Hypothesis / aims of study
McIndoe vaginoplasty remains a standard surgical technique for the management of vaginal agenesis, particularly in patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome and androgen insensitivity syndrome (AIS). The choice of graft material plays a crucial role in determining anatomical and functional outcomes (1). Human placental amniotic membrane or amnion has been widely used due to its biological compatibility and epithelialization potential (2); however, its availability and handling limitations have prompted exploration of alternatives. Oxidised regenerated cellulose (ORC) is a readily available, absorbable material with favourable surgical properties (3). Aim of the study was to compare human placental amniotic membrane and oxidised regenerated cellulose (ORC) as graft material to cover vaginal mould after McIndoes vaginoplasty in terms of sexual function and anatomical outcome.
Study design, materials and methods
This was a case-control pilot study included patients aged >18 years diagnosed with vaginal agenesis due to MRKH syndrome or AIS, who had either failed non-surgical management or declined it, and were sexually active or planned sexual activity within 3–6 months postoperatively. Patients with previous failed vaginoplasty or those unwilling to participate were excluded. Baseline evaluation included presenting complaints, vaginal length, associated renal and pelvic anomalies, and Female Sexual Function Index (FSFI) scoring in sexually active individuals. Patients were allocated in a 1:1 ratio to undergo McIndoe vaginoplasty using either amnion (control group) or ORC (study group) as graft material applied over a vaginal mould. Functional outcomes were evaluated using FSFI scores at 6 months. Other outcomes were anatomical success assessed by measuring vaginal length intraoperatively and at 3 and 6 months postoperatively. Vaginal epithelialization was assessed by cytology and vaginal biopsy at 6 months in consenting patients. The primary outcome measure was the functional outcome measured in terms of FSFI score. Other outcome measures were anatomical success in terms of vaginal length, epithelialization patterns on cytology and histopathology.
Results
A total of 30 patients were enrolled, with 15 patients in each group. The mean age was comparable between the amnion and ORC groups (22.75 ± 4.39 vs 24.57 ± 4.64 years; p=0.31). The majority of patients had MRKH syndrome (29/30), with one case of complete AIS. All were known cases of vaginal agenesis and came for neovaginal creation for sexual activity. Follow-up was completed in 12 patients in the amnion group and 14 patients in the ORC group. Mean vaginal length was similar between groups after surgery (8.16 ± 0.15 cm vs 8.14 ± 0.43 cm; p=0.90), at 3 months (6.19 ± 1.16 cm vs 6.19 ± 1.90 cm; p=0.25), and at 6 months (6.8 ± 1.13 cm vs 5.8 ± 1.38 cm; p=0.06) in the amnion and ORC groups, respectively. At 6 months, 75% (9/12) of patients in the amnion group and 85.7% (12/14) in the ORC group were sexually active. The mean FSFI scores were comparable between groups (30.44 ± 1.00 vs 28.94 ± 4.68; p=0.32). Cytological evaluation at 6 months, available in 7 patients in both the groups, demonstrated similar epithelial maturation, with basal and parabasal cells observed in 85.7% and 71.4% of cases in the amnion and ORC groups, respectively (p=0.5). Vaginal biopsy performed in four consenting patients (two in each group) revealed stratified squamous epithelium in all cases.
Interpretation of results
Oxidised regenerated cellulose is equivalent to human placental amniotic membrane graft to cover vaginal mould in terms of functional and anatomical outcome of surgery after McIndoe vaginoplasty done for complete vaginal agenesis.