Rectocele; FemalePhase 3NCT06117670
Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy
A Phase 3 study testing posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft in people with Rectocele; Female and Pelvic Organ Prolapse, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Rectocele; Female, Pelvic Organ Prolapse
- What is being tested?
- posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 5 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial
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:
- Protocol approval will be sought from the research ethical committee.
- Enrolment: The patients will be recruited from the outpatient gynecology clinic of Ain Shams University Maternity Hospital (ASUMH).
- 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.
- Written informed consent will be sought from the patients after proper counseling.
- 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.
- Follow up schedule: Follow up of all patients will be done in both groups at 3 and 6 months (symptoms +/- examination as needed).
- Data collection and recording. Data will be collected and recorded in case report form. Detection bias will be avoided by blinding the outcome assessor.
- Statistical analysis will be done to get the results.
- Conditions
- Rectocele; Female, Pelvic Organ Prolapse
- Being tested
- posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft
- Keywords
- pelvic organ prolapse, sexual satisfaction, POP-Q
- Medical subject headings
- Rectocele, Pelvic Organ Prolapse, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior colporrhaphy using gamma-irradiated amniotic membrane as a graftCombination product
Posterior colporrhaphy with application of the gamma-irradiated amniotic membrane graft will be done
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
POP-Q
Prolapse assessment using the prolapse quantification system of the International Continence Society (POP-Q)
Measured: 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.
Measured: at 3 months, and at 6 months postoperative
Secondary outcomes (3)
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.
Measured: at 3 months, and at 6 months postoperative
wound complications
Wound infection or wound dehiscence as detected clinically and /or CRP and vaginal swab as needed
Measured: within 6 months postoperative
Intraoperative complications
occurrence of intraoperative bladder or bowel injury
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023
- Primary completion5 Jan 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectocele; FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients will undergo posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Mostafa, Ain Shams Maternity Hospital
- Investigators
- Ihab FS Eldin Allam, MD, Study chair, Ain Shams UniversityAhmed M Abbas, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117670
- Sponsor's protocol ID
- FMASU MD81/2023
- Status last verified
- Dec 2025
- First submitted
- 31 Oct 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the results, and the analytic code after publication of the study manuscript after the study has completed
Publications
Ahmed RHM, ElRabat MAF, ElSherbiny NA, Allam IFSE, Hakim AHA, Sadek AMA. Gamma-irradiated amniotic membrane graft as an adjuvant to posterior colporrhaphy: an exploratory prospective single-arm clinical trial. BMC Womens Health. 2026 Oct 17;26(1):532. doi: 10.1186/s12905-026-04919-9.
PubMed 42892673
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT06117670
- Acronym / sponsor ID
- FMASU MD81/2023
- Conditions
- Rectocele; Female, Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, sexual satisfaction, POP-Q
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Methodology:
- Protocol approval will be sought from the research ethical committee.
- Enrolment: The patients will be recruited from the outpatient gynecology clinic of Ain Shams University Maternity Hospital (ASUMH).
- 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.
- Written informed consent will be sought from the patients after proper counseling.
- 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.
- Follow up schedule: Follow up of all patients will be done in both groups at 3 and 6 months (symptoms +/- examination as needed).
- Data collection and recording. Data will be collected and recorded in case report form. Detection bias will be avoided by blinding the outcome assessor.
- Statistical analysis will be done to get the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients will undergo posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft
| Arm | Type | Receives |
|---|---|---|
| amniotic membrane graft | Experimental | Combination Product: posterior colporrhaphy using gamma-irradiated amniotic membrane as a graftwomen 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterior colporrhaphy using gamma-irradiated amniotic membrane as a graftPosterior colporrhaphy with application of the gamma-irradiated amniotic membrane graft will be done | Combination product | amniotic membrane graft |
Primary outcome
POP-Q
Time frame: first week postoperative
Prolapse assessment using the prolapse quantification system of the International Continence Society (POP-Q)
POPDI-6 score
Time frame: at 3 months, and at 6 months postoperative
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.
3 secondary outcomes
sexual satisfaction
Time frame: at 3 months, and at 6 months postoperative
wound complications
Time frame: within 6 months postoperative
Intraoperative complications
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 42892673Ahmed RHM, ElRabat MAF, ElSherbiny NA, Allam IFSE, Hakim AHA, Sadek AMA. Gamma-irradiated amniotic membrane graft as an adjuvant to posterior colporrhaphy: an exploratory prospective single-arm clinical trial. BMC Womens Health. 2026 Oct 17;26(1):532. doi: 10.1186/s12905-026-04919-9.
- Individual participant dataSharing planned: Yes. We plan to share the results, and the analytic code after publication of the study manuscript after the study has completed
Related trials for Rectocele; Female
Recruiting
Transanal vs Transvaginal Rectal Resection for Anterior Rectocele
Rectocele; Female
Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Vaginal Vault Prolapse, Uterine Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihab FS Eldin Allam, MD study chair
Ain Shams University
Ahmed M Abbas, MD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft in people with Rectocele; Female and Pelvic Organ Prolapse, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POP-Q (time frame: first week postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06117670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.