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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01737411
Other study ID # URGE-I
Secondary ID URGE-IURGE-I11-0
Status Recruiting
Phase Phase 1/Phase 2
First received November 27, 2012
Last updated April 6, 2015
Start date January 2013
Est. completion date June 2018

Study information

Verified date April 2015
Source Klinikum der Universität Köln
Contact Wolfram H Jager, PhD
Phone 0049221478
Email wolframjaeger@gmx.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 80 Years
Eligibility 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)

Study Design

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


Intervention

Drug:
solifenacin

Procedure:
cesa/vasa
surgical repair of USL

Locations

Country Name City State
Germany Abt. Beckenbodenchirugie 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
Other stress incontinence Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests. 12 months No
Primary cure from urge urinary symptoms 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 12 months No
Secondary cure from urge urinary symptoms 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 12 months No
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