in women with genital prolapse Overactive bladder symptoms in women with pelvic organ prolapse - Frequent and strong desire to void with or without urinary incontinence
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Female patients, age 18 or greater, with a pelvic organ prolapse POP-Q stage II to IV . - Patient will undergo prolapse repair surgery. - Patient understands the Dutch written and spoken language.
Exclusion criteria
Exclusion criteria: - Patients who currently use anticholinergic medication. - Patients with neurological causes of OAB. - Patients who are pregnant or wish to become pregnant. - Patients with a history of cancer in the pelvic region, treated with radiotherapy or surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are the presence of bothersome OAB as measured by bladder diary and validated disease specific questionnaires (UDI, IIQ, ICIQ-FLUTS, OABSS) and the outcomes of urodynamic studies (presence of detrusor overactivity (DO), bladder outflow obstruction (BOO)). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are the outcomes of measurement of POP-Q, ultrasound assesment of bladder wall thickness (BWT) and configuration of urethra and bladder neck, analysis of urinary biomarkers, and the findings of cystoscopy (presence of trabeculation). | — |
Countries
Netherlands