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Study of Overactive Bladder in Women With Prolapse (SOAP)

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ClinicalTrials.gov Identifier: NCT01540214
Recruitment Status : Unknown
Verified December 2012 by Radboud University.
Recruitment status was:  Recruiting
First Posted : February 28, 2012
Last Update Posted : January 7, 2013
Sponsor:
Collaborators:
Astellas Pharma Inc
Continentie Stichting Nederland (Continence Foundation The Netherlands)
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment
Urinary Bladder, Overactive Pelvic Organ Prolapse Other: Pre- and postoperative evaluations

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : February 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
    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).

  3. 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 ]
  4. 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 ]
    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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Cystoscopic assessment of trabeculation [ Time Frame: At time of surgery ]
  5. Change from baseline in concentration of urinary biomarkers at 12 months [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Urine


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540214


Contacts
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

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Myrthe M Tijdink, MD    +31-(0)24-3614726    m.tijdink@uro.umcn.nl   
Principal Investigator: Myrthe M Tijdink, MD         
Sponsors and Collaborators
Radboud University
Astellas Pharma Inc
Continentie Stichting Nederland (Continence Foundation The Netherlands)
Investigators
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

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01540214     History of Changes
Other Study ID Numbers: 2011/456
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: December 2012

Keywords provided by Radboud University:
Urinary Bladder, Overactive
Pelvic Organ Prolapse
Gynecologic Surgical Procedures
Urodynamics

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Prolapse
Pelvic Organ Prolapse
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical