Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal

NCT ID: NCT03473041

Last Updated: 2018-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2019-09-30

Brief Summary

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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)

Detailed Description

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a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling

Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hybrid sling

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

Group Type ACTIVE_COMPARATOR

Hybrid sling

Intervention Type PROCEDURE

sling formed of surgeon tailored autologous rectus sheath and polypropylene arms

TVT-O

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

Group Type ACTIVE_COMPARATOR

TVT-O

Intervention Type PROCEDURE

midurethral transobturator vaginal tape

Interventions

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Hybrid sling

sling formed of surgeon tailored autologous rectus sheath and polypropylene arms

Intervention Type PROCEDURE

TVT-O

midurethral transobturator vaginal tape

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* stress urinary incontinence

Exclusion Criteria

* previous surgery for stress incontinence
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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sarah mohamed hassan

OTHER

Sponsor Role lead

Responsible Party

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sarah mohamed hassan

lecturer of obstetrics and gynecology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kasr El Ainiy Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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783

Identifier Type: -

Identifier Source: org_study_id

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