Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa (URGE-II)

April 6, 2015 updated by: Professor Dr. Wolfram Jäger, Klinikum der Universität Köln

Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence

Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Köln, NRW, Germany, 50931
        • Recruiting
        • Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • prior vasa or cesa operation as part of the URGE I study
  • stress urinary incontinence
  • mixed urinary incontinence

Exclusion Criteria:

  • previous urogynecological surgery
  • avulsion of cesa or vasa tape
  • pregnancy
  • neurologic/psychological reasons for incontinence
  • body weight >100kg
  • syndrome of dry overactive bladder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: trans obturatorial tape (TOT)
placement of a sub-urethral tape
Procedure: TOT
Other Names:
  • trans obturatorial tape
Active Comparator: solifenacin
10 mg per day
Drug: solifenacin
Other Names:
  • VESICUR 10mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cure of incontinence
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement of urge symptoms
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum der Universität Köln

Investigators

  • Principal Investigator: Wolfram H Jager, PhD, Study Supervisor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URGE-II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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