Identifying Stress Urinary Incontinence in Women With Pelvic Organ Prolapse

April 6, 2022 updated by: Eric Hurtado, The Cleveland Clinic

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 years
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
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)
2 years
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
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLA 16-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data individual participant data will not be shared with other researches.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pelvic Organ Prolapse

Clinical Trials on Urodynamics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe