Study of Overactive Bladder in Women With Prolapse (SOAP)

Prevalence of Overactive Bladder (OAB) in Patients With Pelvic Organ Prolapse (POP) and Predictors of Symptoms of OAB After Surgical Correction of POP

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Bladder, Overactive; Pelvic Organ Prolapse
• Intervention / Treatment: Other: Pre- and postoperative evaluations

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Myrthe M Tijdink, MD; Phone Number: +31-(0)24-3614726; Email: m.tijdink@uro.umcn.nl
• Study Contact Backup: Name: Mark E Vierhout, MD,PhD; Phone Number: +31-(0)24-3614726; Email: m.vierhout@obgyn.umcn.nl

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Recruiting
    • Radboud University Nijmegen Medical Centre
    • Contact: Myrthe M Tijdink, MD; Phone Number: +31-(0)24-3614726; Email: m.tijdink@uro.umcn.nl
    • Principal Investigator: Myrthe M Tijdink, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

POP surgery; 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Astellas Pharma Inc; Continentie Stichting Nederland (Continence Foundation The Netherlands)
• Investigators: Principal Investigator: Mark E Vierhout, MD, PhD, Radboud University Medical Center; Principal Investigator: John PF Heesakkers, MD, PhD, Radboud University Medical Center; Principal Investigator: Myrthe M Tijdink, MD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 28, 2012

Study Record Updates

• Last Update Posted (Estimate): January 7, 2013
• Last Update Submitted That Met QC Criteria: January 4, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Urodynamics; Pelvic Organ Prolapse; Urinary Bladder, Overactive; Gynecologic Surgical Procedures
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Anatomical; Urinary Bladder, Overactive; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 2011/456