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

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. Identifier: NCT01737918
Recruitment Status : Recruiting
First Posted : November 30, 2012
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
Professor Dr. Wolfram Jäger, Klinikum der Universität Köln

November 28, 2012
November 30, 2012
April 7, 2015
January 2013
December 2017   (Final data collection date for primary outcome measure)
cure of incontinence [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT01737918 on Archive Site
improvement of urge symptoms [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa
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.
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.
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Surgical Treatment of Urge Incontinence
  • Procedure: TOT
    Other Name: trans obturatorial tape
  • Drug: solifenacin
    Other Name: VESICUR 10mg per day
  • Experimental: trans obturatorial tape (TOT)
    placement of a sub-urethral tape
    Intervention: Procedure: TOT
  • Active Comparator: solifenacin
    10 mg per day
    Intervention: Drug: solifenacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
40 Years to 85 Years   (Adult, Older Adult)
Contact: Wolfram H Jager, PhD 0049221478 ext 4900
Contact: Peter Mallmann, PhD 0049221478 ext 4940
Not Provided
Not Provided
Professor Dr. Wolfram Jäger, Klinikum der Universität Köln
Klinikum der Universität Köln
Not Provided
Principal Investigator: 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