</measure>
    <time_frame>Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).</time_frame>
    <description>Change from baseline in Fecal Incontinence Severity Index (0-61 points) at 16 weeks.&#xD;
Severity score for fecal incontinence ranging from 0-61. 0=complete continence, 61=complete incontinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St. Marks Incontinence Score (Vaizey Score)</measure>
    <time_frame>Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).</time_frame>
    <description>Change from baseline in St. Marks Incontinence Score (0-24 points) at 16 weeks. Score measuring fecal incontinence severity, ranging from 0-24. 0= complete continence, 24= complete incontinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anal manometry</measure>
    <time_frame>Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).</time_frame>
    <description>Changes from baseline in resting and squeeze pressure of the anal canal at 16 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rectal capacity measurement</measure>
    <time_frame>Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).</time_frame>
    <description>Changes from baseline in sensory threshold, urge sensation, and maximum tolerable volume at 16 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incontinence dairy</measure>
    <time_frame>Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).</time_frame>
    <description>Changes from baseline in a incontinence dairy at 16 weeks. Participants are asked to fill out a two weeks incontinence dairy. The dairy gives insight into the defecation pattern, number of incontinence episode, presence of urge sensation, presence of urinary incontinence, presence of soiling, pad use and limitations in daily activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal Incontinence Quality of Life</measure>
    <time_frame>Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).</time_frame>
    <description>Changes from baseline in Fecal Incontinence Quality of Life at 16 weeks. Fecal incontinence specific quality of life assessment. Consists of four subscales with 29 questions in total. The subscales are lifestyle, coping/behavior, depression/self-perception and embarrassment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Training diary</measure>
    <time_frame>During intervention and again at follow-up 1 year after completion of the intervention.</time_frame>
    <description>Participants in the training group records the amount and duration of pelvic floor muscle exercises conducted each day during the intervention period and again over 1 week at follow-up</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Pelvic floor muscle exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual supervised pelvic floor muscle exercises. Standard information and guidance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Masage of the neck and back</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Massage of the neck and back. Standard information and guidance</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual supervised pelvic floor muscle exercises</intervention_name>
    <description>Six individual treatments of 45 minutes by a physiotherapist specialized in pelvic floor disorders. Preparation of an individual adapted training program for the pelvic floor muscles. Encouragement to perform the pelvic floor muscle training program on a daily basis</description>
    <arm_group_label>Pelvic floor muscle exercises</arm_group_label>
    <other_name>Pelvic floor muscle training</other_name>
    <other_name>Physiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massage of the neck and back</intervention_name>
    <description>six individual treatments of 30 minutes by a physiotherapist. The participants will get no instructions of pelvic floor muscle exercises.</description>
    <arm_group_label>Masage of the neck and back</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard information and guidance</intervention_name>
    <description>Advice about diet and fiber supplements. Information about optimizing bowel emptying including use of medicine. Advice about use of antidiarrheal medication if appropriate.</description>
    <arm_group_label>Masage of the neck and back</arm_group_label>
    <arm_group_label>Pelvic floor muscle exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients refered to examination and treatment of fecal incontinence at the Department&#xD;
             of surgical and medical Gastroenterology at Hvidovre University Hospital.&#xD;
&#xD;
          -  Duration of fecal incontinence for at least 6 month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who has received more than 2 sessions of individual instructions of&#xD;
             pelvic floor muscle exercises by a physiotherapist during the last 12 month.&#xD;
&#xD;
          -  Chronic diarrhea&#xD;
&#xD;
          -  Severe neurological disorders (multiple sclerosis, parkinsons, spinal cord&#xD;
             injury,stroke or neuromuscular junction disease.&#xD;
&#xD;
          -  Rectal prolapse&#xD;
&#xD;
          -  Previously cancer operation or radiotherapy in the lower abdomen&#xD;
&#xD;
          -  Linguistically and/or cognitively incapable of understanding how to perform the pelvic&#xD;
             floor muscle training program&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anja Ussing</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hvidovre University Hospital Denmark, Department of Physiotherapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Physiotherapy, Hvidovre University Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2650 Hvidovre</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>August 6, 2018</last_update_submitted>
  <last_update_submitted_qc>August 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
    <investigator_full_name>Anja Ussing</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Fecal incontinence</keyword>
  <keyword>Pelvic floor muscle exercises</keyword>
  <keyword>Physiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <!-- 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/NCT01705535
org study id: H-2-2012-067
secondary id: H-2-2012-067
nct id: NCT01705535
lead sponsor: 
has dmc: No
Fecal incontinence is the complaint of involuntary loss of feces. Fecal incontinence affects
      2-12% of the adult population. It is a hidden problem - less than one third of the affected
      persons discuss the problem with their doctor. The condition has a negative effect on quality
      of life. It is associated with shame and limitation in social life, leisure, occupational and
      sexual activities.

      Pelvic floor muscle exercises with or without the use of biofeedback has been recommended and
      used for the treatment of fecal incontinence over the last decades. Several uncontrolled
      trials and some controlled trials have shown a positive effect of this training, but most of
      the trials are small and/or have methodological problems. Therefore there is to day still a
      lack of sufficient evidence for the effect of pelvic floor muscle exercise as a treatment of
      fecal incontinence.

      The aim of this study is to compare the effect of an individual physiotherapeutic supervised
      pelvic floor muscle training program with a control physiotherapeutic treatment (massage of
      the neck and back). Both treatments will be given parallel with standard information and
      guidance given by a nurse specialized in anal incontinence issues.

      Study hypothesis: Pelvic floor muscle exercises given parallel with standard advice and
      guidance by a specialized nurse, provides better effect to reducing fecal incontinence than
      control treatment and standard advice alone.
Prospective, investigator blinded, randomized controlled trial with two parallel arms. 100
      participants will be randomized to one of two groups. Ratio 1:1. Baseline data consists of a
      physical examination, anal ultrasound and a thorough medical history including age, duration
      of complaints, fecal incontinence specific symptoms and known risk factors for fecal
      incontinence.

      Group 1 will receive standard information and guidance and care by a specialized nurse. The
      treatment consists of advice about diet and fiber supplements and information about
      optimizing bowel emptying and use of antidiarrheal medication if appropriate. In addition the
      participants will receive six individual treatments of 30 minutes by a physiotherapist. This
      treatments will consist of massage of the back and neck. The participants will get no
      instructions on pelvic floor muscle exercises.

      Group 2 will receive the same information and guidance by a specialist nurse as group 1. In
      addition they will receive six individual treatments of 45 minutes by a physiotherapist
      specialized in incontinence problems and pelvic floor disorders. The participants will get
      instructions in the anatomy and function of the pelvic floor muscles and instructions on how
      to do a correct pelvic floor muscle contraction. The pelvic floor muscle exercises will be
      taught both by verbal instructions and by vaginal and anal palpation. For each session by the
      physiotherapist, the participants will get a physiotherapeutic examination of the pelvic
      floor muscles by a vaginal and rectal examination. The pelvic floor muscle and the external
      anal sphincter strength will be measured according to the Modified Oxford Score (ranging
      0-5). Endurance of sub-maximal contractions will be determined. The function of pelvic floor
      muscle will also be measured with intra-anal EMG biofeedback. Biofeedback will be used to
      give the participant visual and auditory feedback on a correct pelvic floor muscle
      contraction to enhance the participants awareness, strength and endurance of a correct pelvic
      floor muscle contraction. Biofeedback will also be used in sitting and standing position to
      assess the pelvic floor muscle function in those positions. According to the findings of the
      physiotherapeutic examinations there will be prepared an individual adapted pelvic floor
      muscle training program. The program consists of 3 sets of 10 contractions sustained up till
      10 seconds and 2 sets of 3 contractions sustained up till 30 seconds. 1 minute rest between
      each set. The participants will also be instructed in how to contract the pelvic floor in
      response to anal urgency and in situations with increased intra abdominal pressure. The
      participants will be encouraged to perform the training program on a daily basis and will be
      instructed in filling out a training dairy. The diary will be used as a motivational tool and
      to quantify the amount of training. The individual training program will be adjusted, based
      on the findings from the examinations, and participants will be instructed to perform the
      exercises in different positions and during movements e.g. transfers, lifting, walking,
      coughing.

      The treatments in both groups will be distributed over 16 weeks, with treatment in week
      0,2,5,8,12 and 16.

      Note 15. februar 2016:

      Due to logistical reasons, we failed to perform the 12 months follow-up in the first 15
      patients, which is why we decided to change the follow-up from 12 months to 36 months. This
      will enable us to perform a long-term outcome assessment for all included patients. This
      change does not affect the pre-specified primary endpoint.

      In order to achieve as high respond rate as possible we decided to restrict the follow-up
      measurement to the questionnaires: Patient Global Impression of Improvement Scale (PGI-I
      scale), Fecal Incontinence Severity Index (FISI), St. Marks Incontinence Score (Vaizey) and
      Fecal Incontinence Quality of Life Scale (FIQL). Questions about further treatment for fecal
      incontinence since completion of the study and the amount of current pelvic floor muscle
      exercise will be added.

      We thus decided to omit anal manometry, rectal capacity measurement and diaries from the 36
      months follow-up measurements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Patient Global Impression of Improvement Scale (PGI-I Scale)
time frame: Within 2 weeks after completion of intervention (16 weeks post baseline, primary analysis) Futher assessment: 12 month (follow-up).
description: Patients are asked to compare their incontinence symptoms before and after treatment and to rate changes on a seven point scale.
measure: Fecal Incontinence Severity Index
time frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
description: Change from baseline in Fecal Incontinence Severity Index (0-61 points) at 16 weeks.
Severity score for fecal incontinence ranging from 0-61. 0=complete continence, 61=complete incontinence.
measure: St. Marks Incontinence Score (Vaizey Score)
time frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
description: Change from baseline in St. Marks Incontinence Score (0-24 points) at 16 weeks. Score measuring fecal incontinence severity, ranging from 0-24. 0= complete continence, 24= complete incontinence.
measure: Anal manometry
time frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
description: Changes from baseline in resting and squeeze pressure of the anal canal at 16 weeks
measure: Rectal capacity measurement
time frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
description: Changes from baseline in sensory threshold, urge sensation, and maximum tolerable volume at 16 weeks.
measure: Incontinence dairy
time frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
description: Changes from baseline in a incontinence dairy at 16 weeks. Participants are asked to fill out a two weeks incontinence dairy. The dairy gives insight into the defecation pattern, number of incontinence episode, presence of urge sensation, presence of urinary incontinence, presence of soiling, pad use and limitations in daily activities
measure: Fecal Incontinence Quality of Life
time frame: Pre intervention start (baseline) and 16 weeks post baseline (primary analysis) Futher assessment: 12 month (follow-up).
description: Changes from baseline in Fecal Incontinence Quality of Life at 16 weeks. Fecal incontinence specific quality of life assessment. Consists of four subscales with 29 questions in total. The subscales are lifestyle, coping/behavior, depression/self-perception and embarrassment.
measure: Training diary
time frame: During intervention and again at follow-up 1 year after completion of the intervention.
description: Participants in the training group records the amount and duration of pelvic floor muscle exercises conducted each day during the intervention period and again over 1 week at follow-up
arm group label: Pelvic floor muscle exercises
arm group type: Experimental
description: Individual supervised pelvic floor muscle exercises. Standard information and guidance
arm group label: Masage of the neck and back
arm group type: Active Comparator
description: Massage of the neck and back. Standard information and guidance
intervention type: Behavioral
intervention name: Individual supervised pelvic floor muscle exercises
description: Six individual treatments of 45 minutes by a physiotherapist specialized in pelvic floor disorders. Preparation of an individual adapted training program for the pelvic floor muscles. Encouragement to perform the pelvic floor muscle training program on a daily basis
arm group label: Pelvic floor muscle exercises
other name: Pelvic floor muscle training
other name: Physiotherapy
intervention type: Other
intervention name: Massage of the neck and back
description: six individual treatments of 30 minutes by a physiotherapist. The participants will get no instructions of pelvic floor muscle exercises.
arm group label: Masage of the neck and back
intervention type: Behavioral
intervention name: Standard information and guidance
description: Advice about diet and fiber supplements. Information about optimizing bowel emptying including use of medicine. Advice about use of antidiarrheal medication if appropriate.
arm group label: Masage of the neck and back
arm group label: Pelvic floor muscle exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anja Ussing
role: Principal Investigator
affiliation: Hvidovre University Hospital Denmark, Department of Physiotherapy
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Copenhagen University Hospital, Hvidovre
investigator full name: Anja Ussing
investigator title: Physiotherapist
mesh term: Fecal Incontinence