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

This study is currently recruiting participants.
Verified January 2013 by Klinikum der Universität Köln
Sponsor:
Information provided by (Responsible Party):
Professor Dr. Wolfram Jäger, Klinikum der Universität Köln
ClinicalTrials.gov Identifier:
NCT01737918
First received: November 28, 2012
Last updated: January 20, 2013
Last verified: January 2013

November 28, 2012
January 20, 2013
January 2013
December 2015   (final data collection date for primary outcome measure)
cure of incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01737918 on ClinicalTrials.gov Archive Site
improvement of urge symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Treatment of Urge Incontinence After Repair of the USL
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2016
December 2015   (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
Female
40 Years to 85 Years
No
Contact: Wolfram H Jager, PhD 0049221478 ext 4900 wolfram.jaeger@uk-koeln.de
Contact: Peter Mallmann, PhD 0049221478 ext 4940 peter.mallmann@uk-koeln.de
Germany
 
NCT01737918
URGE II
Yes
Professor Dr. Wolfram Jäger, Klinikum der Universität Köln
Klinikum der Universität Köln
Not Provided
Not Provided
Klinikum der Universität Köln
January 2013

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