ClinicalTrials.gg
Status unknownNCT03473041Updated Mar 21, 2018

Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal

A Phase 3 interventional study of Hybrid sling and TVT-O in Stress Urinary Incontinence, sponsored by sarah mohamed hassan. Status unknown at 1 site in Egypt. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-21.

Sponsored by sarah mohamed hassan · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 39 studies in Urinary Incontinence, Stress with a site in Egypt — 15 open to participants now, 19 under way, none of them phase 3. Urinary Incontinence, Stress · Egypt.

Planned enrollment
3rd of 31
140 · median 60
Started
2018
with 1 other
Phase 3
3 of 39
none open now
Registered
9th of 39
by date
Lead sponsor
2 of 39
sarah mohamed hassan

Among the 39 studies in Urinary Incontinence, Stress with a site in Egypt, this one is the 3rd largest by planned enrollment of the 31 interventional ones that give a count, is one of 2 that started in 2018, is one of 3 in phase 3, and was the 9th registered.

Urinary Incontinence, Stress

653 studies on the registry are indexed under Urinary Incontinence, Stress; 121 are open to participants now.

Browse Urinary Incontinence, Stress studies →

Open to participants now

15 of the 39 studies in Urinary Incontinence, Stress with a site in Egypt are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 74 Urinary Incontinence, Stress studies recruiting now, 42 (57%) set no upper age limit and 18 (24%) stop at 75 or younger; 2 take children under 18; 16 take healthy volunteers.

This study: 25 Years to 65 Years · female · no healthy volunteers.

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02

Study 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)

Read the detailed description

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

03

Conditions studied

  • Stress Urinary Incontinence

Keywords

  • female stress incontinence
  • Transobturator tension free vaginal tape TVTO
04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • stress urinary incontinence

Exclusion criteria

Exclusion Criteria:

  • previous surgery for stress incontinence
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Active comparator
    Hybrid sling

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

    Procedure: Hybrid sling

  • Active comparator
    TVT-O

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

    Procedure: TVT-O

Interventions

  • ProcedureHybrid sling

    sling formed of surgeon tailored autologous rectus sheath and polypropylene arms

  • ProcedureTVT-O

    midurethral transobturator vaginal tape

06

What researchers measure

Primary outcomes

  1. cure rate

    negative cough stress test

    Time frame: 1 year follow up

07

Study locations

1 site
  • Kasr El Ainiy Hospital
    Cairo, 11562, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2018; primary completion for Sep 2019, 18 months later.

Of 14 phase 3 interventional studies under Urinary Incontinence, Stress, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 51. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2018
First posted
Mar 21, 2018
StartEst.
Mar 2018
Primary completionEst.
Sep 2019
CompletionEst.
Sep 2019
Last update
Mar 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03473041
Lead sponsor
sarah mohamed hassan
Responsible party
sarah mohamed hassan (lecturer of obstetrics and gynecology, Kasr El Aini Hospital) — Sponsor-investigator
First posted
Mar 21, 2018
Start date
Mar 2018 (estimated)
Primary completion
Sep 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Mar 21, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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