Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study

Withdrawn before enrolling

Conditions studied: Nocturia, Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT02060331

Run by

Loyola University

People needed

0

Starts

2014-01-01

Last updated by the study team

2016-06-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female gender
• Bothersome nocturia (presence of ≥1 void per night averaged over 4 weeks with ≥5/10 on 0-10 bother scale)
• Age >18 years
• Apical stage III-IV pelvic organ prolapse as defined by the Pelvic Organ Prolapse Quantification (POP-Q) Staging Criteria: Stage III - leading edge > +1 cm but < +(total vaginal length-2) cm, Stage IV - leading edge ≥ +(tvl-2) cm
• Undergoing surgical correction (colpocleisis, laparoscopic or open sacrocolpopexy, uterosacral ligament suspension, or sacrospinous ligament suspension) for POP by Drs. Mueller, Brincat, and/or Brubaker

You may not qualify if…

• Obstructive sleep apnea (clinically diagnosed on sleep study or patients with excessive daytime sleepiness or nighttime apneic periods as identified by patient or spouse)
• Diuretic use (ie for hypertension)
• Renal insufficiency (Chronic Kidney Disease Stage 3-5, measured or estimated Glomerular Filtration Rate <60) as determined by history and/or serum basic metabolic panel
• Neurogenic detrusor hyperreflexia, detrusor areflexia, detrusor sphincter dyssynergia, chronic urinary catheterization

Where it is running

• Loyola University Medical Center — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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