G. Del Popolo

Time/duration effectiveness of sildenafil versus tadalafil in the treatment of erectile dysfunction in male spinal cord-injured patients

Study design: A randomized, blinded, crossover clinical trial comparing sildenafil versus tadalafil for erectile dysfunction (ED) in male spinal cord-injured (SCI) patients.Objectives: To compare the safety, time/duration effectiveness, and the impact on the quality of life (QoL) of tadalafil 10 mg versus sildenafil 50 mg.Setting: Neurourology Section, Careggi Hospital, Florence, Italy.Methods: During a screening (visit 1), a diary card was distributed, in which the subjects assessed, after each attempt at intercourse the quality of their erection, responding (Yes/No) to both Sexual Encounter Profile Questions 2 (SEP2) and 3 (SEP3). The subjects made at least four attempts at intercourse. At visit 2, 15 patients (group 1) were assigned sildenafil and 15 (group 2) started with tadalafil. Responses to baseline International Index of Erectile Function 5 items (IIEF-5), Questions 13–14 (IIEF 15 items) and SEP diary were recorded. Patients attempted intercourse on four separate occasions: within 4 h of taking the first tablet, within 12 h for the second tablet, 24 h for the third, and the fourth from 24 to 36 h. At visit 3, the investigators evaluated the effectiveness with the same measures used at baseline. After a wash-out period, at visit 4, Group 1 was given tadalafil, and Group 2 was given sildenafil. Patients were required to observe the same criteria in taking the four tablets as in visit 2. After 4 weeks (visit 5), we evaluated the patients as we did in visit 3.Results: Overall, 28 patients completed the study. No subjects discontinued the drugs due to drawbacks.Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 h postdosing compared to sildenafil (P<0.01) and improved overall sex life satisfaction as well as sexual relations with partner.Conclusion: Based on these data, tadalafil may have the potential to become an important treatment option for ED in SCI patients.Sponsorship: This study was not sponsored.

Clinical outcome of sacral neuromodulation in incomplete spinal cord injured patients suffering from neurogenic lower urinary tract symptoms

Objective:To determine the efficacy and safety of sacral neuromodulation (SNM) in incomplete spinal cord injured (SCI) subjects affected by neurogenic lower urinary tract symptoms (NLUTS).Methods:Twenty-four SCI patients were enrolled. The individuals were divided into two groups: 13 individuals in the urinary retention category and 11 suffering from overactive bladder syndrome. All subjects underwent definitive SNM implantation (Medtronic, Inc.). Voiding symptoms were assessed using patient bladder diaries, which recorded both pre-SNM and before each follow-up (1, 3 and 6 months, and then every 6 months). Outcome measures were per 24 h: number of voids and voided volume per void for both groups; number of urinary leakages, pad use and nocturia for patients with overactive bladder syndrome; and volume per catheterization and number of catheterizations for urinary retention subjects only. Final checkups were completed by June 2008.Results:Median follow-up was 61 months. Up to the final visit, all subjects maintained a clinical improvement of more than 50% compared with baseline. Twenty-two side effects were recorded. Four subjects with urinary retention needed a new implant in the controlateral S3 sacral root because of loss of efficacy. One patient with urinary retention developed a wound infection at the implanted pulse generator site.Conclusions:Our study contains the largest series of implanted SCI patients ever published. SNM is a therapy to consider in the treatment of NLUTS for partial SCI patients, even if the loss of clinical benefits for patients with retentive NLUTS must be taken into account. All adverse events were treated effectively.

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.

Clinical concomitant benefits on pelvic floor dysfunctions after sacral neuromodulation in patients with incomplete spinal cord injury

Objectives:To assess the concomitant clinical improvement in incomplete spinal cord injury patients (SCIPs) suffering from neurogenic bowel symptoms (NBSs), neurogenic lower urinary tract symptoms (NLUTSs) and neurogenic erectile dysfunction (NED) using sacral neuromodulation (SNM) for NBSs and NLUTSs.Methods:Seventy-five SCIPs were selected. Before and during the follow-ups post-SNM, NLUTSs and NBSs were detected mainly through specific diaries. Erectile function was assessed using the International Index of Erectile Function composed of 5 questions (IIEF5). Quality of life (QoL) was measured with the Short Form 36 Health Survey questionnaire (SF-36). During the first stage, in which a permanent electrode was inserted percutaneously into the third sacral foramina and stimulated using an external generator, patients with NBSs or NLUTSs were required to improve their symptoms by at least 50% compared with baseline before proceeding to the second stage in which the generator was placed in the patients buttock. NED patients needed to increase their IIEF5 score by at least 25% compared with baseline (evaluated initially 3 months after the second stage) in order to continue follow-up.Results:Fourteen out of 37 subjects who manifested two functional pelvic dysfunctions at baseline maintained notable clinical improvement in two pelvic functions (median follow-up >3 years). Six had non-obstructive retention (NOR) and NED, six double incontinence, and two constipation with NOR. In the general and mental health domains of the SF-36, all patients improved their scores by at least 20% compared with baseline.Conclusions:SNM may be beneficial to selected incomplete SCIP with concomitant pelvic functional disturbances.

Sacral neuromodulation for neurogenic non-obstructive urinary retention in incomplete spinal cord patients: a ten-year follow-up single-centre experience

Objective:To determine the success rate of percutaneous first stage of sacral neuromodulation (SNM) and the efficacy and safety of permanent SNM for incomplete spinal cord lesion (SCL) patients suffering from chronic neurogenic non-obstructive urinary retention (N-NOR).Method:From January 2003 to December 2012, 85 individuals underwent the percutaneous first stage of SNM. Subsequently, only responders who reached a concomitant reduction by at least 50% of volume per catheterization and in the number of catheterizations per day comparing their 7-day voiding diaries at baseline underwent permanent SNM. Final follow-up was conducted by April 2013.Results:Thirty-six individuals responded to percutaneous first stage of SNM. Post-surgery urodynamics documented all patients experiencing first sensation of bladder filling. A statistically significant increase in Qmax ml per sec and decrease in post-voiding residual urine per ml were documented. (P<0.01). First sensation of bladder filling at baseline represented a statistically significant parameter for the success of the first stage SNM (P<0.05). Eleven out of 34 patients at follow-ups were ‘inconstant responders’ because they returned to similar baseline voiding symptoms, but responded again with an implant on the controlateral S3 sacral root. Two failed twice and responded once again after an S4 sacral root implant. All but one failure occurred more than 3 years after the previous implant. Other drawbacks were resolved telemetrically.Conclusions:Research is needed to increase the success rate of the first stage SNM on incomplete SCL patients with N-NOR. Permanent SNM is highly efficacious in the medium follow-up.

Heavy smoking is an important risk factor for erectile dysfunction in young men

Clinical and basic science studies provide strong indirect evidence that smoking may affect penile erection. The objective of this retrospective research was to investigate the role of smoking for erectile dysfunction (ED) in order to obtain some insight into the prevention of ED. We reviewed the data from 860 male patients aged between 18 and 44 visited during the period January 1999 to December 2002. The patients were divided into three groups: smokers, never smokers and former smokers. All patients were submitted of medical history, such as, IIEF 5 Questionnaire, physical examination, serum levels of glucose, cholesterol, prolactin and free testosterone. Our data were compared with ISTAT (Italian Institute of Statistics) and data on the Italian population of smokers. We have stratified the data by age and area of residence. The 860 patients, mean age 32.4 y old (range 18–44), are distributed into three groups: smokers 460 (53.5%), never smokers 320 (37.2%) and former smokers 80 (9.3%). Current smokers in our series are 460 (53.5%) in comparison to 34.7% of male current smokers in Italy, in the same range (18–44). Out of 860, 337 are patients who smoked more than 20 cigarettes per/day (39.2%) and these data are extremely interesting; while comparing the same aged men through ISTAT, it is found that only 4% are heavy smokers. On analysing the incidence of heavy smoking in middle-aged patients affected by ED with the whole Italian population by means of ISTAT, taking into account males with the same age range and area of residence, it was shown that the data of our population (sample) compared all Italian middle-aged patients are 39.2 vs 4%; this explains the need for education within a comprehensive smoking cessation programme, and should be reserved especially for young smokers, in order to be aware and informed of the effect of tobacco on erectile function.

Controversy over the pharmacological treatments of storage symptoms in spinal cord injury patients: a literature overview

Study design:Our aim was to locate research and communicate the evidence found from scientific studies pertaining to the treatment of neurogenic detrusor overactivity (NDO) in the chronic stage of spinal cord injury (SCI).Objective:To address the controversy over the traditional (antimuscarinics) and the ‘new’ treatments for NDO and try to offer an insight on the rationale underlying the development of new drugs such as botulinum toxin (BTX), vanilloids, nociceptin/orphanin FQ. As a final point, to provide information on a new class of cation channels, the Degenerin/Epithelial Na+Channel (Deg/ENaC) Family that could be future targets for the management of NDO.Setting:International.Methods:Overview of English literature on drug management of NDO.Results:Agents that block the ‘efferent’ function of micturition reflex, such as antimuscarinics, are currently first-line therapy for NDO. They reach the highest level of evidence (1a) and grade of recommendation (A). However, many patients and physicians believe that the ‘efferent’ pharmacological management of NDO is not completely satisfactory. Consequently, research is trying to address issues of efficacy, tolerability and convenience of new therapeutic strategies targeting the ‘afferent’ function.Conclusion:Antimuscarinic therapy increases the bladder capacity and delays the initial urge to void. However, in some patients they fail to achieve the patients therapeutic goals. New interesting approaches have been investigated in the last few years. BTX seems to be very promising in treating neurogenic overactive bladder (OAB), but other compounds are now on the horizon.

Recommendations for the management of urinary disorders in multiple sclerosis: a consensus of the Italian Multiple Sclerosis Study Group.

Urinary disorders are uncommon in the initial phases of multiple sclerosis, but increase in frequency as the disease progresses, with a negative impact on quality of life. The goal of this study was to propose a protocol for the diagnosis and treatment of urinary disorders in multiple sclerosis, based on data from the scientific literature and the experience of Italian clinical centres. In particular, the following clinical aspects were considered: what to do with patients with asymptomatic multiple sclerosis; what to do with symptomatic patients; how and when to perform a second-level diagnostic evaluation; and how to treat urinary disorders. A diagnostic–therapeutic algorithm is proposed, that can be applied in Italian clinical centres.

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.