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

NCT ID: NCT02775526

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-01-10

Brief Summary

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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.

Detailed Description

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Conditions

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Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TOT

TOT

Group Type ACTIVE_COMPARATOR

TOT

Intervention Type PROCEDURE

70 patients

TVT

TVT

Group Type ACTIVE_COMPARATOR

TVT

Intervention Type PROCEDURE

70 patients

Burch colposuspension

Burch colposuspension

Group Type ACTIVE_COMPARATOR

Burch Colposuspension

Intervention Type PROCEDURE

70 patients

Interventions

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TOT

70 patients

Intervention Type PROCEDURE

TVT

70 patients

Intervention Type PROCEDURE

Burch Colposuspension

70 patients

Intervention Type PROCEDURE

Other Intervention Names

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Trans-Obturator Tape Tension-Free Vaginal Tape

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AS1234

Identifier Type: -

Identifier Source: org_study_id

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