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

This study is currently recruiting participants.
Verified April 2015 by Professor Dr. Wolfram Jäger, Klinikum der Universität Köln
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737411
First Posted: November 29, 2012
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Professor Dr. Wolfram Jäger, Klinikum der Universität Köln
November 27, 2012
November 29, 2012
April 7, 2015
January 2013
December 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01737411 on ClinicalTrials.gov Archive Site
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
Same as current
stress incontinence [ Time Frame: 12 months ]
Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests.
Same as current
 
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urge Urinary Incontinence
  • Drug: solifenacin
    Other Name: VESICUR
  • Procedure: cesa/vasa
    surgical repair of USL
  • Active Comparator: solifenacin
    10 mg solifenacin per day for three months
    Intervention: Drug: solifenacin
  • Experimental: cesa/vasa
    repair of USL
    Intervention: Procedure: cesa/vasa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2018
December 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
40 Years to 80 Years   (Adult, Senior)
No
Contact: Wolfram H Jager, PhD 0049221478 ext 4900 wolframjaeger@gmx.de
Contact: Peter S Mallmann, Phd 0049221478 ext 4940 peter.mallmann@uk-koeln.de
Germany
 
 
NCT01737411
URGE-I
URGE-I ( Other Identifier: OB/GYN )
URGE-I ( Other Identifier: OB/GYN Köln )
11-016 ( Other Identifier: University of Köln )
Yes
Not Provided
Not Provided
Professor Dr. Wolfram Jäger, Klinikum der Universität Köln
Klinikum der Universität Köln
Not Provided
Study Director: Wolfram H Jager, PhD Study Supervisor
Klinikum der Universität Köln
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP