NCT03085979

Brief Summary

Surgical management of mixed urinary incontinence

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

4 years

First QC Date

March 10, 2017

Last Update Submit

July 26, 2022

Conditions

Med: Urinary Incontinence (Stress, Urge, Mixed)

Outcome Measures

Primary Outcomes (1)

  • cure of Mixed incontinence

    compare the 3 groups as regard cure rate of both Components of mixed incontinence

    1 year

Study Arms (3)

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

Burch ColposuspensionPROCEDURE

Anti-incontinent surgery

Burch
trans obturator tapePROCEDURE

Anti-incontinent surgery

Trans Obturator Tape
tension free vaginal tapePROCEDURE

Anti-incontinent surgery

Tension free vaginal tape

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with Mixed urinary incontinence

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Suburethral Slings

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Hamdy HA Ahmed Saaid, M.D

    Fellow of OBS/GYN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of OBSlGYN

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 22, 2017

Study Start

October 1, 2014

Primary Completion

October 1, 2018

Study Completion

May 1, 2022

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share