Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa

Surgical Treatment of Urge Incontinence Clinical Trial

— URGE-II  

Official title:

Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01737918
• Other study ID #: URGE-II
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 28, 2012
• Last updated: April 6, 2015
• Start date: January 2013
• Est. completion date: July 2018

Study information

• Verified date: April 2015
• Source: Klinikum der Universität Köln
• Contact: Wolfram H Jager, PhD
• Phone: 0049221478
• Email: wolfram.jaeger[@]uk-koeln.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Treatment of Urge Incontinence
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Procedure:
• TOT

Drug:
• solifenacin

Locations

Country	Name	City	State
Germany	Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln	Köln	NRW
Germany	Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln	Köln	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universität Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure of incontinence		3 months	No
Secondary	improvement of urge symptoms		3 months	No