NCT03463863

Brief Summary

assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2016

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

August 10, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

March 7, 2018

Last Update Submit

March 15, 2018

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • cure rate of stress incontinence

    history and urodynamic study

    one year after surgery

Interventions

rectus sheath midurethral slingPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • stress incontinence

You may not qualify if:

  • overactive bladder

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 13, 2018

Study Start

August 10, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 16, 2018

Record last verified: 2018-03

Locations

EG(1)