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

NCT ID: NCT01737918

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Surgical Treatment of Urge Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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trans obturatorial tape (TOT)

placement of a sub-urethral tape

Group Type EXPERIMENTAL

TOT

Intervention Type PROCEDURE

solifenacin

10 mg per day

Group Type ACTIVE_COMPARATOR

solifenacin

Intervention Type DRUG

Interventions

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TOT

Intervention Type PROCEDURE

solifenacin

Intervention Type DRUG

Other Intervention Names

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trans obturatorial tape VESICUR 10mg per day

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Klinikum der Universität Köln

OTHER

Sponsor Role lead

Responsible Party

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Professor Dr. Wolfram Jäger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolfram H Jager, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Supervisor

Locations

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Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Wolfram H Jager, PhD

Role: CONTACT

0049221478 ext. 4900

Peter Mallmann, PhD

Role: CONTACT

0049221478 ext. 4940

Facility Contacts

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Wolfram H Jager, PhD

Role: primary

0049221478 ext. 4900

Wolfram H Jager, PhD

Role: primary

0049221478 ext. 4900

Peter Mallmann, PhD

Role: backup

0049221478 ext. 4940

Other Identifiers

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URGE-II

Identifier Type: -

Identifier Source: org_study_id

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