Clinical trial NCT01540214: Study of Overactive Bladder in Women With Prolapse
Official title: Prevalence of Overactive Bladder (OAB) in Patients With Pelvic Organ Prolapse (POP) and Predictors of Symptoms of OAB After Surgical Correction of POP
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Bladder, Overactive
Pelvic Organ Prolapse
Keywords: Urinary Bladder, Overactive
Pelvic Organ Prolapse
Gynecologic Surgical Procedures
Urodynamics
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
name: Continentie Stichting Nederland (Continence Foundation The Netherlands)
First posted: 2012-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months
timeFrame: At baseline before surgery and at 6 months after surgery
measure: The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 6 months
timeFrame: At baseline before surgery and at 6 months after surgery
measure: The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 12 months
timeFrame: At baseline before surgery and at 12 months after surgery
measure: The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 12 months
timeFrame: At baseline before surgery and at 12 months after surgery
Secondary outcomes:
measure: Change from baseline in outcomes of urodynamic studies (presence of detrusor overactivity (DO), bladder outflow obstruction (BOO)) at 12 months
timeFrame: At baseline before surgery and at 12 months after surgery
measure: Change from baseline in POP-Q stage at 6 and 12 months
timeFrame: At baseline before surgery, at 6 and 12 months after surgery
measure: Change from baseline in outcomes of ultrasound assessment (bladder wall thickness, bladder neck descent, retrovesical angle) at 6 and 12 months
timeFrame: At baseline before surgery, at 6 and 12 months after surgery
measure: Cystoscopic assessment of trabeculation
timeFrame: At time of surgery
measure: Change from baseline in concentration of urinary biomarkers at 12 months
timeFrame: At baseline before surgery and at 12 months after surgery
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Mark E Vierhout, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: John PF Heesakkers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Myrthe M Tijdink, MD
role: PRINCIPAL_INVESTIGATOR
References: