Study of Overactive Bladder in Women With Prolapse (SOAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Radboud University
Sponsor:
Collaborators:
Astellas Pharma Inc
Continentie Stichting Nederland (Continence Foundation The Netherlands)
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01540214
First received: February 10, 2012
Last updated: January 4, 2013
Last verified: December 2012

February 10, 2012
January 4, 2013
February 2012
June 2014   (final data collection date for primary outcome measure)
  • The change from baseline in prevalence of OAB as measured by bladder diary and validated disease specific questionnaires at 6 months [ Time Frame: At baseline before surgery and at 6 months after surgery ] [ Designated as safety issue: No ]
  • The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 6 months [ Time Frame: At baseline before surgery and at 6 months after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: At baseline before surgery and at 12 months after surgery ] [ Designated as safety issue: No ]
  • The change from baseline of bothersome OAB symptoms as measured by bladder diary and validated disease specific questionnaires at 12 months [ Time Frame: At baseline before surgery and at 12 months after surgery ] [ Designated as safety issue: No ]
    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).
Same as current
Complete list of historical versions of study NCT01540214 on ClinicalTrials.gov Archive Site
  • Change from baseline in outcomes of urodynamic studies (presence of detrusor overactivity (DO), bladder outflow obstruction (BOO)) at 12 months [ Time Frame: At baseline before surgery and at 12 months after surgery ] [ Designated as safety issue: Yes ]
  • Change from baseline in POP-Q stage at 6 and 12 months [ Time Frame: At baseline before surgery, at 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  • Change from baseline in outcomes of ultrasound assessment (bladder wall thickness, bladder neck descent, retrovesical angle) at 6 and 12 months [ Time Frame: At baseline before surgery, at 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  • Cystoscopic assessment of trabeculation [ Time Frame: At time of surgery ] [ Designated as safety issue: Yes ]
  • Change from baseline in concentration of urinary biomarkers at 12 months [ Time Frame: At baseline before surgery and at 12 months after surgery ] [ Designated as safety issue: No ]
    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 outcomes of urodynamic studies (presence of detrusor overactivity DO, bladder outflow obstruction BOO) at 12 months [ Time Frame: At baseline before surgery and at 12 months after surgery ] [ Designated as safety issue: Yes ]
  • Change from baseline in POP-Q stage at 6 and 12 months [ Time Frame: At baseline before surgery, at 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  • Change from baseline in outcomes of ultrasound assessment (bladder wall thickness, bladder neck descent, retrovesical angle) at 6 and 12 months [ Time Frame: At baseline before surgery, at 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  • Cystoscopic assessment of trabeculation [ Time Frame: At time of surgery ] [ Designated as safety issue: Yes ]
  • Change from baseline in concentration of urinary biomarkers at 12 months [ Time Frame: At baseline before surgery and at 12 months after surgery ] [ Designated as safety issue: No ]
    Concentration of urinary biomarkers: nerve growth factor (NGF), prostaglandin E2 (PGE2) and adenosine triphosphate (ATP) levels in urine normalized against creatinine concentration.
Not Provided
Not Provided
 
Study of Overactive Bladder in Women With Prolapse
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Urine

Probability Sample

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.

  • Urinary Bladder, Overactive
  • Pelvic Organ Prolapse
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.

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
Intervention: Other: Pre- and postoperative evaluations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Myrthe M Tijdink, MD +31-(0)24-3614726 m.tijdink@uro.umcn.nl
Contact: Mark E Vierhout, MD,PhD +31-(0)24-3614726 m.vierhout@obgyn.umcn.nl
Netherlands
 
NCT01540214
2011/456
No
Radboud University
Radboud University
  • Astellas Pharma Inc
  • Continentie Stichting Nederland (Continence Foundation The Netherlands)
Principal Investigator: Mark E Vierhout, MD, PhD Radboud University
Principal Investigator: John PF Heesakkers, MD, PhD Radboud University
Principal Investigator: Myrthe M Tijdink, MD Radboud University
Radboud University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP