Identifying Stress Urinary Incontinence in Women With Pelvic Organ Prolapse

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03005977
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
58.5
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Urodynamics
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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?
Actual Study Start Date :
Feb 15, 2017
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/Treatment
Other: Urodynamics, pyridium pad & cough stress

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.

Procedure: Urodynamics
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.
Other Names:
  • 24 hour pyridium pad test
  • Cough stress test
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [2 years]

      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.

    2. 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. [2 years]

      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)

    3. 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. [2 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 y/o or greater

    • Able to consent

    • Stage 2 or greater prolapse

    • With or without complaint of stress urinary incontinence

    Exclusion Criteria:
    • Desire non-surgical management

    • Prior surgery for prolapse or incontinence

    • Treated medically for incontinence in the past 4 weeks

    • Current Infection

    • Known neurologic condition

    • Stage 3 or greater chronic kidney disease

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Cleveland Clinic FloridaWestonFloridaUnited States33331

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    • Principal Investigator: Eric Hurtado, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Eric Hurtado, Urogynecology Clinical Fellow, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT03005977
    Other Study ID Numbers:
    • FLA 16-078
    First Posted:
    Dec 30, 2016
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eric Hurtado, Urogynecology Clinical Fellow, The Cleveland Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022