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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02775526
Enrollment
220
Registered
2016-05-17
Start date
2016-05-31
Completion date
2020-01-10
Last updated
2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment

Keywords

Mixed urinary incontinence, Transobturator tape (TOT), Tension-Free Vaginal Tape (TVT), Burch colposuspension, Urinary incontinence

Brief 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.

Interventions

PROCEDURETOT

70 patients

PROCEDURETVT

70 patients

70 patients

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
objective cure rate2 years
subjective cure rate2 years

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026