Study of Overactive Bladder in Women With Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-12-31

Brief Summary

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Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are present in approximately 50% of patients with POP. For many women the accompanying symptoms of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with dissatisfaction with the final results of an operation for POP.

The primary aim of this research project is to investigate the difference in prevalence (i.e. improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair surgery. The secondary objectives are to determine changes in bladder function at 6 and 12 months after surgery and to identify predictive factors for persistence, disappearance or de novo symptoms of OAB after POP surgery.

Women who present with POP and who will undergo surgical treatment will be evaluated at baseline before their surgery and will be followed for the duration of one year after surgery.

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Detailed Description

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Conditions

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Urinary Bladder, Overactive Pelvic Organ Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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POP surgery

All women who present with POP at the outpatient clinic of our centre and who will undergo prolapse repair surgery will be asked informed consent for participation in this study

Pre- and postoperative evaluations

Intervention Type OTHER

At baseline before surgery and at 6 and 12 months after surgery: questionnaires, bladder diary, pelvic examination with additional ultrasound (one extra outpatient clinic visit at 6 months compared to standard care).

At baseline before surgery and at 12 months after surgery: urodynamics with additional urine sampling (one extra outpatient clinic visit at 12 months compared to standard care).

At time of surgery: additional cystoscopy.

Interventions

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Pre- and postoperative evaluations

At baseline before surgery and at 6 and 12 months after surgery: questionnaires, bladder diary, pelvic examination with additional ultrasound (one extra outpatient clinic visit at 6 months compared to standard care).

At baseline before surgery and at 12 months after surgery: urodynamics with additional urine sampling (one extra outpatient clinic visit at 12 months compared to standard care).

At time of surgery: additional cystoscopy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female patients, age 18 or greater, with a pelvic organ prolapse stage II to IV as defined by the POP-Q system
* Patient is a candidate for prolapse repair surgery (as based on history and physical examination)
* Patient is capable to fill out bladder diaries and questionnaires and understands the Dutch written and spoken language

Exclusion Criteria

* Patients who currently use anticholinergic medication
* Patients with neurological causes of OAB
* Patients who are pregnant
* Patients with a history of cancer in the pelvic region, treated with radiotherapy or surgery

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No