TOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence

Ain Shams University

Status: Completed

Conditions: Treatment

Treatments: Procedure: TOT; Procedure: Burch Colposuspension; Procedure: TVT

Study type: Interventional

Funder types: Other

Identifiers

NCT02775526

AS1234

Details and patient eligibility

About

This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.

Enrollment: 220 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with mixed urinary incontinence.

Exclusion criteria

• Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
• Women who improved on medical treatment with persistence of stress element only were also excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

TOT

Active Comparator group

Description:

TOT

Treatment:

Procedure: TOT

TVT

Active Comparator group

Description:

TVT

Treatment:

Procedure: TVT

Burch colposuspension

Active Comparator group

Description:

Burch colposuspension

Treatment:

Procedure: Burch Colposuspension