Objectives
To compare microablative fractional radiofrequency (FMRF), pelvic floor muscle training (PFMT), and their combination (PFMT+FMRF) on vaginal symptoms, quality of life, and sexual function in incontinent climacteric women.
Methods
Secondary outcomes from a prospective, blinded, three-arm randomised controlled trial with 117 women (39 per group), assessed at pre-treatment, one month, and six months using: International Consultation on Incontinence Questionnaire–Vaginal Symptoms (ICIQ-VS), Female Sexual Function Index (FSFI), cytology, Vaginal Health Index (VHI), and transabdominal ultrasound to measure vaginal wall thickness.
Results
All groups showed significant improvement over time in ICIQ-VS total score, laxity, dryness, impact on sex life, abdominal pain, vaginal soreness (p < 0.0001 for all questions), reduced sensation (p = 0.0004), and impairment of sex life (p = 0.0005). Only the FMRF group had sustained improvement in daily life interference at six months (p = 0.0419; CL pre vs post: −63.2 [−94.7;-31.8], pre vs 6 months: −45.7 [−79.4;-12.0]). FSFI improvements (total and domains) were not sustained at six months: total score (0.0102), desire (0.0134), lubrication (0.0093), satisfaction (0.0239), pain (0.0430). VHI showed significant, treatment-dependent differences: for moisture, FMRF improved pre- vs post-treatment (p = 0.0209; CL: 4.5 [2.4;26.6]), FMRF+PFMT improved over time (p = 0.0209; CL: 24.3 [10.6;38.0], 18.6 [4.2;32.9]); for fluid volume, FMRF+PFMT improved (p = 0.0004; CL: 27.6 [12.2;43], 24.7 [8.5;40.8]); for total score, FMRF improved pre- vs post-treatment (p = 0.0028; CL: 13.2 [4.4;22.1]), and FMRF+PFMT improved over time (p = 0.0028; CL: 21.6 [11.7;31.5], 18.9 [8.5;29.3]). All groups improved in pH (p < 0.0001) and epithelial integrity (p < 0.0001); however, the improvement in elasticity (p = 0.0001) was not sustained at six months. Vaginal wall thickness increased similarly across groups.
Conclusion
At six-month follow-up, all groups had similar improvements in quality of life, vaginal health, and sexual function.
Trial registration
This trial is registered on REBEC (Registro Brasileiro de Ensaios Clínicos; Brazilian Registry of Clinical Trials) under number RBR-9v3q33.
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