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
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:
Participants will undergo posterior colporrhaphy, which will be modified by adding gamma-irradiated amniotic membrane as a graft during the repair.
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.
Surgical procedure:
Posterior colporrhaphy with application of the amniotic membrane graft will be done as follows:
Steps of conventional posterior colporrhaphy:
Postoperative instructions and care:
Follow up schedule:
Follow up of all patients will be done in both groups at 3 and 6 months (symptoms +/- examination as needed).
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 →Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
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).
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Posterior colporrhaphy with application of the gamma-irradiated amniotic membrane graft will be done
POP-Q
Prolapse assessment using the prolapse quantification system of the International Continence Society (POP-Q)
Time frame: 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.
Time frame: at 3 months, and at 6 months postoperative
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
wound complications
Wound infection or wound dehiscence as detected clinically and /or CRP and vaginal swab as needed
Time frame: within 6 months postoperative
Intraoperative complications
occurrence of intraoperative bladder or bowel injury
Time frame: Intraoperative
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.
Ran from Nov 2023 to primary completion in Jan 2025, 14 months.
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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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