Angelo Macchiarella

Clinical Female Sexual Outcome after Sacral Neuromodulation Implant for Lower Urinary Tract Symptom (LUTS)

INTRODUCTION Over the last few years, sacral neuromodulation (SNM) has become an established treatment option for lower urinary tract symptoms (LUTS). AIM To evaluate if SNM improves sexual function in females treated with SNM for LUTS. MAIN OUTCOME MEASURES Improvement in sexuality by the Female Sexual Function Index (FSFI) and the Female Sexual Distress Score (FSDS). MATERIALS AND METHODS We included 31 women, 17 of whom were neurogenic with permanent SNM. Prior to the neuromodulation screening, we assessed sexual function through blood sexual hormones, the FSFI and the FSDS questionnaires. Significant enhancement in sexuality meant an increase of 60% of the total score or of one FSFI domain, or 50% improvement on the FSDS. Only females who showed significant benefits in the first visit post-permanent SNM repeated the questionnaires in follow-up. All these women had their final visit by July 2007. RESULTS Both questionnaires indicated a clinically significant improvement in sexuality that was maintained up to the final visit for 4 out of 11 neurogenics with sexual dysfunctions: one showed arousal and desire disorders, one showed arousal disorder and lubrication impairment, one showed arousal disorder and pain, and one showed desire and orgasm deficits. Mean duration of sexual improvement was 23 months. Notable clinical improvement in sexuality was observed in two out of eight idiopathics (one suffering from arousal and desire disorders, and one from lubrication impairment) with a median follow-up of 22 months. CONCLUSIONS The positive effects regarding sexuality may be due either to enhancement of LUTS or to the direct stimulation of the sacral roots (S3).

Sexual rehabilitation in women with spinal cord injury: a critical review of the literature

Study design:Review article.Objectives:Critical review of literature on the multiple aspects of sexual rehabilitation in women with spinal cord injury (SCI) from initial recovery to long-term follow-up.Setting:Neuro-urology Department.Methods:Studies on sexuality selected from PubMed from 1993 to 2009.Results:Literature supported by significant statistical analyses reports that females with complete tetraglegia deserved special attention immediately at initial recovery; sexual intercourse is much more difficult for them (as compared with other women with SCI) mainly because of autonomic dysreflexia and urinary incontinence. There are sparse data on predictable factors favoring sexual rehabilitation such as the age SCI was incurred, the importance of ones sexual orientation, and the SCI etiology. Information after initial discharge is based chiefly on questionnaires, which report that as more time passes since the injury, patients attain more sexual satisfaction compared with recently injured women. Studies on neurological changes after SCI, and their effect on sexual response, are supported by a significant statistical analysis, but with few SCI patients. One topic reported the effect of sildenafil on sexuality, without benefit. No paper offers any detailed analysis on the sexual impact of medical and psychological treatments related to SCI. Literature reports that some co-morbidities are more prevalent in women with SCI compared with able-bodied women but data on sexual functioning are missing.Conclusion:To improve sexual rehabilitation services, sexual issues and response require evaluation during periodical check-ups using validated questionnaires administered by a physician ‘guide’ who coordinates professional operators thus providing personalized programmable interventions.

Clinical outcome of sacral neuromodulation in incomplete spinal cord-injured patients suffering from neurogenic bowel dysfunctions

Study design:Retrospective study.Objectives:Efficacy and safety of sacral neuromodulation (SNM) in incomplete spinal cord-injured patients (SCIPs) affected by chronic neurogenic bowel symptoms (NBSs).Setting:Neurourology Department. Primary to tertiary care.Methods:Retrospective non-blinded study without controls. Thirty-nine SCIPs were submitted to temporary stimulation for NBS. Permanent implantation was carried out if both their NBSs improved and the Wexner questionnaire scores were reduced by at least 50% during the first stage compared with that at baseline. Outcome measures included episodes of fecal incontinence and number of evacuations per week, as well as the Wexner score and the Short Form 36 (SF-36) Health Survey questionnaire.Results:Twenty-three SCIPs were submitted to definitive SNM, maintaining their clinical benefits after permanent implantation with a median follow-up of 38 months. The length of time since neurological diagnosis to SNM therapy represents the only factor related to the success of the implantation, P<0.05. In subjects with constipation (12), the median number of evacuations shifted from 1.65 to 4.98 per week, whereas the Wexner score changed from 19.91 to 6.82 in the final checkup with P<0.05. In subjects with fecal incontinence (11), the median number of episodes per week in the final follow-up was 1.32 compared with 4.55 pre-SNM. The general and mental health of both groups was measured with the SF-36 questionnaire and consistently showed statistical improvement (P<0.05).Anorectal manometry showed no important variation compared with baseline. There were no major complications.Conclusions:SNM therapy should be considered for the treatment of NBS for select patients with incomplete spinal cord injury when conservative treatments fail.

Sacral neuromodulation for lower urinary tract dysfunction and impact on erectile function.

INTRODUCTION The first sacral nerve stimulators were for urinary urgency incontinence, urgency-frequency, and nonobstructive urinary retention. Since then, observations have been made for benefits beyond voiding disorders. AIM To evaluate if sacral neuromodulation (SNM) using the InterStim system (Medtronic Inc., Minneapolis, MN, USA) improves erectile function. METHODS From January 1999 to January 2007, 54 males, mean age 42.8, underwent a permanent SNM for lower urinary tract symptoms (LUTS). Pre-SNM only subjects with concomitant erectile impairment according to the five-item version of the International Index of Erectile Function (IIEF-5), with normal blood sexual hormonal status, and responding to an intracavernous injection test 10 microg were enrolled in our study. Three months after permanent implantation, the IIEF-5 was completed again. Those who benefited significantly in erectile function completed the IIEF-5 semiannually. A final checkup was performed in July 2007. MAIN OUTCOME MEASURES A score of IIEF-5 equal to or higher than 25% compared to baseline indicated remarkable clinical enhancement. RESULTS Presurgery, two patients were excluded. Overall, 22 subjects (42.3%) showed erectile impairment (14 were neurogenic). In the first visit post-SNM, five retentionists of neurogenic origin and two with overactive bladder syndrome of idiopathic origin achieved noticeable erectile improvement. Their median IIEF-5 score shifted from 14.6 to 22.2, and 15.5 to 22.5, respectively. During follow-up, two neurogenics lost the benefits concerning voiding and erection and recovered them after a new implant in the contralateral sacral S3 root. In the final visit, the seven responders reached an IIEF-5 score of at least 22. CONCLUSIONS Our study showed a clinically important benefit of sexual function mainly for neurogenic retentionists. Future research should test SNM in a larger sample of subjects, exclusively with sexual dysfunctions, in order to better understand the mechanism of action of SNM on erectile function.

Efficacy and Safety of Tadalafil for Erectile Dysfunction in Patients with Multiple Sclerosis

INTRODUCTION Data are sparse concerning the effects of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction (ED) in subjects with multiple sclerosis (MS). AIM To evaluate the efficacy and safety of tadalafil use in subjects with ED because of MS. METHODS Ninety-six MS patients with ED after a 4-week treatment-free period were given tadalafil 10 mg. All patients were re-evaluated after 4 weeks. Those with a score lower than 26 on the International Index of Erectile Function (IIEF-15) and with less than 75% of total successful sexual attempts assessed by the Sexual Encounter Profile Questions 2 and 3 (SEP2-3) had their dosage of tadalafil increased to 20 mg, whereas responding subjects continued with 10 mg. Subsequently, all patients had a final follow-up visit after 8 weeks. MAIN OUTCOME MEASURES SEP2-3, IIEF-15 questionnaire. The Life Satisfaction Checklist (LSC) questionnaire composed of eight questions was used prior to starting tadalafil and at the end of the 12-week treatment. RESULTS Ninety-two subjects completed the study. Seventy-two responded, 30 of whom used 10 mg. Two subjects discontinued the therapy because of moderate side effects: one suffered from headache and one from tachycardia. Responding patients reached a significant statistical improvement in all follow-ups compared with baseline on the erectile domain and overall sexual satisfaction scores of the IIEF-15 using the Wilcoxon test P < 0.01. Furthermore, they showed statistical improvement through the Wilcoxon test P < 0.01 on the sexual life, family life, and partner relationship questions of the LSC compared with baseline. CONCLUSION Tadalafil is an effective and safe treatment for males with MS suffering from ED. Further studies are needed on MS patients to evaluate the efficacy and safety of long-term use, and to detect predictable parameters for the success of PDE5 inhibitors.

Ten Years of Phosphodiesterase Type 5 Inhibitors in Spinal Cord Injured Patients

INTRODUCTION The majority of men with spinal cord injury (SCI) require chronic treatment for erectile dysfunction (ED), but most of them, prior to taking phosphodiesterase type 5 (PDE5) inhibitors, stopped therapy due to side-effects or low compliance rate. AIM Analysis of literature on oral PDE5 inhibitors in individuals with SCI and ED in order to evaluate how much their release changed the management of ED in SCI subjects and what remains to be seen of their potential or limits. MAIN OUTCOME MEASURES Questionnaires on sexual function. METHODS 18 internationally published clinical studies that enrolled SCI males treated with at least one of the PDE5 inhibitors were analyzed. RESULTS The small numbers of papers with large and diverse outcome measures did not consent a meta-analysis of treatment results. 705 used sildenafil, 305 vardenafil and 224 tadalafil. Median age was less than 40 years. Only 1 study excluded tetraplegic individuals. For measures of ED evaluated, 11 out of 13 studies reported a significant statistical improvement with PDE5 inhibitors versus placebo or erectile baseline (P < 0.01, or p < 0.005). The most frequent predicable factor for the therapeutic success of PDE5 inhibitors was upper motoneuron lesion. Statistical impact on ejaculation success rates was shown in at least one paper for all PDE5 inhibitors (p < 0.05). Overall, 15 patients, (7 using sildenafil), discontinued the therapies due to drawbacks. Only 1 sildenafil study reported a follow-up maximum of 24 months. CONCLUSIONS Literature suggests that all oral PDE5 inhibitors represent a safe and effective treatment option for ED caused by SCI. Further research is needed on head-to-head comparative trials and SCI patient preference for these drugs; their impact on ejaculation and orgasm function, their early use after SCI for increasing the recovery rate of a spontaneous erection, and their effectiveness and tolerability in the long-term are still to be investigated.

Ten-Year Follow-Up of Sildenafil Use in Spinal Cord-Injured Patients with Erectile Dysfunction

INTRODUCTION Data are sparse concerning the long-term effects of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction (ED). AIM To evaluate the efficacy and safety of long-term sildenafil use in subjects with ED caused by spinal cord injury (SCI). METHODS Phase 1: From October 1998 to January 1999, 113 SCI patients with ED were given 50 mg of sildenafil after a 4-week treatment-free period. Those with a score lower than 26 on the International Index of Erectile Function (IIEF-15) and with less than 75% total successful sexual attempts the dosage of sildenafil was increased to 100 mg. Attempts were evaluated using the Sexual Encounter Profile Questions 2 and 3 (SEP2 and 3) regarding respectively the capacity to penetrate their partner and to maintain the erection after penetration. Phase 2: Only responding patients entered phase 2 where they were evaluated every 6 months. The final visit was concluded by January 2009. MAIN OUTCOME MEASURES Follow-up using the IIEF-15 questionnaire every 6 months. RESULTS Seventy-five patients entered Phase 2. Thirty-eight patients were excluded, 35 of them because they did not respond to the drug. Lesions higher than T12, an incompleteness of lesions, and higher residual erection were significant predictable factors for the success of the therapy (P < 0.05). Phase 2: the most frequent reason (68.3%) for discontinuing treatment was the desire to try a new oral therapy especially for patients using 100 mg. Thirty-four individuals continued treatment, 28 of whom took 50 mg. CONCLUSION Sildenafil represents an effective and safe long-term option for SCI subjects with ED. Further investigation of long-term use of oral PDE5 inhibitors in SCI patients is needed for evaluating both factors that are determinant in the choice of a starter treatment and in detecting elements that influence the switching from initial treatment.

Sexual life of males over 50 years of age with spinal-cord lesions of at least 20 years.

Background:To assess over the past year the sexuality of male patients with spinal-cord injury (SCI) over 50 years of age with spinal lesions of at least 20 years.Methods:Subjects were stratified in two groups: 44 individuals under 60 years and 55 individuals over 60 years. A detailed sexual anamnesis was taken for all, and the SF-36 Health Survey questionnaire was completed, with questions 13 and 14 concerning overall sexual life answered through the International Index of Erectile Function.Results:The younger group reached a median score of +50 for each domain of the SF-36; however, the differences between the two groups are not statistically relevant. The physical domain of the SF-36 showed a median score of 43.2 for the younger versus 41.1 for the older, whereas the mental domain showed 44.8 and 43.1, respectively. In the first group, 29/44 (65.9) individuals claimed erectile dysfunction versus 43/55 (78.1%) in the second, whereas 34/44 (77.2%) of the first group reported having sexual intercourse versus 13/55 (23.6%) with P<0.01 (χ2 test). In the 2nd, 29/55 (52.7%) individuals reported physical intimacy without sexual intercourse. For each group, the overall sexual satisfaction is statistically correlated to the duration of the relationship (linear progression test P<0.05).Conclusions:Median quality of life was high. Sexual intercourse is fundamental only for males of the first group. Most aging couples presented a different way of thinking about sex without the need for intercourse. Physicians should acquire knowledge about sexuality and aging in SCI patients.Sponsorship:This study was not sponsored.

ORIGINAL RESEARCHSacral Neuromodulation for Lower Urinary Tract Dysfunction and Impact on Erectile Function

INTRODUCTION The first sacral nerve stimulators were for urinary urgency incontinence, urgency-frequency, and nonobstructive urinary retention. Since then, observations have been made for benefits beyond voiding disorders. AIM To evaluate if sacral neuromodulation (SNM) using the InterStim system (Medtronic Inc., Minneapolis, MN, USA) improves erectile function. METHODS From January 1999 to January 2007, 54 males, mean age 42.8, underwent a permanent SNM for lower urinary tract symptoms (LUTS). Pre-SNM only subjects with concomitant erectile impairment according to the five-item version of the International Index of Erectile Function (IIEF-5), with normal blood sexual hormonal status, and responding to an intracavernous injection test 10 microg were enrolled in our study. Three months after permanent implantation, the IIEF-5 was completed again. Those who benefited significantly in erectile function completed the IIEF-5 semiannually. A final checkup was performed in July 2007. MAIN OUTCOME MEASURES A score of IIEF-5 equal to or higher than 25% compared to baseline indicated remarkable clinical enhancement. RESULTS Presurgery, two patients were excluded. Overall, 22 subjects (42.3%) showed erectile impairment (14 were neurogenic). In the first visit post-SNM, five retentionists of neurogenic origin and two with overactive bladder syndrome of idiopathic origin achieved noticeable erectile improvement. Their median IIEF-5 score shifted from 14.6 to 22.2, and 15.5 to 22.5, respectively. During follow-up, two neurogenics lost the benefits concerning voiding and erection and recovered them after a new implant in the contralateral sacral S3 root. In the final visit, the seven responders reached an IIEF-5 score of at least 22. CONCLUSIONS Our study showed a clinically important benefit of sexual function mainly for neurogenic retentionists. Future research should test SNM in a larger sample of subjects, exclusively with sexual dysfunctions, in order to better understand the mechanism of action of SNM on erectile function.