Identifying Stress Urinary Incontinence in Women With Pelvic Organ Prolapse



Status:Recruiting
Conditions:Women's Studies, Urology, Urology
Therapuetic Areas:Nephrology / Urology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:9/14/2018
Start Date:February 15, 2017
End Date:December 2018
Contact:Eric Hurtado, MD
Email:HURTADE@ccf.org
Phone:954-659-5559

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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.

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.

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
We found this trial at
1
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Phone: 954-541-4397
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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