NCT02775526

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

3.7 years

First QC Date

May 15, 2016

Last Update Submit

January 26, 2020

Conditions

Treatment

Keywords

Mixed urinary incontinenceTransobturator tape (TOT)Tension-Free Vaginal Tape (TVT)Burch colposuspensionUrinary incontinence

Outcome Measures

Primary Outcomes (2)

  • objective cure rate

    2 years

  • subjective cure rate

    2 years

Study Arms (3)

TOT

ACTIVE COMPARATOR

TOT

Procedure: TOT

TVT

ACTIVE COMPARATOR

TVT

Procedure: TVT

Burch colposuspension

ACTIVE COMPARATOR

Burch colposuspension

Procedure: Burch Colposuspension

Interventions

TOTPROCEDURE

70 patients

Also known as: Trans-Obturator Tape
TOT
TVTPROCEDURE

70 patients

Also known as: Tension-Free Vaginal Tape
TVT
Burch ColposuspensionPROCEDURE

70 patients

Burch colposuspension

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women 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

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

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
Dr

Study Record Dates

First Submitted

May 15, 2016

First Posted

May 17, 2016

Study Start

May 1, 2016

Primary Completion

January 10, 2020

Study Completion

January 10, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

EG(1)