Pelvic Organ Prolapse, Urinary Bladder, Overactive
Conditions
Keywords
Urinary Bladder, Overactive, Pelvic Organ Prolapse, Gynecologic Surgical Procedures, Urodynamics
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.
Interventions
OTHERPre- 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.
Sponsors
Astellas Pharma Inc
Continentie Stichting Nederland (Continence Foundation The Netherlands)
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 | — |
| Cystoscopic assessment of trabeculation | At time of surgery | — |
Countries
Netherlands
Contacts
Primary ContactMyrthe M Tijdink, MD
Backup ContactMark E Vierhout, MD,PhD
Outcome results
None listed