BMC women's health · 2026
Gamma-irradiated amniotic membrane graft as an adjuvant to posterior colporrhaphy: an exploratory prospective single-arm clinical trial.
Clinical StudyСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Ahmed Rania Hassan Mostafa, ElRabat Mohab Ahmed Fouad, ElSherbiny Nourhan Ashraf, Allam Ihab Fouad Serag Eldin, Hakim Ahmed Hesham Abdel, Sadek Ahmed Mohamed Abbas
Аннотация
BACKGROUND: Posterior 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.
METHODS: This 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.
RESULTS: The 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.
CONCLUSION: Posterior 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 REGISTRATION: Clinicaltrials.gov NCT06117670, on 31/10/2023.
METHODS: This 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.
RESULTS: The 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.
CONCLUSION: Posterior 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 REGISTRATION: Clinicaltrials.gov NCT06117670, on 31/10/2023.