Study of Overactive Bladder in Women With Prolapse

Pelvic Organ Prolapse Clinical Trial

— SOAP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01540214
• Other study ID #: 2011/456
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2012
• Last updated: January 4, 2013
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2012
• Source: Radboud University
• Contact: Myrthe M Tijdink, MD
• Phone: +31-(0)24-3614726
• Email: m.tijdink[@]uro.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Astellas Pharma Inc, Continentie Stichting Nederland (Continence Foundation The Netherlands)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 6 months	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).	At baseline before surgery and at 6 months after surgery	No
Primary	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	No
Primary	The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 12 months	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).	At baseline before surgery and at 12 months after surgery	No
Secondary	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	Yes
Secondary	Change from baseline in POP-Q stage at 6 and 12 months		At baseline before surgery, at 6 and 12 months after surgery	No
Secondary	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	No
Secondary	Cystoscopic assessment of trabeculation		At time of surgery	Yes
Secondary	Change from baseline in concentration of urinary biomarkers at 12 months	Concentration of urinary biomarkers: nerve growth factor (NGF), prostaglandin E2 (PGE2) and adenosine triphosphate (ATP) levels in urine normalized against creatinine concentration.	At baseline before surgery and at 12 months after surgery	No