Study of Overactive Bladder in Women With Prolapse (SOAP)

Radboud University Medical Center

Status: Unknown

Conditions: Urinary Bladder, Overactive; Pelvic Organ Prolapse

Treatments: Other: Pre- and postoperative evaluations

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01540214

2011/456

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

POP surgery

Description:

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

Treatment:

Other: Pre- and postoperative evaluations