Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

Urge Urinary Incontinence Clinical Trial

— URGE-I  

Official title:

Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

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

Related Conditions & MeSH terms

• Urge Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Urge

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