NCT01737918

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

4.9 years

First QC Date

November 28, 2012

Last Update Submit

April 6, 2015

Conditions

Surgical Treatment of Urge Incontinence

Keywords

urge urinary incontinence, cesa, vasa, TOT, solifenacin

Outcome Measures

Primary Outcomes (1)

  • cure of incontinence

    3 months

Secondary Outcomes (1)

  • improvement of urge symptoms

    3 months

Study Arms (2)

trans obturatorial tape (TOT)

EXPERIMENTAL

placement of a sub-urethral tape

Procedure: TOT

solifenacin

ACTIVE COMPARATOR

10 mg per day

Drug: solifenacin

Interventions

TOTPROCEDURE
Also known as: trans obturatorial tape
trans obturatorial tape (TOT)
solifenacinDRUG
Also known as: VESICUR 10mg per day
solifenacin

Eligibility Criteria

Age40 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln

Cologne, North Rhine-Westphalia, 50931, Germany

RECRUITING

Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln

Cologne, North Rhine-Westphalia, 50931, Germany

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Wolfram H Jager, PhD

    Study Supervisor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfram H Jager, PhD

CONTACT

0049221478wolfram.jaeger@uk-koeln.de

Peter Mallmann, PhD

CONTACT

0049221478peter.mallmann@uk-koeln.de

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 28, 2012

First Posted

November 30, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

DE(2)