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Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa (URGE-II)

Primary Purpose

Surgical Treatment of Urge Incontinence

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

About this trial

This is an interventional treatment trial for Surgical Treatment of Urge Incontinence focused on measuring urge urinary incontinence, cesa, vasa, TOT, solifenacin

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • prior vasa or cesa operation as part of the URGE I study
  • stress urinary incontinence
  • mixed urinary incontinence

Exclusion Criteria:

  • previous urogynecological surgery
  • avulsion of cesa or vasa tape
  • pregnancy
  • neurologic/psychological reasons for incontinence
  • body weight >100kg
  • syndrome of dry overactive bladder

Sites / Locations

  • Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik KölnRecruiting
  • Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik KölnRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

trans obturatorial tape (TOT)

solifenacin

Arm Description

placement of a sub-urethral tape

10 mg per day

Outcomes

Primary Outcome Measures

cure of incontinence

Secondary Outcome Measures

improvement of urge symptoms

Full Information

First Posted
November 28, 2012
Last Updated
April 6, 2015
Sponsor
Klinikum der Universität Köln
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1. Study Identification

Unique Protocol Identification Number
NCT01737918
Brief Title
Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa
Acronym
URGE-II
Official Title
Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence
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
July 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
Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.
Detailed Description
It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Treatment of Urge Incontinence
Keywords
urge urinary incontinence, cesa, vasa, TOT, solifenacin

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
trans obturatorial tape (TOT)
Arm Type
Experimental
Arm Description
placement of a sub-urethral tape
Arm Title
solifenacin
Arm Type
Active Comparator
Arm Description
10 mg per day
Intervention Type
Procedure
Intervention Name(s)
TOT
Other Intervention Name(s)
trans obturatorial tape
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
VESICUR 10mg per day
Primary Outcome Measure Information:
Title
cure of incontinence
Time Frame
3 months
Secondary Outcome Measure Information:
Title
improvement of urge symptoms
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: prior vasa or cesa operation as part of the URGE I study stress urinary incontinence mixed urinary incontinence Exclusion Criteria: previous urogynecological surgery avulsion of cesa or vasa tape pregnancy neurologic/psychological reasons for incontinence body weight >100kg syndrome of dry overactive bladder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfram H Jager, PhD
Phone
0049221478
Ext
4900
Email
wolfram.jaeger@uk-koeln.de
First Name & Middle Initial & Last Name or Official Title & Degree
Peter 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
Principal Investigator
Facility Information:
Facility Name
Abt. Beckenbodenchirurgie 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, PhD
Phone
0049221478
Ext
4900
Email
wolfram.jaeger@uk-koeln.de
Facility Name
Abt. Beckenbodenchirurgie 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, PhD
Phone
0049221478
Ext
4900
Email
wolfram.jaeger@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Peter Mallmann, PhD
Phone
0049221478
Ext
4940
Email
peter.mallmann@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Wolfram H Jager, PhD

12. IPD Sharing Statement

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Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa

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