Gamma-irradiated amniotic membrane graft as an adjuvant to posterior colporrhaphy: an exploratory prospective single-arm clinical trial.
Rania Hassan Mostafa Ahmed, Mohab Ahmed Fouad ElRabat, Nourhan Ashraf ElSherbiny et al.
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In 30 seconds
This exploratory prospective, single-arm pilot clinical trial evaluated gamma-irradiated amniotic membrane grafting during posterior colporrhaphy in 25 women with posterior compartment prolapse. Symptoms, sexual function, pelvic organ prolapse quantification, and complications were assessed before surgery and at 3 and 6 months. At 6 months, mean POPDI-6 scores fell from 68.00 ± 14.52 to 20.67 ± 7.93, a mean percentage reduction of 68.22% ± 14.54%. Anatomical and sexual-function measures also improved, but vaginitis affected 76% of patients. The uncontrolled design does not establish comparative effectiveness.
Key findings
- Mean POPDI-6 score decreased from 68.00 ± 14.52 at baseline to 20.67 ± 7.93 at 6 months (p < 0.001).
- At 6 months, 80% of patients achieved POP-Q stage 0 and 20% reached stage I.
- Sexual function score increased from 11.75 ± 3.55 to 30.80 ± 2.75.
- Vaginitis affected 76% of patients; no serious complications, including wound dehiscence or visceral injury, were reported.
Why it matters
The findings provide preliminary clinical data on a biological graft used to augment posterior colporrhaphy, including symptom, anatomical, and sexual-function outcomes alongside a frequent postoperative complication. These outcomes may inform further evaluation of the technique, but the small uncontrolled study cannot determine whether the graft improves results over conventional repair.
What to keep in mind
This was a 25-patient, single-arm pilot study with 6-month follow-up and no conventional-colporrhaphy comparator, limiting conclusions about comparative effectiveness and longer-term outcomes.