NCT03473041

Brief Summary

a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

March 15, 2018

Last Update Submit

March 20, 2018

Conditions

Stress Urinary Incontinence

Keywords

female stress incontinenceTransobturator tension free vaginal tape TVTO

Outcome Measures

Primary Outcomes (1)

  • cure rate

    negative cough stress test

    1 year follow up

Study Arms (2)

Hybrid sling

ACTIVE COMPARATOR

70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling

Procedure: Hybrid sling

TVT-O

ACTIVE COMPARATOR

70 patients with stress urinary incontinence treated with conventional TVT-O

Procedure: TVT-O

Interventions

Hybrid slingPROCEDURE

sling formed of surgeon tailored autologous rectus sheath and polypropylene arms

Hybrid sling
TVT-OPROCEDURE

midurethral transobturator vaginal tape

TVT-O

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stress urinary incontinence

You may not qualify if:

  • previous surgery for stress incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 21, 2018

Study Start

March 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

EG(1)