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

This study has been withdrawn prior to enrollment.
(Difficult to recruit to.)
Sponsor:
Information provided by (Responsible Party):
Elizabeth Mueller, Loyola University
ClinicalTrials.gov Identifier:
NCT02060331
First received: February 10, 2014
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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.


Condition
Nocturia
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Impact of surgical treatment of apical pelvic organ prolapse on bothersome nocturia. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To evaluate whether women with bothersome pre-operative nocturia who undergo surgical treatment for their POP will demonstrate significant symptomatic improvement in nocturia as measured by the NNES-Q questionnaire.


Secondary Outcome Measures:
  • Impact of surgical treatment of apical pelvic organ prolapse on nocturnal polyuria. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To evaluate whether women with bothersome pre-operative nocturia who undergo surgical treatment for their POP will demonstrate a significant post-operative improvement in their nocturnal polyuria based on voiding diaries.

  • Impact of surgical treatment of apical pelvic organ prolapse on urine osmolality parameters. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To evaluate whether women with bothersome pre-operative nocturia who undergo surgical treatment for their POP will demonstrate a significant post-operative improvement in their ability to concentrate urine based on urine osmolality parameters.


Biospecimen Retention:   Samples Without DNA

The awake and asleep renal nocturia urine panels will require the patient to collect her urine output into two laboratory provided basins for one twenty-four hour period. The "renal nocturia, awake" urine panel will be obtained from urine collected from 0600-1800. The "renal nocturia, asleep" urine panel will be obtained from urine collected from 1800-0600, ie through the following day.


Enrollment: 0
Study Start Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pelvic Organ Prolapse with Nocturia
Pelvic Organ Prolapse with Nocturia

Detailed Description:
  1. Significance or Clinical Relevance of Project:

    Numerous women undergo pelvic organ prolapse surgery every year. The most common reasons for surgical management of POP include symptoms immediately related to the prolapsing organs, such as pelvic pressure, vaginal bulge sensation, vaginal mucosal irritation, as well as defecatory dysfunction, limitations on sexual intercourse, and aesthetic dissatisfaction. When counseling patients about possible surgical management of POP, clinicians would be remiss if they did not address the potential quality of life improvement surgery may provide from a urinary standpoint, as well as possible decreased risk of renal failure. Stress and urge incontinence and urinary urgency are frequently alleviated by restoration of the pelvic floor support, however, nocturia may be treated as well.

  2. Relevant Research of Others:

    Several case reports exist describing urinary obstruction, bilateral hydronephrosis, and acute or chronic renal failure that can occur with severe pelvic organ prolapse. No larger scale prospective descriptive studies exist, however, demonstrating the urinary symptoms or pathophysiology behind the urinary tract obstruction that may accompany pelvic organ prolapse. Also, no prospective studies exist to evaluate the improvement in those symptoms and relief of physiologic obstruction after surgical correction of pelvic organ prolapse.

  3. Methods/Materials:

Women referred to the urogynecology clinic for management of apical Stage III-IV POP with bothersome nocturia as noted in their initial urogynecologic evaluation who opt for surgical management will be identified for inclusion in the study. In addition to routine urogynecologic and pre-operative work-up, after consenting for the study, they will be asked to complete pre- and post-operative Nocturia, Nocturnal Enuresis, and Sleep interruption Questionnaires (NNES-Q) (appendix), voiding diaries (appendix), and awake and asleep renal nocturia urine panels. Women will serve as their own pre- and post-operative control subjects.

Enrolled patients will be educated on how to perform the voiding diary and awake and asleep renal nocturia urine panel. The voiding diary will require the patient to measure the date, time, voided urine amount (using a urine hat placed over a toilet), degree of incontinence (dry, moist, soaked), presence or absence of urge to urinate, activity immediately prior to urination episode, and fluid intake for three non-consecutive twenty-four hour periods. The awake and asleep renal nocturia urine panels will require the patient to collect her urine output into two laboratory provided basins for one twenty-four hour period. The "renal nocturia, awake" urine panel will be obtained from urine collected from 0600-1800. The "renal nocturia, asleep" urine panel will be obtained from urine collected from 1800-0600, ie through the following day.

Six to thirteen weeks post-operatively, enrolled patients will be asked to repeat the NNES-Q questionnaire, voiding diary, and awake and asleep renal nocturia urine panels as described above.

Patients who complete all of the aforementioned questionnaires and studies will be reimbursed with a $25 check. This compensation will be disclosed to potential study candidates prior to enrollment in the study.

The data obtained will be de-identified and then entered into SPSS v. 20 software for statistical analysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Ambulatory Urogynecology Clinic

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060331

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Elizabeth Mueller, MD Loyola University Medical Center Department of Urology and Obstetrics
  More Information

Publications:

Responsible Party: Elizabeth Mueller, Principal Investigator, Loyola University
ClinicalTrials.gov Identifier: NCT02060331     History of Changes
Other Study ID Numbers: 206058
Study First Received: February 10, 2014
Last Updated: August 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
Nocturia
Pelvic Organ Prolapse
Nocturnal Polyuria
Post-obstructive Diuresis

Additional relevant MeSH terms:
Nocturia
Pelvic Organ Prolapse
Prolapse
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on November 25, 2014