Mixed Urinary Incontinence Surgical Trial | NCT03085979

Studies
Mixed Urinary Incontinence Surgical Trial

NCT03085979

Sponsor

Ain Shams Maternity Hospital

Status

Completed

Last Update Posted

Jul 27, 2022Actual

Enrollment

198Actual

Phase

Not Applicable

Conditions

Med: Urinary Incontinence (Stress, Urge, Mixed)

Interventions

Burch Colposuspension
trans obturator tape
tension free vaginal tape

Countries

Not provided

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

Jul 2022

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

Oct 2014Actual

Primary Completion Date

Oct 2018Actual

Completion Date

May 2022Actual

First Submitted Date

Mar 10, 2017

First Submission Date that Met QC Criteria

Mar 15, 2017

First Posted Date

Mar 22, 2017Actual

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

Jul 26, 2022

Last Update Posted Date

Jul 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Surgical management of mixed urinary incontinence

Detailed Description

Study to evaluate role of anti-incontinent surgery Burch colposuspension Tension free vaginal tape Trans obturator tape for the management of mixed urinary incontinence .

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

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Burch	Experimental	Burch Colposuspension	Procedure: Burch Colposuspension
Trans Obturator Tape	Experimental	Trans Obturator Tape sling	Procedure: trans obturator tape
Tension free vaginal tape	Experimental	Tension free vaginal tape sling	Procedure: tension free vaginal tape

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Burch Colposuspension	Procedure	Anti-incontinent surgery	Burch
trans obturator tape

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cure of Mixed incontinence	compare the 3 groups as regard cure rate of both Components of mixed incontinence	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients 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

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hamdy HA Ahmed Saaid, M.D	Fellow of OBS/GYN	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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

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Browse Branches

Not provided