Vaginismus is a hypertonic dysfunction of the pelvic floor musculature, resulting in dyspareunia and compromised sexual health. Standard treatments, including pelvic floor therapy, cognitive-behavioral therapy (CBT), and vaginal dilators, have limited success in severe cases. Botulinum toxin type A (BTX-A) has emerged as a potential neuromodulator for refractory vaginismus, yet robust clinical trials are lacking. This study aims to evaluate the efficacy, neurophysiological impact, and safety of BTX-A injections versus standard therapy in women with severe vaginismus (Lamont Grade 3–4).

This was a prospective, double-blinded, randomized, controlled trial (RCT) conducted across two urogynecology centers. A total of 160 women diagnosed with primary vaginismus (Lamont Grade 3–4) were randomized (1:1) into two arms:
•	Group A (n=80): Received ultrasound-guided BTX-A injections (100 units total) into the bilateral bulbospongiosus, puborectalis, and iliococcygeus muscles.
•	Group B (n=80): Underwent standard therapy, including progressive vaginal dilators, pelvic floor physiotherapy, and CBT.
Primary Endpoints
1.	Pain scores on vaginal penetration (Visual Analog Scale, VAS 0–10)
2.	Female Sexual Function Index (FSFI) score
3.	Success rate (defined as pain-free penetration without involuntary contraction)
Secondary Endpoints
1.	Pelvic floor electromyography (EMG) assessment
2.	Sustained efficacy at 6 months (need for reinjection or additional therapy)
3.	Patient-reported satisfaction and safety profile
Assessments were conducted at baseline, 4 weeks, 3 months, and 6 months post-treatment.

Baseline VAS scores were comparable (Group A: 8.3 ± 1.2 vs. Group B: 8.2 ± 1.1, p=0.63). At 4 weeks, Group A demonstrated a 66% reduction in pain (VAS: 2.8 ± 1.6, p<0.001), compared to 22% in Group B (VAS: 6.4 ± 1.4, p=0.032). By 6 months, 85% of Group A achieved pain-free intercourse, compared to 40% in Group B (p=0.001).
Neurophysiological Findings
•	Pelvic floor EMG activity showed a significant reduction in resting muscle tone post-BTX-A (pre: 18.2 µV ± 2.4, post: 9.6 µV ± 2.1, p<0.001) compared to minimal change in Group B (pre: 18.1 µV ± 2.6, post: 16.9 µV ± 2.5, p=0.08).
•	Muscle hypertonicity decreased by 51% in the BTX group, correlating with VAS pain reduction (r = 0.72, p<0.001).
Safety and Tolerability
•	Transient pelvic floor muscle weakness occurred in 6 patients (7.5%) in Group A, resolving within 3–6 weeks.
•	Mild urinary hesitancy was reported in 4 patients (5%), but no urinary retention occurred.
•	No systemic adverse effects were observed.

This study provides high-level evidence that BTX-A significantly reduces pelvic floor hypertonicity, leading to sustained improvements in pain, sexual function, and penetration tolerance. EMG findings confirm a neuromodulatory effect, supporting BTX-A as a first-line intervention for refractory vaginismus.

Ultrasound-guided botulinum toxin injection is a highly effective, minimally invasive treatment for severe vaginismus, outperforming standard therapy in pain relief, sexual function restoration, and patient satisfaction. Future research should explore optimal dosing strategies, reinjection intervals, and long-term neuromuscular adaptation.