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Botulinum toxin-A is ineffective in premature ejaculation treatment: insights from a meta-analysis of randomised controlled trials

International Journal of Impotence Research volume 37, pages 881–888 (2025)Cite this article

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Abstract

The ejaculatory reflex consists of emission and expulsion, with the latter involving rhythmic muscular contractions that propel seminal fluid. Botulinum toxin, through its inhibitory effects, has been hypothesized to improve premature ejaculation (PE). This study evaluates high-quality evidence on botulinum toxin-A injections into the bulbospongiosal muscle as a treatment for PE. We conducted a systematic review and meta-analysis of randomised-controlled trials (RCTs) following PRISMA guidelines. Outcomes included intravaginal ejaculatory latency time (IELT), Premature Ejaculation Profile (PEP) scores, and complications. Data were analysed using Microsoft Excel and R. ROB-2, Eggers test, and GRADE assessed risk of bias, publication bias, and certainty of evidence (CoE). Three RCTs were eligible, and covered data from 228 patients with (1:1) randomisation into intervention and control arms (100 units of botulinum toxin-A in 10 mLs versus 10 mLs of 0.9% NaCl). IELT increases were noted with averages of 39.6, 11.5, and 2.4 s at 1, 3, and 6 months of follow up, respectively. Likewise, PEP scores demonstrated improvements of 1.54, 1.08, and 0.36 units at the same follow up intervals. however, statistical significance was not achieved in both outcomes of interest. Post-procedural complications were recorded in 11 patients (9.6%) with 10 in the intervention group. The majority of patients had voiding difficulties (n = 5) & mild erectile dysfunction (n = 4), however, all adverse events (AEs) were self-resolving and did not require active treatment. Given our findings, current high-quality evidence does not support using Botulinum Toxin-A in the management of PE. Larger scale & standardised RCTs are recommended to conclusively outline its clinical benefits.

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Fig. 1: PRISMA flowchart.
Fig. 2: IELT changes.
Fig. 3: PEP scores.
Fig. 4: Adverse events.
Fig. 5: Traffic light plot.

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The original contributions presented in the study are included & referenced in the article. Further inquiries can be directed to the corresponding author.

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Author information

Authors and Affiliations

  1. Health Education England North East Deanery, Newcastle upon Tyne, UK

    Mohamed Mubarak

  2. Government Hospital, Manama, Kingdom of Bahrain

    Qasim Isa

  3. Manchester University Hospitals NHS Foundation Trust, Manchester, UK

    Vaibhav Modgil & Ian Pearce

Authors
  1. Mohamed Mubarak
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  2. Qasim Isa
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  3. Vaibhav Modgil
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  4. Ian Pearce
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Contributions

MM: Study Conception and Design, Data Collection and Analysis, Manuscript Writing and Editing. QI: Study Conception and Design, Data Collection, Manuscript Writing. VB: Supervision, Manuscript Writing and Editing, Approval of Final Version. IP: Supervision, Manuscript Writing and Editing, Approval of Final Version.

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Correspondence to Mohamed Mubarak.

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Ethical approval was not applicable for this project as there were no patients involved directly. The data retrieved, utilised and synthesized is already available in publicly accessible publications.

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Mubarak, M., Isa, Q., Modgil, V. et al. Botulinum toxin-A is ineffective in premature ejaculation treatment: insights from a meta-analysis of randomised controlled trials. Int J Impot Res 37, 881–888 (2025). https://doi.org/10.1038/s41443-025-01022-9

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