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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
History of Changes
  Purpose

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 Intervention Phase
Treatment of Urge Incontinence After Repair of the USL
 Procedure: TOT
Drug: solifenacin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum der Universität Köln:

Primary Outcome Measures:
  • cure of incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement of urge symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trans obturatorial tape (TOT)
placement of a sub-urethral tape
 Procedure: TOT
Other Name: trans obturatorial tape
Active Comparator: solifenacin
10 mg per day
 Drug: solifenacin
Other Name: VESICUR 10mg per day

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737918

Contacts
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

Locations
Germany
Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln Recruiting
Köln, NRW, Germany, 50931
Contact: Wolfram H Jager, PhD     0049221478 ext 4900     wolfram.jaeger@uk-koeln.de    
Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln Recruiting
Köln, NRW, Germany, 50931
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    
Principal Investigator: Wolfram H Jager, PhD            
Sponsors and Collaborators
Klinikum der Universität Köln
  More Information

No publications provided

Responsible Party: Professor Dr. Wolfram Jäger, Professor, Klinikum der Universität Köln
ClinicalTrials.gov Identifier: NCT01737918     History of Changes
Other Study ID Numbers: URGE II
Study First Received: November 28, 2012
Last Updated: January 20, 2013
Health Authority: Ethical Committee of the University of Köln: Germany

Keywords provided by Klinikum der Universität Köln:
urge urinary incontinence, cesa, vasa, TOT, solifenacin

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
 Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013