Archivio Italiano di Urologia e Andrologia 2017; 89, 2148 SHORT COMMUNICATIONS Pharmacological/dynamic rehabilitative behavioural therapy for premature ejaculation: Results of a pilot study Franco Mantovani Clinica San Giovanni, Milan, Italy. Objectives: Premature ejaculation (PE) is a sexual disorder characterised by excessive rapidity of orgasm. It is defined as either primary (60%), present since the onset of sexual activity, or secondary (40%), manifesting later in life. To date, dapoxetine is the only prepa- ration approved for the on-demand treatment of PE. However, side effects, costs associated with the treatment of chronic PE, drug dependence and its variable effectiveness leads to a not insignificant drop-out rate. Dynamic rehabilitative/behavioural therapy may be a viable therapeutic option, working alongside pharmacological treatment, as long as the participation and involvement of both the individual and the couple is optimal. Materials and methods: 18 patients were enrolled, aged between 25 and 55 (mean: 40), all with primary PE, free of comorbidities and with their partners involved. Six patients were prescribed 30 mg dapoxetine two hours before sexual relations for 3 months (group A); 6 patients began the dynamic rehabilitative treatment (group B); 6 other couples were assigned to pharma- cological treatment in association with dynamic rehabilitative behavioural treatment for 3 months (group C). Division of subjects was carried out by simple randomisation, excluding patients with a short frenulum, phimosis, ED, chronic prostatitis or experiencing results from previous treatment. Results: Outcomes of treatment were evaluated at the end of the 3 months of treatment and 3 months after discontinuing treat- ment. In Group A 75% of patients were cured at 3 months and 25% at 6 months. In Group B 25% patients were cured at 3 months and 25% at 6 months. In Group C 75% of patients were cured 3 months and 50% at 6 months. "Cured" means a Premature Ejaculation Diagnostic Tool (PEDT) score reduced from an average of 12 to an average of 6 and Intravaginal Ejaculation Latency Time (IELT) values from < 1 to > 6 minutes. Conclusions: the integration of pharmacological treatment with dynamic behavioural rehabilitation has the specific aim of optimising and stabilising the results, supporting a more effi- cient recovery of ejaculatory control. The close involvement of the partner is extremely useful for all results. KEY WORDS: Premature ejaculation; Dapoxetine; Perineal rehabilitation; Vacuum device; Sex-therapy. Submitted 14 April 2017; Accepted 23 April 2017 Summary No conflict of interest declared. ondary (30%), manifesting later in life. They share the symptoms of reduced ejaculation latency times, a lack of control and/or subjective perception of the time of ejac- ulation. The etiopathogenesis may be somatic and/or neurobiological, which is often is associated with a sig- nificant psychosexual component and intimate discom- fort. Our diagnosis was based mainly on anamnestic- clinical and laboratory data (hormones, Meares-Stamey tests, semen cultures). PEDT questionnaires (Premature Ejaculation Diagnostic Tool) and IELT tests (Intravaginal Ejaculation Latency Time) were very useful during the research, while electrophysiological tests presented more difficulties in terms of execution and interpretation (1, 2). Assuming that the treatment of choice should be causative, the vast majority of patients will be excluded from treatment, because a precise identification of the causes is lacking in most of the patients that often are not able to completely resolve the disease (3). In the phar- macological field Dapoxetina is, to date, the only prepa- ration approved for the on-demand treatment of PE. Unlike conventional selective serotonin reuptake inhibitors (SSRI), it allows for use on an as-needed basis (not requiring a window to take effect), has a good safe- ty profile, and does not present the risk of developing a withdrawal syndrome after discontinuation (4). However, the side effects (nausea, headaches, dizziness, diarrhoea), the costs associated with the treatment of chronic PE, drug dependence and its variable effective- ness leads to a not insignificant drop-out rate. Although there are no clinical studies of sufficient quality to gener- ate high levels of scientific evidence, dynamic rehabilita- tive/behavioural therapy may be a viable therapeutic option, working alongside pharmacological treatment, as long as the participation and involvement of both the individual and the couple is optimal following simple, precise and controlled explanations, examples and train- ing (5). MATERIALS AND METHODS Eighteen patients were enrolled, aged between 25 and 55 (mean: 40), all with primary PE, free of comorbidities and with their partners involved. Six patients were prescribed 30 mg dapoxetine two hours before sexual relations for 3 months, six patients began dynamic rehabilitative treat- ment consisting of toning the pubococcygeus (the funda- DOI: 10.4081/aiua.2017.2.148 INTRODUCTION Premature ejaculation (PE) is a sexual disorder charac- terised by excessive rapidity of orgasm. On average, from international case studies, it affects 25% of the male pop- ulation aged 25 to 55. It is defined as either primary (70%), present since the onset of sexual activity, or sec- Mantovani2_Stesura Seveso 21/06/17 10:04 Pagina 148 149Archivio Italiano di Urologia e Andrologia 2017; 89, 2 Rehabilitation for premature ejaculation mental perineal muscle for ejaculation control) by means of daily home physiotherapy following outpatient demon- stration and by weekly application (for 3 months) in an outpatient clinic of extracorporeal magnetic innervation (ExMI-Neocontrol) followed by functional electrical stimu- lation (FES) and biofeedback (BFB) with rectal probe (MyoPlus 40Hz) in a dynamic setup with erection induced and maintained using a Vacuum device (Rapport-Medis) (Figure 1). Over the 3 month period the couple was also trained in home behavioural therapy (Sensate - Squeeze - Stop and Start). Six other couples were assigned to phar- macological treatment associated with dynamic rehabilita- tive behavioural treatment for 3 months. Assignment of subjects to treatment was carried out by simple randomi- sation, after excluding patients with a short frenulum, phi- mosis, erectile dysfunction, chronic prostatitis or experi- encing results from previous treatment. The muscle rehabilitation procedure is largely adapted from the established procedure for urinary incontinence, but it is carried out during a vacuum-induced erection for identification with the condition of the penis when ejaculatory control is required. The behavioural therapy, through various dedicated exercises, is targeted at the acquisition of greater control over levels of arousal and ejaculation times, rebuilding their self-esteem, which translates into greater confidence during sexual inter- course, thereby reducing anxiety, causing increased ejac- ulation latency times and offering the possibility of greater ease of penetration. RESULTS PEDT questionnaires were filled and IELT values were evaluated by interviews with the couples at the end of the 3 months of treatment and 3 months after the dis- continuation of treatment; fortunately no subjects dropped out or failed to follow-up. In Group A (pharmacological treatment) 75% of patients were cured at 3 months and 25% at 6 months. In Group B (dynamic rehabilitative behavioural therapy) 25% of patients were cured at 3 months and 25% at 6 months. In Group C (pharmacological associated with dynamic rehabilitative behavioural therapy) 75% of patients were cured at 3 months and 50% at 6 months. Positive results were considered a reduction in the PEDT score from an average of 12 to an average of 6 (Figure 2) or an increase of IELT from < 1 to > 6 minutes on aver- age (Figure 3). From the baseline to the evaluation at 3 and 6 months, all groups presented a significant (P < 0.0001) increase in IELT values and a reduction in PEDT score. The difference between group A and group C is particularly significant. In group A (dapoxetine alone) the increase in IELT (in seconds) was significantly lower (84.8-170.9-120.7) compared to group C (complete integrated treatment) (86.2-370.7-232.5) and similarly the decrease in the reduction in PEDT scores was lower in group A than in group C (18.16-9.88-14.68) vs (19.56-5.92-8.96). Figure 1. Dynamic electro-stimulation (FES) associated with use of Vacuum device. Figure 2. Changes in PEDT score. Figure 3. Changes in IELT values. Group A Group B Group C Group A Group B Group C Baseline 3 months 6 months Baseline 3 months 6 months PE DT s co re IE LT v al ue in m in ut es Mantovani2_Stesura Seveso 21/06/17 10:04 Pagina 149 Archivio Italiano di Urologia e Andrologia 2017; 89, 2 F. Mantovani 150 DISCUSSION The integration of pharmacological treatment (6) with a dynamic rehabilitative behavioural approach (7) has the specific aim of optimising and stabilising the results, supporting the patient in a more efficient recovery of lasting ejaculatory control (8). To that effect, the involve- ment of the partner in the therapeutic process is extremely useful, as the establishment of greater involve- ment in the sexual relationship provides further stimulus for the patient in the recovery of their self-esteem, virili- ty and sense of adequacy of their sexuality. (9) In addi- tion, the involvement of the couple is extremely useful in mitigating the drop-out rate associated with the pharma- cological treatment and effectively reducing the difficul- ty of keeping the patient committed to the integrated treatment plan. The limits of this study, despite the prospective nature of the study and the use of three treat- ment groups, include the reduced number of patients enrolled in the study and the limited time of the follow- up. Further comparative studies are necessary to assess in more detail the actual significance of the therapeutic approaches to be proposed for PE. In conclusion, these integrated treatments, alternating concentration and relaxation, create an impression of real control in overcoming this issue. Excluding the cases with comorbidities that have to be resolved first, the administration of dapoxetine is beneficial in terms of immediate results. Its use in conjunction with dynamic perineal rehabilitation and behavioural therapy offers significant advantages and a more appreciable stability along time of the results. REFERENCES 1. Althof SE, et al. International Society for Sexual Medicine’s guide- lines for the diagnosi and treatment of premature ejaculation. 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Steggall M, Fowler C, Pryce A. Combination therapy for PE: results of a small-scale study. Sex and Relationship Therapy. 2008; 23:365-76. 9. Perelman M. A new combination treatment for premature ejacu- lation. A sex therapist’s prospective. J Sex Med. 2006; 3:1004-1. Correspondence Franco Mantovani, MD mantovanifranco@yahoo.it Clinica San Giovanni via Civitali 71, Milano, Italy Mantovani2_Stesura Seveso 21/06/17 10:04 Pagina 150