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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01737918
Recruitment Status : Unknown
Verified April 2015 by Professor Dr. Wolfram Jäger, Klinikum der Universität Köln.
Recruitment status was:  Recruiting
First Posted : November 30, 2012
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Professor Dr. Wolfram Jäger, Klinikum der Universität Köln

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Surgical Treatment of Urge Incontinence Procedure: TOT Drug: solifenacin Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. cure of incontinence [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. improvement of urge symptoms [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737918


Contacts
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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
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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
Investigators
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Principal Investigator: Wolfram H Jager, PhD Study Supervisor
More Information
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Responsible Party: Professor Dr. Wolfram Jäger, Professor, Klinikum der Universität Köln
ClinicalTrials.gov Identifier: NCT01737918    
Other Study ID Numbers: URGE-II
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Professor Dr. Wolfram Jäger, Klinikum der Universität Köln:
urge urinary incontinence, cesa, vasa, TOT, solifenacin
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Urological Manifestations
 Behavioral Symptoms
Elimination Disorders
Mental Disorders
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents