Have you read? Best of the best: clinical research

Bruno Jorge Pereira
Urology Department of Centro Hospitalar e Universitário Cova da Beira (CHUCB)
and Health Sciences Faculty of the University of Beira Interior (FCS-UBI)
Covilhã, Portugal


Herbert K, Kohler TS. Acute Post-Inflatable Penile Prosthesis Glans Ischemia: Review of Incidence, Pathophysiology, and Management Recommendations. J Sex Med 2019; 16: 1-4.
In this invited commentary Kevin Herbert and Tobi Kohler provide a review of incidence, pathophysiology, presurgical considerations, and management recommendations for glans ischemia immediately after IPP implantation. The rarity of glans ischemia, combined with the disastrous permanent damage, likely produced a significantly underreported complication (fewer than 25 cases). Surgeons managing post-IPP glans ischemia must understand that they are not deciding between conservative or surgical management but rather when they will perform surgical management. Immediate removal of the device markedly increases the likelihood of glans salvage, whereas delaying device explantation will almost certainly be at the expense of tissue loss. “When in doubt, take it out!”

Neuville P, Morel-Journel N, Cabelguenne D, et al. First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty. J Sex Med 2019; 16: 316-322.
The ZSI 475FtM is a new prosthesis that has recently been specifically designed for phalloplasty. It has several functions that have been conceived to answer the challenges of implantation after phalloplasty: a large base for pubic bone fixation, realistically shaped hard glans, and a pump shaped like a testicle. Surgical outcomes were analyzed after implantation of the prosthesis between June 2016 and September 2017 (single institution, single surgeon). 20 patients who had gender dysphoria and underwent operation for a female-to-male procedure were included. The mean age was 37.9 years. Complications after 21 implantations included 2 (9.5 %) infections that were medically treated (Clavien II), 1 (4.7 %) infection treated by explantation (Clavien IIIb), 2 (9.5 %) mechanical failures (Clavien IIIb), and 1 (4.7 %) malpositioning (Clavien IIIb). The mean follow-up was 8.9 months (SD 4.0), with 50 % of the implanted patients having >12 months of follow-up. 14 patients (70 %) answered the satisfaction questionnaire. 12 patients (85.7 %) had regular penetrative sexual intercourse. The mean IIEF-5 score was 20.2 of 25, the mean Self-Esteem and Relationship score was 84.5 of 100, and the mean Erectile Dysfunction Inventory of Treatment Satisfaction score was 82 of 100. 13 patients (92.8 %) were satisfied or very satisfied with the prosthesis. This new innovative prosthesis could better answer the challenges faced by the implantation of an erectile device by phalloplasty. Preliminary results for the ZSI 475 FtM are encouraging. Safety seems to be satisfactory, and patient satisfaction is high.

Le BV, McVary KT, McKenna K, et al. Use of Magnetic Induction to Activate a “Touchless” Shape Memory Alloy Implantable Penile Prosthesis. J Sex Med 2019; 16: 596-601.
A novel physiologic penile prosthesis that uses shape memory alloy properties to mimic the transition between a flaccid and erect penis using magnetic induction instead of hydraulic pressure is described. The authors prototyped an implantable penile prosthesis cylinder using temperature-tuned nickel titanium alloy tubes laser cut to specifications. The device was then tested implanted in an animal tissue model and in cadaveric tissue. Testing consisted of placing the device deactivated in its more malleable and compressed state, then activating it using an external inducer wand while measuring temperature changes that occur on the surface of the device, within the tissue, and at the skin surface. Using a handheld magnetic inductor, the SMA penile prosthesis was successfully activated with no direct contact under 45 seconds. This handheld wand produced a magnetic field that penetrated tissue and caused the appropriate phase change within the prosthesis. The fully activated device resisted buckling forces of 2.66 kgf ± 0.045. This non-hydraulic shape memory prosthesis obviates the needs for reservoirs and pumps, and the wand-based interaction with the device may be easier to use. It appears to show thermal safety in controlled environments, however real-world use would need further studies. In conclusion, a shape memory penile prosthesis is a promising alternative to hydraulic-based penile prostheses and can be activated safely and efficiently using magnetic induction in our models of the human penis.

Male cardiovascular health

Isiozor NM, Kunutsor SK, Laukkanen T, Kauhanen J and Laukkanen JA. Marriage Dissatisfaction and the Risk of Sudden Cardiac Death Among Men. Am J Cardiol 2019; 123: 7−11.
Conflicts in marriage have been associated with potential risk of cardiovascular disease; however, there is lack of prospective evidence on the association between marriage satisfaction and sudden cardiac death (SCD). The authors of this study aimed to assess the association between perceived level of marriage satisfaction and risk of SCD. This study employed the Kuopio Ischemic Heart Disease study, an ongoing prospective population-based study in Finland. Perceived level of marriage satisfaction was assessed in 2.262 men using a well-structured self-administered questionnaire. During a median follow-up period of 25.9 years, 239 SCDs were recorded. The mean age of participants was 53 (SD 5.2) years. On adjustment for several conventional cardiovascular risk factors, hazard ratio (95 % CI) of SCD was 1.90 (CI 1.09 to 3.32; p = 0.02) for men who were dissatisfied with their marriage, compared with men who were satisfied with their marriage. The association remained consistent on further adjustment for preexisting coronary heart disease, socioeconomic status, and years of education 1.86 (CI 1.07 to 3.25; p = 0.03). In conclusion, middle-aged Caucasian men who are dissatisfied in their marriages should be regarded as a high-risk group when compared with men in very satisfied marriages, independent of conventional cardiovascular risk factors.

Erectile function

Limoncin E, Gravina GL, Lotti F et al. The Masturbation Erection Index (MEI): Validation of a New Psychometric Tool, Derived from the Six-Item Version of the International Index of Erectile Function (IIEF-6) and from the Erection Hardness Score (EHS), for Measuring Erectile Function During Masturbation. BJU Int. 2019 Mar; 123(3): 530-537.
To validate a psychometric instrument, the Masturbation Erection Index (MEI) able to evaluate erectile function (EF) during masturbation. In fact, although the evaluation of EF during masturbation is pivotal in evaluating erectile dysfunction (ED), to date no specific psychometric tools have been developed to measure it both in the routine clinical practice and in the experimental setting. 99 men with ED were compared 102 sexually healthy men. All the men were requested to complete both the six-item version of the International Index of Erectile Function (IIEF-6) and the MEI. Internal consistency of the MEI was >0.93. Test-retest reliability was 0.982 (95 % confidence interval [CI] 0.975-0.987). Bland-Altman analysis showed a good level of agreement between the IIEF-6 and MEI in the whole ED population, with stronger agreement in the organic-ED subpopulation. The estimated area under the curve of the MEI was 0.983 (P < 0.001; 95 % CI 0.954-0.996), with a score of ≤27 as the optimal threshold to discriminate between the presence and absence of ED during self-induced masturbation. In conclusion, MEI showed good internal consistency and a good level of agreement with the IIEF-6. Hence, the MEI fulfills the major psychometric requirements for measuring EF during masturbation.

Foy CG, Newman JC, Berlowitz DR, et al. Blood Pressure, Sexual Activity, and Erectile Function in Hypertensive Men: Baseline Findings from the Systolic Blood Pressure Intervention Trial (SPRINT). J Sex Med 2019; 16: 235-247.
Erectile function, an important aspect of quality of life, is gaining increased research and clinical attention in older men with hypertension. This study aimed to assess the cross-sectional association between blood pressure measures (systolic blood pressure [SBP]; diastolic blood pressure [DBP]; and pulse pressure [PP]) and (i) sexual activity and (ii) erectile function in hypertensive men. 1.255 male participants in a larger randomized clinical trial of 9.361 men and women with hypertension aged >50 years were analyzed. 857 participants (68.3 %) reported being sexually active during the previous 4 weeks. The mean (SD) IIEF-5 score for sexually active participants was 18.0 (5.8), and 59.9 % of the sample reported an IIEF-5 score <21, suggesting erectile dysfunction (ED). In adjusted logistic regression models, neither SBP nor DBP was significantly associated with sexual activity. In multivariable linear regression analyses in sexually active participants, lower SBP and higher DBP were associated with better erectile function. In additional multivariable analyses, lower PP pressure was associated with better erectile function. Erectile dysfunction was highly prevalent in this sample of men with hypertension, and SBP, DBP, and PP were associated with erectile function in this sample. Blood pressure is an important consideration in the assessment of erectile function in men with hypertension.

Erectile dysfunction

Grubbs JB, Gola M. Is Pornography Use Related to Erectile Functioning? Results From Cross-Sectional and Latent Growth Curve Analyses. J Sex Med 2019; 16: 111-125.
Despite evidence to the contrary, a number of advocacy and self-help groups persist in claiming that internet pornography use is driving an epidemic of erectile dysfunction (ED). This work sought to explore whether mere pornography use itself and self-reported problematic use of pornography are related to ED, both cross-sectionally and longitudinally. A series of 3 samples of sexually active men who also used pornography were collected. Across all 3 samples, there was evidence of a positive, cross-sectional association between self-reported problematic use and ED, but no consistent association between mere use itself and ED. These results suggest that among non-treatment-seeking pornography users, self-reported problematic use likely is associated with concurrent reports of ED, but that the links between these variables are not directional or causal in nature.

Rhim HC, Kim MS, Park Y-J, et al. The Potential Role of Arginine Supplements on Erectile Dysfunction: A Systemic Review and Meta-Analysis. J Sex Med 2019; 16: 223-234
This meta-analysis aimed to assess the efficacy and safety of arginine supplements in erectile dysfunction (ED). Studies compared arginine supplements with placebo or no treatment, focusing only on patients with mild to moderate severity of ED. In total, 10 randomized controlled trials met the inclusion criteria, reporting the outcomes of 540 patients with ED. The analysis demonstrated that arginine supplements with dosage ranging from 1.500 to 5.000 mg significantly improved ED compared with placebo or no treatment. Arginine supplements also caused significant improvements in the IIEF subdomain scores of overall satisfaction, intercourse satisfaction, orgasmic function, and erectile function, whereas the IIEF sexual desire score remain unchanged. The results of this systematic review and meta-analysis provide evidence on the effectiveness of arginine supplements for mild to moderate ED.

Peyronie’s disease

Moncada I, Krishnappa P, Romero J, Torremade J et al. Penile Traction Therapy with the New Device ‘Penimaster PRO’ is Effective and Safe in the Stable Phase of Peyronie’s Disease: A Controlled Multicentre Study. BJU Int. 2019; 123(4): 694-702.
To evaluate the efficacy and safety of a new penile traction device (PTD) in a group of patients with stable Peyronie’s disease (PD) compared with a non-intervention group in a multicentre study. A total of 93 patients with chronic stable PD (without erectile dysfunction, with no significant pain, and with a unidirectional curvature of at least 45° being stable for > 3 months) were recruited and followed for a 12-week period. Of these patients, 47 were randomly assigned to the PTD group (PG) and 46 to the non-intervention group (NIG). Patients were asked to apply the PTD 3-8 h a day for 12 consecutive weeks, with specific instructions regarding the progressive increase of traction force applied to the penis over time. The primary outcome of the study was the change in the degree of curvature measured in the fully erect state after intracavernosal injection of alprostadil at baseline, 1, 2 and 3 months. 41 patients in the PG and 39 in the NIG completed the study. There was an overall reduction in curvature of 31.2° (P < 0.001) at 12 weeks compared to baseline in the PG, representing a 41.1 % improvement from baseline, which significantly correlated with the number of daily hours the device was applied in a dose-dependent manner. Those patients using the device < 4 h/day experienced a reduction of 15°-25° (mean 19.7°, 28.8 % improvement; P < 0.05), while patients using the device > 6 h/day experienced greater curvature reduction, ranging from 20° to 50° (mean of 38.4°, 51.4 % improvement; P < 0.001). In contrast, no significant changes in curvature were observed in the NIG. Mild AEs occurred in 43 % of patients, such as local discomfort and glans numbness. In conclusion, the use of the PTD, a non-invasive treatment, should be offered to patients with stable PD for 3 consecutive months before performing any corrective surgery, as this provided a significant reduction in the curvature, an increase in penile length and a significant improvement of the symptoms and bother induced by PD.

Penile fracture

Rodriguez D, Li K, Apoj M, et al. Epidemiology of Penile Fractures in United States Emergency Departments: Access to Care Disparities May Lead to Suboptimal Outcomes. J Sex Med 2019; 16: 248-256.
The epidemiology of penile fractures in the emergency setting is not well described. Authors have examined the incidence, evaluation, management, risk factors predicting surgical repair or hospital transfer, and use of financial resources in patients presenting with penile fractures to the emergency departments (ED) nationwide in the Unites States. ED visits with a primary diagnosis of penile fractures between 2010-2014 were abstracted from the Nationwide Emergency Department Sample. 8.029 ED visits for penile fracture in the US were observed, which represents a national incidence of 1.02 per 100.000 male subjects per year. 63.9 % were treated non-surgically or discharged from the ED, 25.7 % underwent surgical repair, and 10.3 % were transferred to other institutions. Hospital factors which predicted surgical repair included Northeast region, teaching hospital status, trauma hospital status, high volume ED, and urban location. Clinical risk factors which predicted surgical repair included hypertension, smoking, alcohol dependence, drug abuse, erectile dysfunction, hematuria, urethral injury, and urinary retention. Factors leading to patient transfers included non-academic, rural and non-trauma hospitals, low economic income and low emergency department volume. In addition, weekend and spring presentation were associated with higher transfer rates, while summer presentation was associated with surgical repair. Clinical Implications: A large proportion of penile fractures are discharged from the ED, indicating possible health care access disparity. In conclusion, this large retrospective study of penile fractures in the US ED setting demonstrates a stable incidence of penile fractures presenting to the US emergency departments. A quarter of patients undergo immediate surgical repair, 10 % are transferred to other institutions and 63.9 % of patients are discharged home. The high proportion of ED discharges may be due to access to health care disparities.


Capogrosso P, Vertosick EA, Benfante NE et al. Are We Improving Erectile Function Recovery After Radical Prostatectomy? Analysis of Patients Treated over the Last Decade. Eur Urol. 2019; 75(2): 221-228.
The last decade has seen several advances in radical prostatectomy (RP) technique and post-RP care that are relevant to erectile function (EF) recovery. The authors examined whether these practice changes have led to observed improvements in EF rates over time. 2364 patients treated with either open or minimally-invasive RP at a single academic center in 2008–2015. To mitigate confounding by the surgical learning curve, only patients treated by surgeons who performed at least 100 procedures were considered. EF before and after RP was assessed by IIEF-6, with recovery defined as IIEF-6≥24.
EF recovery rates of patients treated with bilateral nerve-sparing surgery and free from adjuvant/salvage treatment at the time of EF assessment were analyzed. a significant decrease over time of the EF recovery rates at both 12 and 24 mo post-RP (all p = 0.01) was observed. In conclusion, findings from a high-volume center suggest that, despite the advancements in surgical and postoperative care, EF outcomes after RP have not improved over the last decade. Additional strategies are required to improve EF recovery after RP.

Nascimento B, Miranda EP, Jenkins LC, et al. Testosterone Recovery Profiles After Cessation of Androgen Deprivation Therapy for Prostate Cancer. J Sex Med 2019; 16: 872-879.
Androgen deprivation therapy (ADT) is frequently used in the treatment of prostate cancer worldwide. Variable testosterone (T) recovery profiles after ADT cessation have been cited. Serum early morning total T (TT) levels, collected at baseline and periodically after ADT cessation, were analyzed. Patient age, baseline T level, duration of ADT, and presence of diabetes and sleep apnea were selected as potential predictors of T recovery. 307 men with a mean age of 65 ± 8 years were included. Mean duration of ADT was 17 ± 25 months, and median follow-up was 31 ± 35 months. Mean TT values were 379 ng/dL at baseline and 321 ng/dL at >24 months. At 24 months after cessation of ADT, 8 % of men remained at castrate level, 76 % returned to TT >300 ng/dL, and 51 % had returned back to baseline. Lower baseline T levels (TT < 400 ng/dL) and ADT duration >6 months were associated with a lower likelihood of recovery to normal TT at 24 months. Age >65 years and receiving ADT for >6 months were significantly associated with a slower T recovery. T recovery after ADT is not certain and may take longer than expected. T recovery rates after ADT cessation vary according to patient age, ADT duration, and baseline T levels. Approximately one-quarter of patients failed to normalize their TT level, and one-tenth of men remained at castrate levels 24 months after ADT cessation. Considering the range of side effects of low T, these findings must be discussed with patients before initiating such therapies.

Almont T, Bouhnik A-D, Charif AB, et al. Sexual Health Problems and Discussion in Colorectal Cancer Patients Two Years After Diagnosis: A National Cross-Sectional Study. J Sex Med 2019; 16: 96-110.
Colorectal cancer (CRC) is accompanied by specific treatment-related physical (ostomy, incontinence) and psychosexual (body image, depression) consequences on sexual health. This study aimed to assess sexual health of patients from a French nationwide longitudinal study with CRC 2 years after diagnosis (n=487, 258 men and 229 women, 77 % colon cancer and 23 % rectal cancer). Overall, 54 % of patients reported a decrease in sexual desire, 61 % a decrease in frequency of intercourse, and 48 % a decrease in the possibility to reach an orgasm. Patients with rectal cancer had significantly more frequent troubles with desire and orgasm than did patients with colon cancer. Patients still experiencing fecal incontinence 2 years after diagnosis had decreases in all sexual desire, intercourse, orgasm, and satisfaction. Regarding the discussion about sexuality, only 20 % of men, 11 % of women, 11 % of patients with colon cancer, and 33 % of patients with rectal cancer recalled having discussed sexuality with the medical team. Factors independently increasing the chance to have discussed sexuality with the medical team were younger age, having an ostomy, and radiotherapy. This study highlights the lack of discussion about sexuality with the oncology team and the need for specific sexual rehabilitation interventions, especially for patients with rectal cancer and fecal incontinence. Developing these aspects may help patients with CRC improve their sexual prognosis.


Bolmont M, Bianchi-Demicheli F, Boisgontier MP, et al. The Woman’s Body (Not the Man’s One) Is Used to Evaluate Sexual Desire: An Eye-Tracking Study of Automatic Visual Attention. J Sex Med 2019; 16: 195-202.
Vision of the human body has been shown to be key in eliciting sexual desire. However, whether the visual pattern characterizing sexual desire is different in women and men is still unclear. Heterosexual healthy women and men (n=106) were tested on a picture-viewing task associated with eye tracking. The context of sexual desire was activated by asking the participant whether they perceived such desire while looking at sensual pictures of heterosexual couples. 2 areas of interest were created to investigate visual patterns (face vs. body area). Results showed longer fixations on body rather than face areas irrespective of participant gender. Moreover, all participants looked longer at women’s than men’s bodies and at the faces of the opposite sex. These findings confirm the association between the human body and sexual desire. They also reveal the unique attentional attractiveness of woman’s bodies across genders.