Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
URGE-I
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedApril 7, 2015
April 1, 2015
4.9 years
November 27, 2012
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
cure from urge urinary symptoms
12 months
Other Outcomes (1)
stress incontinence
12 months
Study Arms (2)
solifenacin
ACTIVE COMPARATOR10 mg solifenacin per day for three months
cesa/vasa
EXPERIMENTALrepair of USL
Interventions
Eligibility Criteria
You may qualify if:
- urge urinary incontinence
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln
Cologne, North Rhine-Westphalia, 50931, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wolfram H Jager, PhD
Study Supervisor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 27, 2012
First Posted
November 29, 2012
Study Start
January 1, 2013
Primary Completion
December 1, 2017
Study Completion
June 1, 2018
Last Updated
April 7, 2015
Record last verified: 2015-04