ArticleBMC women's health2026
Gamma-irradiated amniotic membrane graft as an adjuvant to posterior colporrhaphy: an exploratory prospective single-arm clinical trial.
Article in BMC women's health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06117670 (Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial), which is not on this map. Not yet cited in PubMed.
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Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial
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6 authors.
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Abstract
backgroundPosterior compartment prolapse is a frequent pelvic floor disorder. While conventional posterior colporrhaphy is widely used, the recurrence rates and limitations in terms of tissue support remain concerns. Human amniotic membrane represents a promising biological scaffold with potent regenerative properties. This study aimed to evaluate the feasibility, safety and effectiveness of using amniotic membrane as a graft in posterior colporrhaphy.
methodsThis pilot one-arm clinical trial was conducted on women with posterior compartment prolapse at Ain Shams University Hospital during the period (November 2023- August 2025). Twenty-five patients underwent posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft on the rectovaginal septum. We assessed symptoms score via the Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), sexual function via the Female Sexual Function Index Questionnaire, and pelvic organ prolapse quantification (POP-Q) preoperatively, and at 3 and 6 months post-operatively, and assessed complication rates.
resultsThe AM graft was successfully implanted in all patients. The overall procedure was associated with reduction in POPDI-6 scores from 68.00 ± 14.52 at baseline to 20.67 ± 7.93 at 6 months (p < 0.001), with a mean percentage reduction of 68.22% ± 14.54%. The sexual function score improved from 11.75 ± 3.55 to 30.80 ± 2.75. Anatomical assessment revealed that 80% of patients achieved POP-Q stage 0, whereas 20% reached stage I by 6 months. No serious complications (wound dehiscence, visceral injury) were reported; however, vaginitis was common, affecting 76% of patients.
conclusionPosterior colporrhaphy with adjuvant gamma-irradiated amniotic membrane graft was associated with some improvement in symptoms, clinical examination, as well as sexual function of the patients. However, this is a one-arm pilot study; further studies are needed to compare this technique with conventional colporrhaphy.
trial registrationClinicaltrials.gov NCT06117670, on 31/10/2023.
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