<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/NCT03005977</url>
  </required_header>
  <id_info>
    <org_study_id>FLA 16-078</org_study_id>
    <nct_id>NCT03005977</nct_id>
  </id_info>
  <brief_title>Identifying Stress Urinary Incontinence in Women With Pelvic Organ Prolapse</brief_title>
  <official_title>What Test is Most Sensitive in Identifying Stress Urinary Incontinence in Women With Pelvic Organ Prolapse; Urodynamics, Standing Cough Stress Test, or Pyridium Pad Test?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
      What test is most sensitive in identifying stress urinary incontinence in women with pelvic&#xD;
      organ prolapse; urodynamics, cough stress test, or pyridium pad test? The hypothesis states&#xD;
      that there is a difference between the sensitivity of UDS, pyridium pad test and cough stress&#xD;
      tests, with UDS being the most sensitive and the gold standard in identifying SUI in patients&#xD;
      with pelvic organ prolapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic organ prolapse (POP) is the descent of the pelvic organs into or through the vagina.&#xD;
      It is seen in about 11% of the female population by age 80 years old and is often treated&#xD;
      with surgery. For patients with pelvic organ prolapse a complaint of de novo stress urinary&#xD;
      incontinence (SUI), potential, or occult SUI after prolapse surgery is well-documented. This&#xD;
      new onset of incontinence ranges from 6-60% of the time and therefore, patients who undergo&#xD;
      surgery for POP are at risk for needing a subsequent procedure if SUI is not identified prior&#xD;
      to the pelvic reconstruction.&#xD;
&#xD;
      Pre-operative evaluation for SUI includes a history and physical exam. The physical exam may&#xD;
      include an empty supine stress test ESST, standing cough stress test (CST), pyridium pad&#xD;
      test, and urodynamics (UDS). Prior studies have been performed to determine which of these&#xD;
      tests are best at identifying SUI. One systemic review found that UDS was 92% sensitive in&#xD;
      identifying SUI. When comparing UDS to the cough stress test and the weighed pyridium pad&#xD;
      test, the cough stress test was found to be 90% sensitive and the pyridium pad test only 60%&#xD;
      sensitive. The pyridium pad test was 68% sensitive when a pad test was found to be positive&#xD;
      by orange color stain noted on the pad.&#xD;
&#xD;
      The various ways these tests are performed have also been evaluated. For example, there was&#xD;
      no statistical difference in outcomes of a CST; whether completed supine or standing and&#xD;
      independent of bladder volume. In regards to the pyridium pad tests, several studies have&#xD;
      compared a 1 hour to 24 hour pyridium pad test with varying results of efficacy. Furthermore,&#xD;
      in a study done when comparing pad weight and color, even asymptomatic women had positive&#xD;
      pyridium pad tests suggesting this test is less specific in identifying SUI. A secondary&#xD;
      analysis of the looked at how different reduction methods effect the predictability of&#xD;
      post-operative SUI on UDS. Reduction of pelvic organ prolapse with a speculum was the most&#xD;
      sensitive in identifying post-operative SUI at 53%. However, there is a paucity of evidence&#xD;
      as to which pre-operative test is best in identifying SUI in patients with pelvic organ&#xD;
      prolapse.&#xD;
&#xD;
      In this prospective study, the aim is to determine which test is most sensitive in&#xD;
      pre-operatively identifying SUI and occult SUI in patients treated for prolapse. The&#xD;
      hypothesis states that there is a difference between the sensitivity of UDS, pyridium pad&#xD;
      test and cough stress tests, with UDS being the most sensitive and the gold standard in&#xD;
      identifying SUI in patients with pelvic organ prolapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with SUI as per Pelvic Floor Bother Questionnaire prior to prolapse surgery compared to number of patients with clinical SUI identified on either UDS, pyridium pad test and cough stress test.</measure>
    <time_frame>2 years</time_frame>
    <description>Pelvic Floor Bother Questionnaire:A comparison will be made for each patient across the three studies to identify which test is most predictive of patient's SUI indicated by leakage identified on patients pre-operative questionnaire: Pelvic Floor Bother Questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with SUI as per the Urogenital Distress Inventory (UDI-6):Questionnaire prior to prolapse surgery compared to number of patients with clinical SUI identified on either UDS, pyridium pad test and cough stress test.</measure>
    <time_frame>2 years</time_frame>
    <description>The Urogenital Distress Inventory (UDI-6):A comparison will be made for each patient across the three studies to identify which test is most predictive of patient's SUI indicated by leakage identified on patients pre-operative questionnaire: the Urogenital Distress Inventory (UDI-6)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with SUI as per The numerical analog scale prior to prolapse surgery compared to number of patients with clinical SUI identified on either UDS, pyridium pad test and cough stress test.</measure>
    <time_frame>2 years</time_frame>
    <description>The numerical analog scale.A comparison will be made for each patient across the three studies to identify which test is most predictive of patient's SUI indicated by leakage identified on patients pre-operative questionnaire: the numerical analog scale.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <arm_group>
    <arm_group_label>Urodynamics, pyridium pad &amp; cough stress</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Pelvic Floor Bother Questionnaire, a questionnaire standardized by Cleveland Clinic Florida, the Urogenital Distress Inventory (UDI-6), and the numerical analog scale are to be administered prior to and 6 weeks after the surgical intervention. (14, 15)&#xD;
Prior to surgery, patients will be scheduled for a UDS performed by a qualified nurse practitioner or physician and will be given instructions in verbal and written form to undergo a 24 H pyridium pad test at least 72 hours before the UDS. Patients will be given pyridium TID and report if orange stain is noted on their pad in this period of time. A supine and a standing cough stress test will also be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Urodynamics</intervention_name>
    <description>UDS is to be performed with prolapse reduced by a speculum. The patient will be asked to valsalva three times then cough while seated after 150 ml of fluid is instilled in the bladder and then again at 300 ml. The same provocative measures will be performed at capacity, with the catheter in place and without the catheter if no leak is identified. If the patient leaks at any volume or if the patient leaks during the cough pressure profile (CPP), the test will be considered positive. If the patient does not leak during filling nor during the CPP then the test will be considered negative.</description>
    <arm_group_label>Urodynamics, pyridium pad &amp; cough stress</arm_group_label>
    <other_name>24 hour pyridium pad test</other_name>
    <other_name>Cough stress test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 y/o or greater&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
          -  Stage 2 or greater prolapse&#xD;
&#xD;
          -  With or without complaint of stress urinary incontinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Desire non-surgical management&#xD;
&#xD;
          -  Prior surgery for prolapse or incontinence&#xD;
&#xD;
          -  Treated medically for incontinence in the past 4 weeks&#xD;
&#xD;
          -  Current Infection&#xD;
&#xD;
          -  Known neurologic condition&#xD;
&#xD;
          -  Stage 3 or greater chronic kidney disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Hurtado, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.</citation>
    <PMID>9083302</PMID>
  </reference>
  <reference>
    <citation>Latini JM, Kreder KJ Jr. Associated pelvic organ prolapse in women with stress urinary incontinence: when to operate? Curr Opin Urol. 2005 Nov;15(6):380-5. doi: 10.1097/01.mou.0000179760.45715.9b.</citation>
    <PMID>16205487</PMID>
  </reference>
  <reference>
    <citation>Kasturi S, Diaz SI, McDermott CD, Woodman PJ, Bump RC, Terry CL, Hale DS. De novo stress urinary incontinence after negative prolapse reduction stress testing for total vaginal mesh procedures: incidence and risk factors. Am J Obstet Gynecol. 2011 Nov;205(5):487.e1-4. doi: 10.1016/j.ajog.2011.07.006. Epub 2011 Jul 20.</citation>
    <PMID>21925638</PMID>
  </reference>
  <reference>
    <citation>Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.</citation>
    <PMID>22716974</PMID>
  </reference>
  <reference>
    <citation>Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.</citation>
    <PMID>16611949</PMID>
  </reference>
  <reference>
    <citation>Martin JL, Williams KS, Abrams KR, Turner DA, Sutton AJ, Chapple C, Assassa RP, Shaw C, Cheater F. Systematic review and evaluation of methods of assessing urinary incontinence. Health Technol Assess. 2006 Feb;10(6):1-132, iii-iv. doi: 10.3310/hta10060.</citation>
    <PMID>16487456</PMID>
  </reference>
  <reference>
    <citation>Price DM, Noblett K. Comparison of the cough stress test and 24-h pad test in the assessment of stress urinary incontinence. Int Urogynecol J. 2012 Apr;23(4):429-33. doi: 10.1007/s00192-011-1602-1. Epub 2011 Nov 16.</citation>
    <PMID>22086265</PMID>
  </reference>
  <reference>
    <citation>Reena C, Kekre AN, Kekre N. Occult stress incontinence in women with pelvic organ prolapse. Int J Gynaecol Obstet. 2007 Apr;97(1):31-4. doi: 10.1016/j.ijgo.2006.12.011. Epub 2007 Feb 8.</citation>
    <PMID>17291508</PMID>
  </reference>
  <reference>
    <citation>W. Henderson, S. Kane, J. Mangel, J. Garibay, E. Kikano, R. Pollard, S. T. Mahajan, A. Hijaz. A randomized comparative study correlating cough stress test with urodynamics and 24 hour pad test in the evaluation of stress urinary incontinence. J. Female Pelvic Medicine &amp; Reconstructive Surgery Issue: September/October 2015. Volume 21(5) Supplement 1, p S11</citation>
  </reference>
  <reference>
    <citation>Artibani, W; Andersen, JT; Gajewski, JB; Ostergard, DR; Raz, S; Tubaro, A; Chapter 8C imaging and other Investigations. 2nd International Consultation on Incontinence 2002 p425-477</citation>
  </reference>
  <reference>
    <citation>Wall LL, Wang K, Robson I, Stanton SL. The Pyridium pad test for diagnosing urinary incontinence. A comparative study of asymptomatic and incontinent women. J Reprod Med. 1990 Jul;35(7):682-4.</citation>
    <PMID>2198349</PMID>
  </reference>
  <reference>
    <citation>Visco AG, Brubaker L, Nygaard I, Richter HE, Cundiff G, Fine P, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):607-14. doi: 10.1007/s00192-007-0498-2. Epub 2008 Jan 9.</citation>
    <PMID>18185903</PMID>
  </reference>
  <reference>
    <citation>Peterson TV, Karp DR, Aguilar VC, Davila GW. Validation of a global pelvic floor symptom bother questionnaire. Int Urogynecol J. 2010 Sep;21(9):1129-35. doi: 10.1007/s00192-010-1148-7. Epub 2010 May 11.</citation>
    <PMID>20458467</PMID>
  </reference>
  <reference>
    <citation>Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.</citation>
    <PMID>7780440</PMID>
  </reference>
  <results_reference>
    <citation>Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.</citation>
    <PMID>19937315</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Eric Hurtado</investigator_full_name>
    <investigator_title>Urogynecology Clinical Fellow</investigator_title>
  </responsible_party>
  <keyword>Urodynamics</keyword>
  <keyword>Pyridium pad test</keyword>
  <keyword>Cough stress test</keyword>
  <keyword>Pelvic organ prolapse</keyword>
  <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>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data individual participant data will not be shared with other researches.</ipd_description>
  </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/NCT03005977
org study id: FLA 16-078
nct id: NCT03005977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
What test is most sensitive in identifying stress urinary incontinence in women with pelvic
      organ prolapse; urodynamics, cough stress test, or pyridium pad test? The hypothesis states
      that there is a difference between the sensitivity of UDS, pyridium pad test and cough stress
      tests, with UDS being the most sensitive and the gold standard in identifying SUI in patients
      with pelvic organ prolapse.
Pelvic organ prolapse (POP) is the descent of the pelvic organs into or through the vagina.
      It is seen in about 11% of the female population by age 80 years old and is often treated
      with surgery. For patients with pelvic organ prolapse a complaint of de novo stress urinary
      incontinence (SUI), potential, or occult SUI after prolapse surgery is well-documented. This
      new onset of incontinence ranges from 6-60% of the time and therefore, patients who undergo
      surgery for POP are at risk for needing a subsequent procedure if SUI is not identified prior
      to the pelvic reconstruction.

      Pre-operative evaluation for SUI includes a history and physical exam. The physical exam may
      include an empty supine stress test ESST, standing cough stress test (CST), pyridium pad
      test, and urodynamics (UDS). Prior studies have been performed to determine which of these
      tests are best at identifying SUI. One systemic review found that UDS was 92% sensitive in
      identifying SUI. When comparing UDS to the cough stress test and the weighed pyridium pad
      test, the cough stress test was found to be 90% sensitive and the pyridium pad test only 60%
      sensitive. The pyridium pad test was 68% sensitive when a pad test was found to be positive
      by orange color stain noted on the pad.

      The various ways these tests are performed have also been evaluated. For example, there was
      no statistical difference in outcomes of a CST; whether completed supine or standing and
      independent of bladder volume. In regards to the pyridium pad tests, several studies have
      compared a 1 hour to 24 hour pyridium pad test with varying results of efficacy. Furthermore,
      in a study done when comparing pad weight and color, even asymptomatic women had positive
      pyridium pad tests suggesting this test is less specific in identifying SUI. A secondary
      analysis of the looked at how different reduction methods effect the predictability of
      post-operative SUI on UDS. Reduction of pelvic organ prolapse with a speculum was the most
      sensitive in identifying post-operative SUI at 53%. However, there is a paucity of evidence
      as to which pre-operative test is best in identifying SUI in patients with pelvic organ
      prolapse.

      In this prospective study, the aim is to determine which test is most sensitive in
      pre-operatively identifying SUI and occult SUI in patients treated for prolapse. The
      hypothesis states that there is a difference between the sensitivity of UDS, pyridium pad
      test and cough stress tests, with UDS being the most sensitive and the gold standard in
      identifying SUI in patients with pelvic organ prolapse.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of patients with SUI as per Pelvic Floor Bother Questionnaire prior to prolapse surgery compared to number of patients with clinical SUI identified on either UDS, pyridium pad test and cough stress test.
time frame: 2 years
description: Pelvic Floor Bother Questionnaire:A comparison will be made for each patient across the three studies to identify which test is most predictive of patient's SUI indicated by leakage identified on patients pre-operative questionnaire: Pelvic Floor Bother Questionnaire.
measure: Number of patients with SUI as per the Urogenital Distress Inventory (UDI-6):Questionnaire prior to prolapse surgery compared to number of patients with clinical SUI identified on either UDS, pyridium pad test and cough stress test.
time frame: 2 years
description: The Urogenital Distress Inventory (UDI-6):A comparison will be made for each patient across the three studies to identify which test is most predictive of patient's SUI indicated by leakage identified on patients pre-operative questionnaire: the Urogenital Distress Inventory (UDI-6)
measure: Number of patients with SUI as per The numerical analog scale prior to prolapse surgery compared to number of patients with clinical SUI identified on either UDS, pyridium pad test and cough stress test.
time frame: 2 years
description: The numerical analog scale.A comparison will be made for each patient across the three studies to identify which test is most predictive of patient's SUI indicated by leakage identified on patients pre-operative questionnaire: the numerical analog scale.
arm group label: Urodynamics, pyridium pad & cough stress
arm group type: Other
description: The Pelvic Floor Bother Questionnaire, a questionnaire standardized by Cleveland Clinic Florida, the Urogenital Distress Inventory (UDI-6), and the numerical analog scale are to be administered prior to and 6 weeks after the surgical intervention. (14, 15)
Prior to surgery, patients will be scheduled for a UDS performed by a qualified nurse practitioner or physician and will be given instructions in verbal and written form to undergo a 24 H pyridium pad test at least 72 hours before the UDS. Patients will be given pyridium TID and report if orange stain is noted on their pad in this period of time. A supine and a standing cough stress test will also be performed.
intervention type: Procedure
intervention name: Urodynamics
description: UDS is to be performed with prolapse reduced by a speculum. The patient will be asked to valsalva three times then cough while seated after 150 ml of fluid is instilled in the bladder and then again at 300 ml. The same provocative measures will be performed at capacity, with the catheter in place and without the catheter if no leak is identified. If the patient leaks at any volume or if the patient leaks during the cough pressure profile (CPP), the test will be considered positive. If the patient does not leak during filling nor during the CPP then the test will be considered negative.
arm group label: Urodynamics, pyridium pad & cough stress
other name: 24 hour pyridium pad test
other name: Cough stress test
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Hurtado, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
PMID: 9083302
citation: Latini JM, Kreder KJ Jr. Associated pelvic organ prolapse in women with stress urinary incontinence: when to operate? Curr Opin Urol. 2005 Nov;15(6):380-5. doi: 10.1097/01.mou.0000179760.45715.9b.
PMID: 16205487
citation: Kasturi S, Diaz SI, McDermott CD, Woodman PJ, Bump RC, Terry CL, Hale DS. De novo stress urinary incontinence after negative prolapse reduction stress testing for total vaginal mesh procedures: incidence and risk factors. Am J Obstet Gynecol. 2011 Nov;205(5):487.e1-4. doi: 10.1016/j.ajog.2011.07.006. Epub 2011 Jul 20.
PMID: 21925638
citation: Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
PMID: 22716974
citation: Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. Erratum In: N Engl J Med. 2016 Jun 9;374(23):2297-8.
PMID: 16611949
citation: Martin JL, Williams KS, Abrams KR, Turner DA, Sutton AJ, Chapple C, Assassa RP, Shaw C, Cheater F. Systematic review and evaluation of methods of assessing urinary incontinence. Health Technol Assess. 2006 Feb;10(6):1-132, iii-iv. doi: 10.3310/hta10060.
PMID: 16487456
citation: Price DM, Noblett K. Comparison of the cough stress test and 24-h pad test in the assessment of stress urinary incontinence. Int Urogynecol J. 2012 Apr;23(4):429-33. doi: 10.1007/s00192-011-1602-1. Epub 2011 Nov 16.
PMID: 22086265
citation: Reena C, Kekre AN, Kekre N. Occult stress incontinence in women with pelvic organ prolapse. Int J Gynaecol Obstet. 2007 Apr;97(1):31-4. doi: 10.1016/j.ijgo.2006.12.011. Epub 2007 Feb 8.
PMID: 17291508
citation: W. Henderson, S. Kane, J. Mangel, J. Garibay, E. Kikano, R. Pollard, S. T. Mahajan, A. Hijaz. A randomized comparative study correlating cough stress test with urodynamics and 24 hour pad test in the evaluation of stress urinary incontinence. J. Female Pelvic Medicine & Reconstructive Surgery Issue: September/October 2015. Volume 21(5) Supplement 1, p S11
citation: Artibani, W; Andersen, JT; Gajewski, JB; Ostergard, DR; Raz, S; Tubaro, A; Chapter 8C imaging and other Investigations. 2nd International Consultation on Incontinence 2002 p425-477
citation: Wall LL, Wang K, Robson I, Stanton SL. The Pyridium pad test for diagnosing urinary incontinence. A comparative study of asymptomatic and incontinent women. J Reprod Med. 1990 Jul;35(7):682-4.
PMID: 2198349
citation: Visco AG, Brubaker L, Nygaard I, Richter HE, Cundiff G, Fine P, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):607-14. doi: 10.1007/s00192-007-0498-2. Epub 2008 Jan 9.
PMID: 18185903
citation: Peterson TV, Karp DR, Aguilar VC, Davila GW. Validation of a global pelvic floor symptom bother questionnaire. Int Urogynecol J. 2010 Sep;21(9):1129-35. doi: 10.1007/s00192-010-1148-7. Epub 2010 May 11.
PMID: 20458467
citation: Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
PMID: 7780440
citation: Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
PMID: 19937315
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Eric Hurtado
investigator title: Urogynecology Clinical Fellow
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No
ipd description: Data individual participant data will not be shared with other researches.