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

Klinikum der Universität Köln

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Surgical Treatment of Urge Incontinence

Treatments: Procedure: TOT; Drug: solifenacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01737918

URGE-II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 40 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

trans obturatorial tape (TOT)

Experimental group

Description:

placement of a sub-urethral tape

Treatment:

Procedure: TOT

solifenacin

Active Comparator group

Description:

10 mg per day

Treatment:

Drug: solifenacin