NCT01540214

Study of Overactive Bladder in Women With Prolapse

Prevalence of Overactive Bladder (OAB) in Patients With Pelvic Organ Prolapse (POP) and Predictors of Symptoms of OAB After Surgical Correction of POP

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder, Overactive
• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2012-02-28
• Last updated: 2013-01-07

Locations

1 site across 1 country: Netherlands