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New graft shows promise for vaginal wall repair

NCT ID NCT06117670

Disease control Sponsor: Ain Shams Maternity Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using a gamma-irradiated amniotic membrane as a graft during surgical repair of the back vaginal wall helps women with rectocele (a type of pelvic organ prolapse). Twenty-five women aged 30-60 underwent the surgery. The approach aimed to improve prolapse severity and symptoms, and results showed benefits in prolapse assessment and symptom scores.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

25 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 60 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women diagnosed as posterior vaginal wall prolapse: bulging of front wall of rectum into the vagina due to weakening of pelvic support system and thinning of rectovaginal septum. * Women aged 30-60 years. * BMI 20-35 kg/m2 * Planned for surgical correction Exclusion Criteria: * Patients with: * Immuno-compromise e.g. Patients receiving chemotherapy, steroids. * Severe anaemia (Hb\<10) * conditions that require concomitant reconstructive pelvic floor surgery e.g., anterior and/or apical compartment prolapse. * Conditions that lead to increase intra-abdominal pressure e.g.,chronic obstructive pulmonary disease. * Uncontrolled medical disorders (diabetes, hypertension, asthma).

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Conditions

The condition(s) this trial relates to.

Orgasm pelvic organ prolapse prolapse of female genital organ Rectocele

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pelvic organ prolapse Rectocele; female

Contacts and locations

Locations

  • Ain Shams Maternity Hospital

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.