Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy

NCT06117670 | Completed Phase 3 DMC

• 1 other identifier: FMASU MD81/2023
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the benefit of using gamma-irradiated amniotic membrane as a graft in surgical repair for women with posterior vaginal wall defects. The main question it aims to answer is: • Is posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft effective? Participants will undergo posterior colporrhaphy, which will be modified by adding gamma-irradiated amniotic membrane as a graft during the repair.

Conditions

Rectocele; Female; Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; sexual satisfaction; POP-Q

Outcome Measures

Primary Outcomes (2)

• POP-Q

  Prolapse assessment using the prolapse quantification system of the International Continence Society (POP-Q)

  first week postoperative

• POPDI-6 score

  Assessment of symptoms score using Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) part of the Pelvic Floor Distress Inventory Short Form 20. Scale from 0 to 100, the higher score indicates worse condition.

  at 3 months, and at 6 months postoperative

Secondary Outcomes (3)

• sexual satisfaction

  at 3 months, and at 6 months postoperative

• wound complications

  within 6 months postoperative

• Intraoperative complications

  Intraoperative

Study Arms (1)

amniotic membrane graft

EXPERIMENTAL

women with posterior vaginal prolapse will be enrolled and posterior colporrhaphy will be done with the application of sterilized (gamma irradiated) amniotic membrane as a graft.

Combination Product: posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft

Interventions

posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft COMBINATION_PRODUCT

Posterior colporrhaphy with application of the gamma-irradiated amniotic membrane graft will be done

amniotic membrane graft

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Rectocele; Pelvic Organ Prolapse; Orgasm

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Prolapse; Sexual Behavior; Behavior

Study Officials

• Ihab FS Eldin Allam, MD

  Ain Shams University

  STUDY CHAIR

• Ahmed M Abbas, MD

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: patients will undergo posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: January 5, 2025
• Study Completion: August 5, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be available after publication, for 10years.
• Access Criteria: data will be sent via e-mail upon reasonable request (raneyah@med.asu.edu.eg)

Locations

EG (1)