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Completed

NCT Number: NCT03005977

Identifying Stress Urinary Incontinence in Women With Pelvic Organ Prolapse

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urodynamics

Procedure

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

Primary outcomes

  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.

    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. 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)

  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.

    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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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?

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2016
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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