Elisa Maseroli1, Irene Scavello1, Giulia Rastrelli1, Erika Limoncin2, Sarah Cipriani1, Giovanni Corona3, Massimiliano Fambrini4, Angela Magini1, Emmanuele A Jannini2, Mario Maggi5, Linda Vignozzi6. 1. Sexual Medicine and Andrology Unit, Department of Experimental, Clinical, and Biomedical Sciences "Mario Serio", University of Florence, Florence, Italy. 2. Endocrinology and Medical Sexology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. 3. Endocrinology Unit, Medical Department, Azienda Usl Bologna Maggiore-Bellaria Hospital, Bologna, Italy. 4. Gynecology and Obstetrics Unit, Department of Experimental, Clinical and Biomedical Sciences "Mario Serio", University of Florence, Florence, Italy. 5. Sexual Medicine and Andrology Unit, Department of Experimental, Clinical, and Biomedical Sciences "Mario Serio", University of Florence, Florence, Italy; Istituto Nazionale Biostrutture e Biosistemi, Rome, Italy. 6. Sexual Medicine and Andrology Unit, Department of Experimental, Clinical, and Biomedical Sciences "Mario Serio", University of Florence, Florence, Italy; Istituto Nazionale Biostrutture e Biosistemi, Rome, Italy. Electronic address: linda.vignozzi@unifi.it.
Abstract
INTRODUCTION: Although vaginismus is a condition with a great impact on psychosexual well-being, the evidence on the efficacy of interventions is lacking. AIM: To review all information on vaginismus treatment, including data from randomized clinical trials (RCTs) and observational studies. METHODS: A systematic search was conducted of MEDLINE, EMBASE, PsycINFO, and ClinicalTrials.gov. 2 Independent meta-analyses of RCTs and observational studies were performed. For RCTs, only those having no treatment as the comparator were considered eligible. MAIN OUTCOME MEASURE: The primary outcome was the success rate (number of successes/total sample) in the completion of sexual intercourse. RESULTS: 43 Observational studies (n = 1,660) and 3 RCTs (n = 264) were included in the final analyses, respectively. In the meta-analysis of RCTs, the use of psychological interventions showed a trend toward a significantly better result vs waiting list control (OR 10.27 [95% CI 0.79-133.5], P = .075). The combination of the results obtained from the observational studies showed that treating vaginismus is associated with the completion of sexual penetrative intercourse in 79% of cases, independently of the therapy used (success rate 0.79 [0.74-0.83]). When only moderate- or strong-quality studies were considered, the success rate was 0.82 (0.73-0.89). As for the different definitions of vaginismus, studies with unconsummated marriage as the inclusion criterion showed the worst success rate (0.68). The origin of vaginismus (primary, secondary, or both), its duration, the mean age of the participants, the involvement of the partner in the intervention, or the geographic setting did not exert a significant effect on the outcome. Studies enrolling women with unconsummated marriage showed a significantly worse success rate. CLINICAL IMPLICATIONS: No approach is superior to the others in allowing the achievement of penetrative intercourse in women with vaginismus. STRENGTH & LIMITATIONS: Only studies specifically enrolling patients with vaginismus were selected, and analyses were performed on an intention-to-treat approach. The main limitations are the small number of trials in the meta-analysis of RCTs and the lack of a comparison group in the meta-analysis of observational studies, which cannot rule out a placebo effect. Due to the limited evidence available, great caution is required in the interpretation of results. Further well-designed trials, with more appropriate outcomes than penetrative sex, are required. CONCLUSION: The meta-analysis of RCTs documented a trend toward higher efficacy of active treatment vs controls, whereas the meta-analysis of observational studies indicated that women with vaginismus benefit from a range of treatments in almost 80% of cases. Maseroli E, Scavello I, Rastrelli G, et al. Outcome of Medical and Psychosexual Interventions for Vaginismus: A Systematic Review and Meta-Analysis. J Sex Med 2018;15:1752-1764.
INTRODUCTION: Although vaginismus is a condition with a great impact on psychosexual well-being, the evidence on the efficacy of interventions is lacking. AIM: To review all information on vaginismus treatment, including data from randomized clinical trials (RCTs) and observational studies. METHODS: A systematic search was conducted of MEDLINE, EMBASE, PsycINFO, and ClinicalTrials.gov. 2 Independent meta-analyses of RCTs and observational studies were performed. For RCTs, only those having no treatment as the comparator were considered eligible. MAIN OUTCOME MEASURE: The primary outcome was the success rate (number of successes/total sample) in the completion of sexual intercourse. RESULTS: 43 Observational studies (n = 1,660) and 3 RCTs (n = 264) were included in the final analyses, respectively. In the meta-analysis of RCTs, the use of psychological interventions showed a trend toward a significantly better result vs waiting list control (OR 10.27 [95% CI 0.79-133.5], P = .075). The combination of the results obtained from the observational studies showed that treating vaginismus is associated with the completion of sexual penetrative intercourse in 79% of cases, independently of the therapy used (success rate 0.79 [0.74-0.83]). When only moderate- or strong-quality studies were considered, the success rate was 0.82 (0.73-0.89). As for the different definitions of vaginismus, studies with unconsummated marriage as the inclusion criterion showed the worst success rate (0.68). The origin of vaginismus (primary, secondary, or both), its duration, the mean age of the participants, the involvement of the partner in the intervention, or the geographic setting did not exert a significant effect on the outcome. Studies enrolling women with unconsummated marriage showed a significantly worse success rate. CLINICAL IMPLICATIONS: No approach is superior to the others in allowing the achievement of penetrative intercourse in women with vaginismus. STRENGTH & LIMITATIONS: Only studies specifically enrolling patients with vaginismus were selected, and analyses were performed on an intention-to-treat approach. The main limitations are the small number of trials in the meta-analysis of RCTs and the lack of a comparison group in the meta-analysis of observational studies, which cannot rule out a placebo effect. Due to the limited evidence available, great caution is required in the interpretation of results. Further well-designed trials, with more appropriate outcomes than penetrative sex, are required. CONCLUSION: The meta-analysis of RCTs documented a trend toward higher efficacy of active treatment vs controls, whereas the meta-analysis of observational studies indicated that women with vaginismus benefit from a range of treatments in almost 80% of cases. Maseroli E, Scavello I, Rastrelli G, et al. Outcome of Medical and Psychosexual Interventions for Vaginismus: A Systematic Review and Meta-Analysis. J Sex Med 2018;15:1752-1764.
Authors: Barbara Wagner; Margarete Steiner; Dominikus Franz Xaver Huber; Richard Crevenna Journal: Wien Klin Wochenschr Date: 2021-03-22 Impact factor: 1.704