Study of Overactive Bladder in Women With Prolapse

• Conditions: Urinary Bladder, Overactive; Pelvic Organ Prolapse
• Interventions: Other: Pre- and postoperative evaluations

• Registration Number: NCT01540214
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-28
• Status Verified: 2012-12
• Last Update Submitted: 2013-01-04
• Last Update Posted: 2013-01-07
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POP surgery	Pre- and postoperative evaluations	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

Primary Outcome Measures

Name	Time	Method
The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months	At baseline before surgery and at 6 months after surgery
The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 6 months	At baseline before surgery and at 6 months after surgery	The bother of OAB symptoms, measured by validated disease specific questionnaires, will be presented by scores that reflect the degree of severity of the voiding dysfunction. The presence of bothersome OAB symptoms will be dichotomized in patients with symptoms and moderate to severe bother (symptomatic) and patients with absence of symptoms or with only little or no bother (asymptomatic).
The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 12 months	At baseline before surgery and at 12 months after surgery	The bother of OAB symptoms, measured by validated disease specific questionnaires, will be presented by scores that reflect the degree of severity of the voiding dysfunction. The presence of bothersome OAB symptoms will be dichotomized in patients with symptoms and moderate to severe bother (symptomatic) and patients with absence of symptoms or with only little or no bother (asymptomatic).
The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 12 months	At baseline before surgery and at 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Cystoscopic assessment of trabeculation	At time of surgery
Change from baseline in outcomes of urodynamic studies (presence of detrusor overactivity (DO), bladder outflow obstruction (BOO)) at 12 months	At baseline before surgery and at 12 months after surgery
Change from baseline in outcomes of ultrasound assessment (bladder wall thickness, bladder neck descent, retrovesical angle) at 6 and 12 months	At baseline before surgery, at 6 and 12 months after surgery
Change from baseline in POP-Q stage at 6 and 12 months	At baseline before surgery, at 6 and 12 months after surgery
Change from baseline in concentration of urinary biomarkers at 12 months	At baseline before surgery and at 12 months after surgery	Concentration of urinary biomarkers: nerve growth factor (NGF), prostaglandin E2 (PGE2) and adenosine triphosphate (ATP) levels in urine normalized against creatinine concentration.

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands