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Study of Overactive Bladder in Women With Prolapse

NCT01540214 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2013-01-07

No results posted yet for this study

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.

Conditions

  • Urinary Bladder, Overactive
  • Pelvic Organ Prolapse

Interventions

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.

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Continentie Stichting Nederland (Continence Foundation The Netherlands)

    collaborator UNKNOWN

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Mark E Vierhout, MD, PhD · Radboud University Medical Center

  • John PF Heesakkers, MD, PhD · Radboud University Medical Center

  • Myrthe M Tijdink, MD · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540214 on ClinicalTrials.gov