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

Sponsor
Klinikum der Universität Köln (Other)
Overall Status
Unknown status
CT.gov ID
NCT01737918
Collaborator
(none)
120
Enrollment
2
Locations
2
Arms
65.9
Duration (Months)
60
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Jul 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cure of incontinence [3 months]

    Secondary Outcome Measures

    1. improvement of urge symptoms [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Klinikum der Universität Köln

    Investigators

    • Principal Investigator: 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:
    NCT01737918
    Other Study ID Numbers:
    • URGE-II
    First Posted:
    Nov 30, 2012
    Last Update Posted:
    Apr 7, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Professor Dr. Wolfram Jäger, Professor, Klinikum der Universität Köln
    urge urinary incontinence, cesa, vasa, TOT, solifenacin
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Urge
    Solifenacin Succinate

    Study Results

    No Results Posted as of Apr 7, 2015