ClinicalTrials.gg
CompletedNCT06117670Updated Dec 2, 2025

Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy

A Phase 3 interventional study of posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft in Rectocele; Female and Pelvic Organ Prolapse, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Ain Shams Maternity Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
30 Years to 60 Years
Sex
Female
01

Study 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.

Read the detailed description
  • Methodology:
  1. Protocol approval will be sought from the research ethical committee.
  2. Enrolment: The patients will be recruited from the outpatient gynecology clinic of Ain Shams University Maternity Hospital (ASUMH).
  3. History, examination, and routine investigations will be done to identify eligible patients.

    History taking including (personal history, age, menopausal, medical history, and surgical history), as well as symptoms score using Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) part of the Pelvic Floor Distress Inventory Short Form 20. Also, sexual function will be assessed by Female Sexual Function Index Questionnaire.

    Clinical examination: including (general examination, abdominal examination and pelvic examination and POP-Q.

    Routine investigations: complete blood count and other preoperative tests as needed.

  4. Written informed consent will be sought from the patients after proper counseling.
  5. Surgical procedure:

    Posterior colporrhaphy with application of the amniotic membrane graft will be done as follows:

    Steps of conventional posterior colporrhaphy:

    • A midline incision is extended from the perineal body to the vaginal apex or to the cephalad border of a small or distal rectocele.
    • The Denonvillier's fascia is mobilized from the vaginal epithelium, leaving as much of the tissue as possible attached laterally to the levator fascia.
    • Gamma irradiated Sterilized freeze-dried (lyophilized) amnion grafts will be obtained from the Egyptian Atomic Energy Authority and prepared according to the method of Antounians (2019). Multiple procedures are used to sterilize acellular amniotic membranes, the final of which being gamma irradiation. For tissue allograft sterilisation, gamma radiation is claimed to be the most reliable and successful method. Many tissue banks have employed it to sterilise tissues. The clinical function of the amniotic membrane is unaffected by gamma radiation 11. The most frequent dose for sterilising medical goods is 25 kilogram. This graft has the advantage of complete sterilization and is valid on shelf for 5 years as it is dried. Posterior vaginal wall amniotic membrane graft can be placed on the posterior vaginal wall, between the rectal fascia and the vagina, anchored distally at the uterosacral ligaments, and dorsally at the levator ani muscle. The excess amniotic membrane graft is trimmed off, usually around 1-2 cm on each side.
    • After obvious defects in the rectal muscularis are repaired, the fascia is plicated in the midline with interrupted or continuous sutures using vicryl 0 sutures.
    • When a defective perineal body or perineal membrane is present, reconstruction is performed after accompanying posterior colporrhaphy.
    • The superficial muscles of the perineum and bulbocavernous fascia are plicated in the midline and the skin closed as in an episiotomy repair using vicryl 2/0 sutures.
    • Detachments of the inferior portion of the Denonvillier's fascia from the perineal body are also corrected.

    Postoperative instructions and care:

    • Vaginal pack will be left as a compression and will be removed the following day.
    • Urinary catheter: will be left for 24hours then removed.
    • Postoperative clinical assessment by POP-Q.
    • Patients will be instructed to:
    • Mobilize to reduce risk of deep vein thrombosis.
    • Bath or shower as normal routine.
    • Avoid using tampons for 6 weeks.
    • Avoid sexual intercourse for at least 6weeks.
    • Avoid constipation; by drinking plenty of water and fluids, eating fruit and green vegetables, and any constant cough is to be treated promptly.
    • Avoid heavy lifting to reduce the risk of the prolapse recurrence.
  6. Follow up schedule:

    Follow up of all patients will be done in both groups at 3 and 6 months (symptoms +/- examination as needed).

  7. Data collection and recording. Data will be collected and recorded in case report form. Detection bias will be avoided by blinding the outcome assessor.
  8. Statistical analysis will be done to get the results.
02

Conditions studied

  • Rectocele; Female
  • Pelvic Organ Prolapse

Keywords

  • pelvic organ prolapse
  • sexual satisfaction
  • POP-Q
03

In context

Rectocele

50 studies on the registry are indexed under Rectocele; 9 are open to participants now.

This study's enrollment of 25 is below the median of 62 across 37 interventional studies indexed under Rectocele.

Browse Rectocele studies →

Lead sponsor

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

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

04

Who can participate

Ages eligible
30 Years to 60 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

  • 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.
  • 20-35 kg/m2
  • Planned for surgical correction

Exclusion criteria

Exclusion Criteria:

  • Patients with:
  • Immuno-compromise e.g. Patients receiving chemotherapy, .
  • Severe anaemia (\<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.,.
  • Uncontrolled medical disorders (diabetes, hypertension, asthma).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    amniotic membrane graft

    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

  • Combination productposterior colporrhaphy using gamma-irradiated amniotic membrane as a graft

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

06

What researchers measure

Primary outcomes

  1. POP-Q

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

    Time frame: first week postoperative

  2. 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.

    Time frame: at 3 months, and at 6 months postoperative

Secondary outcomes

  1. sexual satisfaction

    to measure sexual satisfaction using female sexual function index questionnaire The Female Sexual Function Index (FSFI) was developed to assess six domains of female sexual function (sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain). Items are scored on a five-point Likert scale with low scores indicating lower levels of sexual functioning. Fifteen items also include a zero score as a sixth response option indicating no sexual activity in the past 4 weeks. Range: 2 to 36.

    Time frame: at 3 months, and at 6 months postoperative

  2. wound complications

    Wound infection or wound dehiscence as detected clinically and /or CRP and vaginal swab as needed

    Time frame: within 6 months postoperative

  3. Intraoperative complications

    occurrence of intraoperative bladder or bowel injury

    Time frame: Intraoperative

07

Study locations

1 site
  • Ain Shams Maternity Hospital
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — We plan to share the results, and the analytic code after publication of the study manuscript after the study has completed

Supporting information: 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)

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2023 to primary completion in Jan 2025, 14 months.

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

Registered
Oct 31, 2023
First posted
Nov 7, 2023
StartActual
Nov 1, 2023
Primary completionActual
Jan 5, 2025
CompletionActual
Aug 5, 2025
Last update
Dec 2, 2025
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 Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06117670
Responsible party
Rania Hassan Mostafa (Dr, Ain Shams Maternity Hospital) — Principal investigator
First posted
Nov 7, 2023
Start date
Nov 1, 2023
Primary completion
Jan 5, 2025
Completion
Aug 5, 2025
Last update
Dec 2, 2025

Study contacts

Ihab FS Eldin Allam, MD
study chair · Ain Shams University
Ahmed M Abbas, MD
study director · Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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