CompletedNCT03489902Updated Apr 9, 2018

Transvaginal Versus Transobturator Paravaginal Repair

An interventional study of Transobturator Paravaginal Repair and traditional transvaginal Paravaginal Repair in Cystocele, sponsored by Ain Shams Maternity Hospital. Completed. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-04-09.

Sponsored by Ain Shams Maternity Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year 2 months after the study started (first participant enrolled Jan 2017, registered Mar 2018).

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Non-randomized
Ages: 20 Years to 50 Years
Sex: Female

Study summary

Clinical trial comparing the new technique for paravaginal repair versus the traditional technique

Read the detailed description

trial comparing the transobturator paravaginal repair versus the traditional technique

Conditions studied

Cystocele

Browse trials for

Cystocele 71

In context

Cystocele

71 studies on the registry are indexed under Cystocele; 5 are open to participants now.

This study's enrollment of 40 is below the median of 75 across 46 interventional studies indexed under Cystocele.

Browse Cystocele studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.

Browse Ain Shams Maternity Hospital studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 50 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

paravaginal defect cystocele

midline and paravaginal defect cystocele

Exclusion criteria

Exclusion Criteria:

uterine descent previous cystocele surgery

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 40 participants (actual)

Study arms

Experimental
Transobturator arm
Transobturator Paravaginal Repair
Procedure: Transobturator Paravaginal Repair
Experimental
Transvaginal arm
traditional transvaginal Paravaginal Repair
Procedure: traditional transvaginal Paravaginal Repair

Interventions

ProcedureTransobturator Paravaginal Repair
Transobturator application of sutures to the white line in cases needing paravaginal repair
Proceduretraditional transvaginal Paravaginal Repair
traditional transvaginal application of sutures to the white line

What researchers measure

Primary outcomes

Operative data
Operative time
Time frame: 1 day

Secondary outcomes

Pelvic organ prolapse quantification system
Evaluation of the postoperative degree of anterior vaginal wall descent
Time frame: 3 month
Operative Details
blood loss
Time frame: 1 day

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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

Ran from Jan 2017 to primary completion in Dec 2017, 11 months.

Of 19 interventional studies with no phase under Cystocele, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 76. This study's 11 months is below that.

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

Registered: Mar 28, 2018
First posted: Apr 6, 2018
StartActual: Jan 1, 2017
Primary completionActual: Dec 31, 2017
CompletionActual: Mar 1, 2018
Last update: Apr 9, 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 Apr 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03489902
Lead sponsor: Ain Shams Maternity Hospital
Responsible party: Hamdy Ahmed Saaid (Fellow of obstetrics & gynecology, Ain Shams Maternity Hospital) — Principal investigator
First posted: Apr 6, 2018
Start date: Jan 1, 2017
Primary completion: Dec 31, 2017
Completion: Mar 1, 2018
Last update: Apr 9, 2018

Study contacts

Hamdy HA Saaid, MD

principal investigator · Ain Shams University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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