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

Primary Purpose

Urge Urinary Incontinence

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
solifenacin
cesa/vasa
Sponsored by
Klinikum der Universität Köln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Urinary Incontinence focused on measuring surgery, solifenacin, urge urinary incontinence

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Abt. Beckenbodenchirugie der Universitäts-Frauenklinik KölnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

solifenacin

cesa/vasa

Arm Description

10 mg solifenacin per day for three months

repair of USL

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2012
Last Updated
April 6, 2015
Sponsor
Klinikum der Universität Köln
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1. Study Identification

Unique Protocol Identification Number
NCT01737411
Brief Title
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
Acronym
URGE-I
Official Title
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum der Universität Köln

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Urinary Incontinence
Keywords
surgery, solifenacin, urge urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
solifenacin
Arm Type
Active Comparator
Arm Description
10 mg solifenacin per day for three months
Arm Title
cesa/vasa
Arm Type
Experimental
Arm Description
repair of USL
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
VESICUR
Intervention Type
Procedure
Intervention Name(s)
cesa/vasa
Intervention Description
surgical repair of USL
Primary Outcome Measure Information:
Title
cure from urge urinary symptoms
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
cure from urge urinary symptoms
Description
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
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
stress incontinence
Description
Some patients develop a stress incontinence after surgical treatment. That is controlled by provocation tests.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfram H Jager, PhD
Phone
0049221478
Ext
4900
Email
wolframjaeger@gmx.de
First Name & Middle Initial & Last Name or Official Title & Degree
Peter S Mallmann, Phd
Phone
0049221478
Ext
4940
Email
peter.mallmann@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfram H Jager, PhD
Organizational Affiliation
Study Supervisor
Official's Role
Study Director
Facility Information:
Facility Name
Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln
City
Köln
State/Province
NRW
ZIP/Postal Code
50931
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfram H Jager
Phone
0049221478
Ext
4900
Email
wolfram.jaeger@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Wolfram H Jager, PhD

12. IPD Sharing Statement

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Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

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