TOT, TVT And Burch Colpo-Suspension for Treatment of Fema... | NCT02775526

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

NCT02775526

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 28, 2020Actual

Enrollment

220Actual

Phase

Not Applicable

Conditions

Treatment

Interventions

TOT
TVT
Burch Colposuspension

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jan 10, 2020Actual

Completion Date

Jan 10, 2020Actual

First Submitted Date

May 15, 2016

First Submission Date that Met QC Criteria

May 16, 2016

First Posted Date

May 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2020

Last Update Posted Date

Jan 28, 2020Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TOT	Active Comparator	TOT	Procedure: TOT
TVT	Active Comparator	TVT	Procedure: TVT
Burch colposuspension	Active Comparator	Burch colposuspension	Procedure: Burch Colposuspension

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TOT	Procedure	70 patients	TOT	Trans-Obturator Tape

Measure	Description	Time Frame
objective cure rate		2 years
subjective cure rate		2 years

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Maternity Hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053825	Suburethral Slings

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided