Effectiveness of radiofrequency therapy combined with pelvic floor muscle training in breast cancer survivors with genitourinary syndrome of menopause: a study protocol.

[AIM] To evaluate the effectiveness of non-ablative radiofrequency therapy combined with pelvic floor muscle training (PFMT) compared with sham radiofrequency therapy plus PFMT in improving symptoms associated with genitourinary syndrome of menopause (GSM) in breast cancer survivors.

[METHODS] A randomized, single-blind, parallel-group clinical trial is currently underway. The participants and outcome assessors are blinded to group allocation. Participants have been, and are still being, recruited from oncology, gynaecology and rehabilitation services, and assigned at random to the experimental group (non-ablative radiofrequency therapy plus PFMT) or the placebo group (sham radiofrequency therapy plus PFMT). The intervention lasts for 6 weeks, with one session per week. Following this period, participants continue with a home-based PFMT programme for an additional 3 months without supervision. The outcomes are assessed at baseline, immediately after the intervention, and at 3-month follow-up. The primary outcome is the reduction of vaginal dryness (measured with the Numeric Rating Scale). Secondary outcomes include symptoms of vulvovaginal atrophy (e.g. dyspareunia, burning, itching), urinary symptoms, Vaginal Health Index score, vaginal pH, sexual function (assessed with the Female Sexual Function Index), pelvic floor muscle strength, vaginal morphology (assessed with the Pelvic Organ Prolapse Quantification system), and patient satisfaction. Adherence to PFMT protocols and adverse events will also be recorded.

[CONCLUSIONS] The results of this trial are expected to provide preliminary data on the short-term effects and feasibility of non-ablative radiofrequency therapy combined with PFMT as a non-invasive therapeutic option for GSM in breast cancer survivors.