Botulinum toxin as a Newer Treatment Modality for Vaginismus: A Systematic Review and Meta-analysis

Introduction: Vaginismus, now classified under Genito-Pelvic Pain/Penetration Disorder, is a multifactorial psychosexual condition defined by involuntary pelvic floor muscle contraction, penetration-related fear, avoidance behaviours and substantial psychological distress. First-line management centres on conservative modalities; including cognitive behavioural psychotherapy (CBT), sex therapy, pelvic floor physiotherapy and graded dilator programmes. Botulinum toxin type A (BoNT-A) has emerged as a targeted adjunct, particularly for severe or refractory presentations, by inducing rapid neuromuscular relaxation that facilitates early penetration. A critical evidence gap remains regarding the comparative effectiveness of BoNT-A in vaginismus as a newer treatment modality.

Aims: To compare the effectiveness and safety of BoNT-A injections and psychotherapy (including CBT, sex therapy and multimodal psychological approaches) for the treatment of vaginismus.

Methods: A systematic review and meta-analysis were conducted according to PRISMA 2020 guidelines and the Cochrane Handbook v6.4. Searches were performed in MEDLINE (PubMed), Scopus, Web of Science, CENTRAL, Google Scholar, WHO ICTRP, and ClinicalTrials.gov upto 01 November 2025. Primary outcome is successful vaginal penetration after treatment. Secondary outcomes are Pain scores (VAS), anxiety scores, Female Sexual Function Index (FSFI), treatment satisfaction, recurrence and adverse events. Risk of bias was assessed using the RoB 2 tool and the certainty of evidence was evaluated using GRADE.

Results: Twelve studies (n=826) were included. Overall treatment success was high across modalities, with exposure-based and desensitization protocols demonstrating the strongest outcomes (up to 97.7% intercourse success). CBT produced limited immediate penetration success (14%) but improved broader sexual functioning. BoNT-A demonstrated favourable results in uncontrolled cohorts (75–100% success), although the only direct comparative RCT showed physiotherapy to be superior (92.9% vs 66.7%, P=0.014). Multimodal interventions incorporating counselling and dilation also achieved high success rates.

Conclusion: Psychotherapeutic interventions and BoNT-A are both used in treatment of vaginismus where psychotherapy remains the first-line approach while BoNT-A offers an additional benefit in selected severe or refractory cases.