Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060331
Recruitment Status : Withdrawn (Difficult to recruit to.)
First Posted : February 12, 2014
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Elizabeth Mueller, Loyola University

Tracking Information
First Submitted Date February 10, 2014
First Posted Date February 12, 2014
Last Update Posted Date June 2, 2016
Study Start Date January 2014
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2014)
Impact of surgical treatment of apical pelvic organ prolapse on bothersome nocturia. [ Time Frame: 1 year ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02060331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 11, 2014)
  • Impact of surgical treatment of apical pelvic organ prolapse on nocturnal polyuria. [ Time Frame: 1 year ]
    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 ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study
Official Title Severe Pelvic Organ Prolapse and Post-Obstructive Diuresis (SOPPO) Pilot Study
Brief Summary

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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Probability Sample
Study Population Ambulatory Urogynecology Clinic
Condition
  • Nocturia
  • Pelvic Organ Prolapse
Intervention Not Provided
Study Groups/Cohorts Pelvic Organ Prolapse with Nocturia
Pelvic Organ Prolapse with Nocturia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: August 27, 2014)
0
Original Estimated Enrollment
 (submitted: February 11, 2014)
25
Study Completion Date Not Provided
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02060331
Other Study ID Numbers 206058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Elizabeth Mueller, Loyola University
Study Sponsor Loyola University
Collaborators Not Provided
Investigators
Principal Investigator: Elizabeth Mueller, MD Loyola University Medical Center Department of Urology and Obstetrics
PRS Account Loyola University
Verification Date June 2016