Predicting participation in and successful outcome of a penile rehabilitation programme using a phosphodiesterase type 5 inhibitor with a vacuum erection device after radical prostatectomy.

UNLABELLED: Study Type--Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? The role of the vacuum erection device (VED) has increased with its use in combined therapy with a phosphodiesterase type 5 inhibitor (PDE5i) for penile rehabilitation after radical prostatectomy (RP) and radiotherapy. The advantages of the VED are non-invasive, cost-effective, and a possibility of preventing shrinkage of penis length. Albeit current widespread use of penile rehabilitation programmes for post-RP erectile dysfunction, independent predictors for the rehabilitation participants, as well as for its treatment success have not been fully investigated. In the present study, we have added several new predictors for rehabilitation participation, e.g. African-Americans and higher preoperative sexual function. Conversely, higher preoperative PSA concentrations and the presence of positive surgical margins were predictors for avoidance of rehabilitation. Notably, there was a primary surgeon difference, which had a trend for predicting outcome of the rehabilitation among the participants, implying their surgical technique and follow-up might influence success of the rehabilitation. OBJECTIVES: • To investigate baseline demographic and clinicopathological characteristics of men who participate in our penile rehabilitation programme after radical prostatectomy (RP). • To determine predictors for participation in rehabilitation, as well as successful rehabilitation outcome using multivariable logistic regression analyses. PATIENTS AND METHODS: • We analysed data on 2345 consecutive patients who underwent RP between 2001 and 2009 in our institution. • The decision to participate in penile rehabilitation using phosphodiesterase type 5 inhibitor (PDE5i) with a vacuum erection device (VED) was based on the patient's choice after post-RP discussions. • Rehabilitation success was defined using the following criteria: (i) patients who continued the penile rehabilitation programme and did not switch treatment from PDE5i to other erectile aids, (ii) success was noted in men who had an Expanded Prostate Cancer Index Composite (EPIC) sexual function (SF) score of >75% of the patient's baseline EPIC score, and (iii) patients who answered that they achieved adequate erections with a PDE5i. • Logistic regression analysis was used to identify factors associated with treatment participation and its success. RESULTS: • Of 676 patients, 354 (53.2%) men participated in a penile rehabilitation programme. Among 329 rehabilitation participants with available data, 96 (29.2%) had treatment success. • In multivariable regression analysis, African-Americans (odds ratio [OR] 3.47, P < 0.001), and higher preoperative SF (OR 1.02, P < 0.001) were associated with participation in rehabilitation. • Higher preoperative PSA concentration (OR 0.50, P = 0.004) and presence of positive surgical margins (OR 0.68, P = 0.042) were found to be independent predictors for non-participation in the rehabilitation. • For rehabilitation outcomes, being older at surgery (OR 0.93, P = 0.001) and adjuvant therapy (OR 0.34, P = 0.047) had a negative association with successful outcome. • There was a trend in the relationship between primary surgeon and rehabilitation success (OR 1.05, P = 0.053) CONCLUSIONS: • Those patients who have risk factors, e.g. adverse prostate cancer features, need to be carefully counselled and encouraged to participate in the penile rehabilitation programme. • Clinicians could lead patients toward successful outcomes if appropriate surgical techniques and rehabilitation are provided.

[Sexual dysfunction and its consequences in patients with cardiovascular diseases]. / Sexuelle Funktionsstörungen bei Herzkranken und die Folgen.

PURPOSE: Due to the high prevalence of sexual disorders in men and women with cardiovascular disease, the associations between sexual dysfunction, depression, anxiety, quality of life and partnership were investigated. Studies examining impairments to certain aspects of psychological health and interpersonal life in cardiac patients are still lacking. The SPARK (Sexuality of Patients in Rehabilitation of Cardiovascular Diseases) investigation is the first study which explores these relevant associations in German rehabilitation patients. METHODS: Five rehabilitation centers for cardiovascular diseases took part in our cross-sectional study. Associations between sexual dysfunction and depression, anxiety, quality of life and partnership were tested using z-tests (resulting parameter prevalence rate ratio, PRR) and via multiple binary logistic regressions controlling for age and severity of cardiovascular disease as possible confounders (resulting parameter odds ratio, OR). RESULTS: Sexual function could be assessed in 261 men and 75 women (sexual activity during the previous month; for detailed flow chart see Fig. 1). In total, 43.1% of female patients reported a sexual dysfunction, while 20.2% of male patients stated to have at least moderate erectile dysfunction (ED). The proportion of self-assessed sexual problems is shown in Fig. 2. Women with a sexual dysfunction were impaired to a significantly higher extent compared to women without sexual dysfunction with regard to their quality of partnership (PRR 13.0; p=0.019; OR 25.42, confidence interval, CI, 2.5-254.9), anxiety (PRR 3.2; p=0.053; OR 4.43, CI 1.2-16.4) and psychological quality of life (PRR 2.4; p=0.115; OR 6.08, CI 1.6-22.9). Men with ED reported significantly stronger depression (PRR 3.6; p=0.003; OR 3.63, CI 1.5-8.8) and anxiety (PRR 2.4; p=0.008; OR 2.88, CI 1.4-5.9) compared to men without ED. For detailed information see Tables 1 and 2. CONCLUSION: Due to the high proportion of men and women with cardiovascular disease reporting sexual disorders, depression and anxiety, screening for these disorders should be an integral part of comprehensive rehabilitation programs. In particular, the diagnosis and treatment of psychiatric comorbidity seem to be necessary from a tertiary preventive perspective.

Physical activity and PDE5 inhibitors in the treatment of erectile dysfunction: results of a randomized controlled study.

INTRODUCTION: Physical activity (PhA) has proven to be a protective factor for normal erectile function in numerous epidemiological studies. AIM: The aim of this study was to establish if PhA could have a therapeutic role in the treatment of erectile dysfunction (ED). METHODS: This was a randomized, open-label study. A total of 60 patients complaining of ED were studied. Patients were assessed at baseline and after 3 months of study treatment. At baseline, patients were randomized to receive phosphodiesterase type 5 inhibitor (PDE5i) alone (group A) or PDE5i plus regular (≥3 hours/week), aerobic, non-agonistic PhA (group B). MAIN OUTCOME MEASURES: All subjects completed the International Index of Erectile Function (IIEF-15) questionnaire and performed total testosterone (TT). RESULTS: Mean PhA was 3.4 hours/week in group B vs. 0.43 in group A; mean energy expenditure in group B was 1,868 kcal/ week or 22.8 metabolic equivalent (MET)/week. IIEF restoration of ED occurred in 77.8% (intervention group) vs. 39.3% (control) (P < 0.004). The IIEF-15 score resulted in statistical improvement in intervention group in all the domains but one (orgasm): erectile function 24.7 vs. 26.8 (P = 0.003); confidence (Q15) 3.53 vs. 4.07 (P = 0.006); sexual desire 6.46 vs. 7.18 (P = 0.028); intercourse satisfaction 9.85 vs. 11.25 (P = 0.001); total satisfaction 7.17 vs. 8.07 (P = 0.009); total score 56.2 vs. 61.07 (P = 0.007). TT was statistically similar in the two groups; separate analysis in each group showed statistical increase in group B 4.24 vs. 4.55 (P = 0.012). At multivariate logistic regression analysis, PhA was the only independent variable for normal erection (P = 0.010) (95% confidence interval [CI] 0.036-0.643), higher sexual satisfaction (P = 0.022) (95% CI 0.084-0.821) and normal total IIEF-15 score (P = 0.023) (95% CI 0.85-0.837). CONCLUSION: In this randomized controlled pilot study, PDE5i plus PhA was more effective than PDE5i alone in the treatment of ED.

Effect of sexual function on health-related quality of life mediated by depressive symptoms in cardiac rehabilitation. findings of the SPARK project in 493 patients.

INTRODUCTION: Empirical evidence suggests associations between cardiovascular diseases, sexual functioning, depressive symptoms, and quality of life. However, to date, the interrelation of these constructs has not been examined simultaneously in a structural analysis. AIM: To estimate the prevalence of sexual disorders and depressive symptoms and to examine the association between sexual disorders, depressive symptoms, and quality of life in patients in the rehabilitation of cardiovascular disorders. AIM: A postal survey in five German inpatient rehabilitation centers for cardiovascular diseases was conducted. Prevalence of sexual disorders and depressive symptoms were assessed using psychometrically sound instruments. To analyze complex associations, structural equation modeling was used. MAIN OUTCOME MEASURES: For epidemiological questions, proportions with 95% confidence intervals were calculated. The strength of association in structural equation models was expressed as a standardized regression coefficient. RESULTS: Data from 493 patients were analyzed (response rate 22.7%). At least moderate erectile dysfunction proved to be present in 20.3% of men. The prevalence of female sexual dysfunction lay at 43.1%. At least moderate depressive symptoms were present in 14.4% of men and 16.5% of women. A considerable association between sexual functioning and quality of life was found in both sexes, which was largely mediated by depressive symptoms. Major drawbacks of the study are imprecision of the estimates due to limited sample size and questionable generalizability of the findings due to possible self-selection bias. CONCLUSIONS: Considering the high prevalence of depressive symptoms and their role as a mediating factor between sexual functioning and quality of life, it is recommended to routinely screen for depression in men and women with cardiac disease.

Penile rehabilitation following radical prostatectomy: predicting success.

INTRODUCTION: It has been suggested that the institution of a pharmacologically based penile rehabilitation program in the early stages after radical prostatectomy (RP) may benefit some patients. AIM: This analysis was conducted to define if predictors of successful outcome with pharmacological penile rehabilitation following RP could be identified. METHODS: Retrospective statistical analysis was performed on a large database of patients who had participated in a post-RP rehabilitation program. Inclusion criteria included: presence of functional erections permitting sexual intercourse pre-RP and commencement of rehabilitation within 12 months of RP. Patients were instructed to obtain a penetration-rigidity erection on at least three occasions per week and to continue this regimen until at least 18 months after RP using either sildenafil or intracavernosal injection therapy (if oral therapy failed). MAIN OUTCOME MEASURE: International Index of Erectile Function (IIEF) and visual analog scale erectile rigidity assessment. Stepwise logistic regression analysis was used to generate predictors of erectile function (EF) outcomes with penile rehabilitation. RESULTS: Ninety-two patients constituted the study population. Mean patient age and duration post-RP at commencement of the rehabilitation program were 59 +/- 10 years and 7 +/- 3 months, respectively. Sixty-seven percent of operations were bilateral nerve sparing (BNS), 11% unilateral nerve sparing (NS), and 22% non-NS. Comorbidities included hypertension 22%, dyslipidemia 30%, coronary artery disease 7%, and diabetes 2%. Preoperative mean self-reported, partner-corroborated erectile rigidity during relations was 90 +/- 20%. At 18 months post-RP, 57% patients had partner-corroborated functional erections without phosphodiesterase type 5 inhibitors with a mean erectile rigidity during relations of 72 +/- 16% compared with 45 +/- 22% for those who denied functional erections postoperatively (P > 0.01). The IIEF-EF domain scores in these two cohorts were 21 +/- 7.5 and 13 +/- 9, respectively (P > 0.01). On multivariate analysis, factors that predicted failure of return of natural erections after RP having followed a rehabilitation program were age >60 years (relative risk [RR] = 1.3), non-BNS surgery (RR = 1.6), presence of >1 vascular comorbidity (RR = 2.1), commencement of rehabilitation >6 months post-RP (RR = 2.8), unsuccessful response to sildenafil at 12 months post-RP (RR = 4.5), and the use of trimix dose >50 units (RR = 8.1). CONCLUSIONS: More than half of the patients committing to a pharmacological rehabilitation program had return of functional natural erections. Predictors of successful outcome included NS surgery, early post-RP presentation, young age, and absence of vascular comorbidities.

Post-radical prostatectomy pharmacological penile rehabilitation: practice patterns among the international society for sexual medicine practitioners.

INTRODUCTION: Despite the fact that there is minimal evidence-based data supporting it, the concept of pharmacological penile rehabilitation following radical prostatectomy (RP) is receiving great attention. AIM: To define attitudes and practice patterns of clinicians who were members of the International Society for Sexual Medicine (ISSM) and/or its affiliated societies. METHODS: Members of the ISSM and its regional affiliates were invited to participate in a web-based survey. MAIN OUTCOME MEASURES: Demographic factors, current practice status, and opinions regarding post-RP erectile dysfunction and penile rehabilitation. The statistical methods used included chi-square, Student's t-tests, and logistic regression analysis. RESULTS: Three hundred-one physicians from 41 countries completed the questionnaire (82% were urologists). Sixty-five percent of the responders had formal sexual medicine specialty training, 44% had uro-oncology specialty training, and 60% performed RPs. Eighty-seven percent performed some form of rehabilitation. As part of the primary rehabilitation strategy, 95% used phosphodiesterase type 5 inhibitors (PDE5), 30% used vacuum device, 75% used intracavernosal injections, and 9.9% used intraurethral prostaglandin. Fifty-four percent commenced rehabilitation immediately/just after urethral catheter removal, and 37% within the first 4 months after RP. Neither the number of years in medical practice, clinician age, nor country/region of practice differed between rehabilitation performers and non-performers. With regard to the primary reason for avoiding rehabilitation: 50% responded said it is the cost; 25% said the fact that it is not evidence-based; and 25% said they were not familiar with the concept. Performing rehabilitation was positively associated with urologic oncology training (P = 0.03), performing RP (P < 0.001), and seeing over 50 post-RP patients per year (P = 0.011). CONCLUSIONS: Among ISSM members post-RP penile rehabilitation is widely practiced, commenced early, and based predominantly on PDE5 inhibitors and intracavernosal injections. Clinicians who perform RP or see over 50 such patients per year are the most likely to perform rehabilitation. Cost represents the most common reason for rehabilitation neglect.

[Vascular surgery, implant surgery and vacuum erectile aids. Review-overview-prospects of 3 therapy options in erectile dysfunction]. / Gefässchirurgie, Implantationschirurgie und Vakuumerektionshilfe. Rückblick-Uberblick-Ausblick dreier Therapieoptionen bei erektiler Dysfunktion.

Vascular surgery or penile prosthesis implantation are the main surgical options for erectile dysfunction. In this category, penile revascularization is the only causal therapy for selected patients: males younger than 50 years of age at time of surgery, maximum of two risk factors, exclusion of diabetes mellitus. Long-term success decreased to 53% to 55% in comparison to first encouraging reports of 80% success. Venous surgery resulted in an even more distinct decline of success the longer the elapse of time after surgery. Long-term success dropped under 40%, leaving only a few indications for penile venous ligation. In contrast, penile prosthesis implantation results in high satisfaction rates. Despite this, it is not generally recommended as first choice surgical management as it is linked to irreversible damage of the cavernosal bodies. Among numerous types of penile implants, preference is nowadays mostly given to the three-piece hydraulic models. However, such complications as defective or perforated cylinders in up to 35% after 5 years have arisen, depending on the type of implant. In a selected patient group, vacuum constriction devices with a mean patient acceptance of 75% (50% to 90%) seldom result in complications and are thus considered to be a well-established therapeutical option.

Epidemiology of current treatment for sexual dysfunction in spinal cord injured men in the USA model spinal cord injury centers.

This study is a prospective multicenter cooperative survey of the evaluation and treatment of erectile dysfunction in men with spinal cord injury (SCI). Uniform database questionnaires were completed prospectively by patients seeking therapy for erectile dysfunction. Eighty-five SCI men aged 17-68 years (mean age = 26 +/- 17) were enrolled. Mean duration of traumatic SCI was 3 +/- 3.2 years (Range = 0.3-18 years). The level of injury was cervical in 20 patients, thoracic in 31, lumbar in 29 and sacral in five. Patients were fully evaluated and then counseled as to their therapeutic options. Twenty-eight chose to use a vacuum erection device (VED), 26 preferred pharmacological penile injection and five used both intracorporeal therapy and VED. The remainder were managed with marriage and sexual counseling in 10 patients, three underwent penile prosthesis placement and two used topical pharmacotherapy. Four patients used other forms of treatment and in nine no therapy was recommended. Of the patients that used pharmacologic injection only, 74 percent used papaverine as a single agent, 20 percent used papaverine with phentolamine, five percent used prostaglandin E (PGE1) alone and one percent used a mixture. Patients using injection therapy report sexual intercourse a mean of 3 +/- 3.4 times per month as compared with 5 +/- 3.2 times per month in those using VED. Five intracorporeal injection patients developed priapism while two patients using the VED developed subcutaneous bleeding and one developed penile ischemia. We conclude that although a spectrum of erectile dysfunction treatment is present among SCI centers, VED and pharmacological penile injection are by far the two most popular methods of treatment and papaverine is the most common drug. The incidence of complications is small in the model centers.