Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women (URGE-I)

April 6, 2015 updated by: Professor Dr. Wolfram Jäger, Klinikum der Universität Köln
The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin.

We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients.

In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group.

Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).

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. Beckenbodenchirugie der Universitäts-Frauenklinik Köln
        • 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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • urge urinary incontinence

Exclusion Criteria:

  • stress urinary incontinence
  • cancer disease of the females genital tract
  • pregnancy
  • neurologic/psychological reasons for incontinence
  • body weight >100kg
  • previous urogynecological surgery (TVT)
  • syndrome of dry overactive bladder (>20 micturitions within 24 hours)

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: solifenacin
10 mg solifenacin per day for three months
Drug: solifenacin
Other Names:
  • VESICUR
EXPERIMENTAL: cesa/vasa
repair of USL
Procedure: cesa/vasa
surgical repair of USL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure from urge urinary symptoms
Time Frame: 12 months
At the start of the study urge symptoms are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure from urge urinary symptoms
Time Frame: 12 months
When the assigned first line treatment did not cure patients receive the treatment of the other arm (cross-over). Before cross-over urge symptoms of each patient are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress incontinence
Time Frame: 12 months
Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests.
12 months

Collaborators and Investigators

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

Sponsor

Klinikum der Universität Köln

Investigators

  • Study Director: 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)

June 1, 2018

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (ESTIMATE)

November 29, 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-I (OTHER: OB/GYN Köln)
  • 11-016 (University of Köln)

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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