Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study
Public ClinicalTrials.gov record NCT02060331. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In our experience, women with severe pelvic organ prolapse (POP) frequently have bothersome nocturia. The International Continence Society (ICS) defines nocturia as "having to wake at night one or more times to void." Though some of this nocturia may be secondary to obstructed bladder emptying, the investigators hypothesize that in some women compression of the bilateral ureters due to prolapsed pelvic organs during the day and subsequent relief of that prolapse while the patient lays supine overnight results in nighttime post-obstructive diuresis (inability to concentrate urine) and resultant large nighttime urine volumes and nocturia. Previous case reports have proposed that vaginal and uterine vault prolapse causes obstruction due to descent of the bladder floor which leads to compression of the bilateral ureters between the uterus and the borders of the genital opening. No large prospective studies, however, have evaluated the possible impact of this phenomenon on patients or the possible post-operative changes following surgical correction of POP. Using the Nocturnal Enuresis, and Sleep interruption Questionnaire (NNES-Q), voiding diaries, and urine studies, the investigators aim to evaluate the pre-operative and post-operative voiding habits and urinary parameters of women with severe pelvic organ prolapse and bothersome nocturia who undergo colpocleisis. Colpocleisis is a procedure which surgically obliterates the vaginal lumen to treat severe POP in properly counseled patients with \>90% satisfaction rates. Other treatments offered to women, such as the laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, and sacrospinous ligament suspension, also offer high rates of success. The investigators aim to determine whether surgical correction of severe pelvic organ prolapse, to be defined as either with colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension, results in improvement and/or resolution of nocturia and post-obstructive diuresis.
Study identification
- NCT ID
- NCT02060331
- Recruitment status
- Withdrawn
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2013
- Primary completion
- Dec 31, 2013
- Completion
- Not listed
- Last update posted
- Jun 1, 2016
Started 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02060331, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 1, 2016 · Synced Sep 8, 2026
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The complete protocol, eligibility criteria, and contact information for NCT02060331 live on ClinicalTrials.gov.