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

Sponsor
Klinikum der Universität Köln (Other)
Overall Status
Unknown status
CT.gov ID
NCT01737411
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
65
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. cure from urge urinary symptoms [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

    Secondary Outcome Measures

    1. cure from urge urinary symptoms [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

    Other Outcome Measures

    1. stress incontinence [12 months]

      Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln Köln NRW Germany 50931

    Sponsors and Collaborators

    • Klinikum der Universität Köln

    Investigators

    • Study Director: Wolfram H Jager, PhD, Study Supervisor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Dr. Wolfram Jäger, Professor, Klinikum der Universität Köln
    ClinicalTrials.gov Identifier:
    NCT01737411
    Other Study ID Numbers:
    • URGE-I
    • URGE-I
    • URGE-I
    • 11-016
    First Posted:
    Nov 29, 2012
    Last Update Posted:
    Apr 7, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Professor Dr. Wolfram Jäger, Professor, Klinikum der Universität Köln
    surgery, solifenacin, urge urinary incontinence
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Urge
    Solifenacin Succinate

    Study Results

    No Results Posted as of Apr 7, 2015