Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
NCT ID: NCT01737411
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2013-01-31
2018-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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solifenacin
10 mg solifenacin per day for three months
solifenacin
cesa/vasa
repair of USL
cesa/vasa
surgical repair of USL
Interventions
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solifenacin
cesa/vasa
surgical repair of USL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
40 Years
80 Years
FEMALE
No
Sponsors
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Klinikum der Universität Köln
OTHER
Responsible Party
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Professor Dr. Wolfram Jäger
Professor
Principal Investigators
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Wolfram H Jager, PhD
Role: STUDY_DIRECTOR
Study Supervisor
Locations
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Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln
Cologne, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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URGE-I
Identifier Type: OTHER
Identifier Source: secondary_id
URGE-I
Identifier Type: OTHER
Identifier Source: secondary_id
11-016
Identifier Type: OTHER
Identifier Source: secondary_id
URGE-I
Identifier Type: -
Identifier Source: org_study_id
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