Treatment of Urge Urinary Incontinence in Women After Fai... | NCT01737918

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

NCT01737918

Sponsor

Klinikum der Universität Köln

Status

Unknown status

Last Update Posted

Apr 7, 2015Estimated

Enrollment

120Estimated

Phase

Phase 1Phase 2

Conditions

Surgical Treatment of Urge Incontinence

Interventions

TOT
solifenacin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2017Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Nov 28, 2012

First Submission Date that Met QC Criteria

Nov 28, 2012

First Posted Date

Nov 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Dr. Wolfram Jäger, Professor, Klinikum der Universität KölnPrincipal Investigator

Lead Sponsor

Klinikum der Universität KölnOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
trans obturatorial tape (TOT)	Experimental	placement of a sub-urethral tape	Procedure: TOT
solifenacin	Active Comparator	10 mg per day	Drug: solifenacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TOT	Procedure		trans obturatorial tape (TOT)	trans obturatorial tape
solifenacin

Measure	Description	Time Frame
cure of incontinence		3 months

Measure	Description	Time Frame
improvement of urge symptoms		3 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wolfram H Jager, PhD	Contact	0049221478	4900	wolfram.jaeger@uk-koeln.de
Peter Mallmann, PhD	Contact	0049221478	4940	peter.mallmann@uk-koeln.de

Overall Officials

Name	Affiliation	Role
Wolfram H Jager, PhD	Study Supervisor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln	Recruiting	Cologne	North Rhine-Westphalia	50931	Germany

Condition Browse Module

MeSH Terms

ID	Term
D053202	Urinary Incontinence, Urge

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069464	Solifenacin Succinate

Ancestor Terms

ID	Term
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D006571	Heterocyclic Compounds
D044005	Tetrahydroisoquinolines

Browse Leaves

Not provided

Browse Branches

Not provided