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NCT02775526 Clinical Trial

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

Treatment Clinical Trial

Official title:
Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02775526
Other study ID # AS1234
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date January 10, 2020

Study information
Verified date January 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date January 10, 2020
Est. primary completion date January 10, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• TOT
70 patients
• TVT
70 patients
• Burch Colposuspension
70 patients

Locations
Country Name City State
Egypt Ain Shams University Maternity Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary objective cure rate 2 years
Primary subjective cure rate 2 years
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