Pelvic magnetic stimulation added to pelvic-floor muscle training for female vaginal laxity: a randomized controlled trial

To evaluate the short-term efficacy of pelvic magnetic stimulation combined with pelvic floor rehabilitation training (Intervention) versus isolated pelvic floor muscle training (PFMT) among women diagnosed with vaginal laxity (Population). The Vaginal Laxity Questionnaire (VLQ) total score assessed at 8 weeks of treatment was predefined as the primary outcome (Outcome), and multiple subjective and objective indicators were adopted as secondary outcomes to comprehensively reflect pelvic floor function recovery. A total of 147 patients diagnosed with vaginal laxity at the Department of Obstetrics and Gynecology, Qinghai Red Cross Hospital—either during outpatient visits or hospitalization—from March 2025 to October 2025 and meeting the inclusion criteria were enrolled. After providing informed consent, all participants were randomly assigned using a random number table into two groups: the control group (n = 73) receiving PFMT alone, and the combined-intervention group (n = 74) receiving the combined intervention. Both groups underwent an 8-week treatment regimen, with a treatment log established for each participant. Assessments were conducted at three predefined time points, evaluating the following eight outcome measures: VLQ, female sexual function, degree of vaginal laxity, vaginal health index score(VHIS), pelvic floor type I and type II muscle fibers, surface electromyography (sEMG) of the pelvic floor muscles, three-dimensional ultrasound parameters, and mean vaginal pressure. The primary outcome (8-week VLQ total score) was significantly higher in the combined-intervention group compared with the control group at both 4-week and 8-week follow-ups (both P < 0.001). However, although the primary analysis employed cross-sectional between-group comparisons at each timepoint rather than a formal group × time interaction test, a supplementary linear mixed-effects model with group × time interaction was performed as a sensitivity analysis and confirmed significant differential change trajectories between groups (Group × Time interaction: F = 29.587, P < 0.001 for VLQ; F = 495.662, P < 0.001 for FSFI total score). All secondary subjective indicators including total Female Sexual Function Index (FSFI) and its six subdomains, vaginal laxity finger grading, type I/II pelvic floor muscle fiber strength and fatigue resistance showed significantly superior improvements in the combined-intervention group ( P < 0.05). For objective imaging and functional metrics, most 3D pelvic floor ultrasound parameters and vaginal resting/cough/defecation pressure values were significantly better in the combined-intervention group at week 8 ( P < 0.05). No intergroup statistical differences were detected in vaginal health index (VHIS) total score, post-contraction resting-phase sEMG value, resting bladder neck initial position and levator-urethra gap(LUG) at either follow-up time point ( P > 0.05). These preliminary findings suggest that combined pelvic magnetic stimulation and PFMT may improve vaginal laxity and sexual function compared with PFMT alone. Results require confirmation in multicenter, sham-controlled trials with longer follow-up. Trial registration : Chinese Clinical Trial Registry (ChiCTR2600122143); registered on April 9, 2026.