Efficacy of Botulinum Toxin Injections for Erectile Dysfunction and Premature Ejaculation: A Meta-Analysis of Randomized Controlled Trials

Background:: Male sexual dysfunction, with specific reference to erectile malfunction and premature ejaculation, interferes with both physical and social health of individuals. Erectile dysfunction is seen as the inability to obtain a construction that is rigid enough for successful sexual intercourse, while premature ejaculation is defined as the premature discharge that triggers discomfort. Botulinum toxin, a neurotoxin that blocks acetylcholine release, is thought to lower SMH tone and alter neurotransmitter substrates presumed to be involved in these disorders. Here, we present a systematic review and metaanalysis to determine the efficacy of Botulinum toxin injections in the treatment of erectile dysfunction and premature ejaculation. Methods:: A comprehensive literature review was executed across various databases, including PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, and Scopus, to identify relevant randomized controlled trials evaluating the efficacy of botulinum toxin injections for sexual dysfunction disorders. Subsequently, a meticulous extraction of pertinent information was performed, followed by the extraction of outcomes of interest. A meta-analysis was conducted employing a random effects model using RevMan software. Results:: This systematic review and meta-analysis included eight clinical trials (n = 742 patients) evaluating the efficacy of botulinum toxin (BoTN) in sexual dysfunction. For premature ejaculation, BoTN significantly increased intravaginal ejaculatory latency time (IELT) compared to control (MD = 17.63 seconds, 95% CI [6.69, 28.57], p = 0.02). In erectile dysfunction, BoTN demonstrated significant improvements in the Sexual Health Inventory for Men (SHIM) score at both 2 weeks (MD = 3.25 points, 95% CI [1.10, 5.40], p = 0.03) and 3 months (MD = 5.30 points, 95% CI [2.60, 8.00], p = 0.0001). Discussion:: Botulinum toxin (BoTN) demonstrates significant therapeutic potential for treating both premature ejaculation, by effectively increasing ejaculatory latency, and erectile dysfunction, by improving key indicators like erection hardness and penile blood flow. Its novel mechanism, which involves relaxing hypertonic smooth muscle and modulating peripheral neurotransmission, offers a valuable approach for patients who do not respond to traditional treatments. While the evidence is promising, the findings are tempered by limitations, such as heterogeneity among the included studies and an inability to analyze all relevant outcomes due to limited data. Conclusion:: BoTN was significantly correlated with increases in IELT and the SHIM, enhancements in EHS and PSV. These studies report that BoTN has potential as a treatment approach for male sexual dysfunction, and its further application should be investigated.

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Publication Details

Journal
Current Drug Research Reviews
Published
2026-03-27
DOI
https://doi.org/10.2174/0125899775434881260214052930
Primary Topic
Sexual function and dysfunction studies
Type
article
Field-Weighted Citation Impact
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article

Efficacy of Botulinum Toxin Injections for Erectile Dysfunction and Premature Ejaculation: A Meta-Analysis of Randomized Controlled Trials

Badr Saadawi, Saud Nayef Aldanyowi, A. A. A. Alghamdi, Alaa Ismail et al.
Current Drug Research Reviews
Sexual function and dysfunction studies
article

Efficacy of Botulinum Toxin Injections for Erectile Dysfunction and Premature Ejaculation: A Meta-Analysis of Randomized Controlled Trials

Badr Saadawi, Saud Nayef Aldanyowi, A. A. A. Alghamdi, Alaa Ismail, Hasan Ali Abdullah AlAidarous, Abdulsalam Mohammed Aleid, Zinab Awad alatawi
article en

Abstract

Background:: Male sexual dysfunction, with specific reference to erectile malfunction and premature ejaculation, interferes with both physical and social health of individuals. Erectile dysfunction is seen as the inability to obtain a construction that is rigid enough for successful sexual intercourse, while premature ejaculation is defined as the premature discharge that triggers discomfort. Botulinum toxin, a neurotoxin that blocks acetylcholine release, is thought to lower SMH tone and alter neurotransmitter substrates presumed to be involved in these disorders. Here, we present a systematic review and metaanalysis to determine the efficacy of Botulinum toxin injections in the treatment of erectile dysfunction and premature ejaculation. Methods:: A comprehensive literature review was executed across various databases, including PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, and Scopus, to identify relevant randomized controlled trials evaluating the efficacy of botulinum toxin injections for sexual dysfunction disorders. Subsequently, a meticulous extraction of pertinent information was performed, followed by the extraction of outcomes of interest. A meta-analysis was conducted employing a random effects model using RevMan software. Results:: This systematic review and meta-analysis included eight clinical trials (n = 742 patients) evaluating the efficacy of botulinum toxin (BoTN) in sexual dysfunction. For premature ejaculation, BoTN significantly increased intravaginal ejaculatory latency time (IELT) compared to control (MD = 17.63 seconds, 95% CI [6.69, 28.57], p = 0.02). In erectile dysfunction, BoTN demonstrated significant improvements in the Sexual Health Inventory for Men (SHIM) score at both 2 weeks (MD = 3.25 points, 95% CI [1.10, 5.40], p = 0.03) and 3 months (MD = 5.30 points, 95% CI [2.60, 8.00], p = 0.0001). Discussion:: Botulinum toxin (BoTN) demonstrates significant therapeutic potential for treating both premature ejaculation, by effectively increasing ejaculatory latency, and erectile dysfunction, by improving key indicators like erection hardness and penile blood flow. Its novel mechanism, which involves relaxing hypertonic smooth muscle and modulating peripheral neurotransmission, offers a valuable approach for patients who do not respond to traditional treatments. While the evidence is promising, the findings are tempered by limitations, such as heterogeneity among the included studies and an inability to analyze all relevant outcomes due to limited data. Conclusion:: BoTN was significantly correlated with increases in IELT and the SHIM, enhancements in EHS and PSV. These studies report that BoTN has potential as a treatment approach for male sexual dysfunction, and its further application should be investigated.

Current Drug Research ReviewsVol. 18
Taif University (SA), King Abdullah International Medical Research Center (SA), King Abdullah Medical City (SA), King Faisal University (SA), Al Baha University (SA), University of Tabuk (SA)
Openalex Percentile: Top 3%
Sexual function and dysfunction studies
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