Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women (URGE I)

This study is currently recruiting participants. (see Contacts and Locations)
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:
NCT01737411
First received: November 27, 2012
Last updated: January 20, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.


Condition Intervention Phase
Urge Urinary Incontinence
Drug: solifenacin
Procedure: cesa/vasa
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

Resource links provided by NLM:


Further study details as provided by Klinikum der Universität Köln:

Primary Outcome Measures:
  • cure from urge urinary symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At the start of the study urge symptoms are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment


Secondary Outcome Measures:
  • cure from urge urinary symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    When the assigned first line treatment did not cure patients receive the treatment of the other arm (cross-over). Before cross-over urge symptoms of each patient are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment


Other Outcome Measures:
  • stress incontinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests.


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: solifenacin
10 mg solifenacin per day for three months
Drug: solifenacin
Other Name: VESICUR
Experimental: cesa/vasa
repair of USL
Procedure: cesa/vasa
surgical repair of USL

Detailed Description:

Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin.

We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients.

In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group.

Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • urge urinary incontinence

Exclusion Criteria:

  • stress urinary incontinence
  • cancer disease of the females genital tract
  • pregnancy
  • neurologic/psychological reasons for incontinence
  • body weight >100kg
  • previous urogynecological surgery (TVT)
  • syndrome of dry overactive bladder (>20 micturitions within 24 hours)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737411

Contacts
Contact: Wolfram H Jager, PhD 0049221478 ext 4900 wolframjaeger@gmx.de
Contact: Peter S Mallmann, Phd 0049221478 ext 4940 peter.mallmann@uk-koeln.de

Locations
Germany
Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln Recruiting
Köln, NRW, Germany, 50931
Contact: Wolfram H Jager    0049221478 ext 4900    wolfram.jaeger@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: NCT01737411     History of Changes
Other Study ID Numbers: URGE I, URGE I, URGE I, 11-016
Study First Received: November 27, 2012
Last Updated: January 20, 2013
Health Authority: Germany: Ethics Committee

Keywords provided by Klinikum der Universität Köln:
surgery, solifenacin, urge urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014