Safety and efficacy of botulinum neurotoxin in the treatment of erectile dysfunction refractory to phosphodiesterase inhibitors: Results of a randomized controlled trial.

BACKGROUND: There has been recent interest in the use of botulinum neurotoxin (BoNT) in the field of Andrology, whereby it has been investigated in the treatment of penile retraction and premature ejaculation. OBJECTIVES: To evaluate the safety and efficacy of intracavernosal BoNT-A injection in the treatment of patients with erectile dysfunction (ED) refractory to oral phosphodiesterase inhibitors (PDE5Is). PATIENTS AND METHODS: A double-blind randomized placebo-controlled prospective comparative study conducted at one center and involved 70 patients with ED refractory to PDE5Is. At baseline, the following data were collected: erection hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), sexual health inventory for men (SHIM), and the sexual encounter profile 2&3 (SEP-2&3) questionnaires. Treatment group (n = 35) received a single ICI of 100 units of BoNT-A in 2 ml of saline and control group (n = 35) received a single ICI of 2 ml of saline. EHS, PSV, and EDV were assessed at 2 weeks post treatment. SHIM, SEP-2, SEP-3, and global assessment questionnaire (GAQ-Q1&Q2) were completed at 2-, 6-, and 12-weeks post treatment. RESULTS: Two weeks post treatment, the treatment group showed a statistically significant improvement in the mean EHS, PSV, EDV, and GAQ-Q1 positive responders (p < 0.001) compared to the control group. At 6- and 12-weeks post treatment, the treatment group showed a statistically significant improvement in the SHIM scores, SEP-2, and GAQ-Q1&Q2 positive responders compared to the control group. At 6 weeks, where there was a 5-point improvement in the mean SHIM score of the treatment group (10±5.9 from 5.4±1.7 at baseline) versus no improvement in the placebo group, 18 patients in the treatment group (53%) were able to have an erection hard enough for vaginal penetration versus only one patient in the control group. CONCLUSION: BoNT-A is safe and effective as a potential treatment for ED refractory to PDE5I therapy.

An Open Prospective Study on Whether Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Offers a Better Outcome Than Conventional Intracytoplasmic Sperm Injection (ICSI).

Objective To differentiate the in vitro fertilization (IVF) outcomes between the two procedures, intracytoplasmic morphologically selected sperm injection (IMSI) and intracytoplasmic sperm injection (ICSI) in terms of relation to chemical pregnancy percentage, clinical pregnancy, live birth, miscarriage, and fertilization rates, respectively. Patients and methods This Open Prospective clinical trial was conducted during the period between Jan 2016 and Dec 2017 at one IVF unit. A total of 446 ICSI cycles and 79 IMSI cycles were conducted. Females were divided into four subgroups according to age. Results The study involved 525 couples (446 first trial ICSI cycles) and (79 first trial IMSI cycles). ICSI was statistically better than the IMSI in relation to the chemical pregnancy, clinical pregnancy (CPR), live birth (LBR), and fertilization rates, respectively (p < 0.05). However, there were no statistically significant differences between the ICSI and IMSI in relation to the miscarriage rate. There were statistically significant differences favoring ICSI in all subgroups except 35-37, in relation to chemical pregnancy; and in the 38-40 and >40 subgroups in relation to CPR. There were no statistically significant differences in these subgroups regarding the live birth, miscarriage, or fertilization rates. Conclusions This study showed that IMSI is not superior to conventional ICSI at the first attempt. Based on the findings in this study, we would not advise couples to choose IMSI at their first treatment attempt.

Urethral instillation of chlorhexidine gel is an effective method of sterilisation.

Objective: To examine the effectiveness of preoperative urethral sterilisation with chlorhexidine gel in rendering the urethra as sterile as the skin of the genital area, with the skin sterilised as per the International Society for Sexual Medicine guidelines for penile prosthesis implantation. Patients and methods: A total of 111 male patients undergoing sterile andrological surgical procedures were divided into a control group (N = 61) and a chlorhexidine gel group (N = 50). Patients in the chlorhexidine group received urethral instillation with 6 mL of chlorhexidine preoperatively and on table. Patients from both groups received on-table skin preparation using povidone iodine and chlorhexidine povidone iodine. At the end of surgery, swabs were obtained from urethra and the penile skin. Skin and urethral swabs were compared for bacterial colonisation by culture and sensitivity. Results: Of the 111 patients, 16 had urethral colonisation and 10 had skin contamination, and they were all in the control group. The most common organism detected in both the urethral and skin samples was coagulase-negative Staphylococcus aureus. Urethral colonisation was significantly greater in the control group compared to the chlorhexidine group, at 16/61 vs 0/50 (P = 0.001). Similarly, skin colonisation was significantly greater in the control group compared to the chlorhexidine group, at 10/61 vs 0/50, (P = 0.002). Conclusion: Chlorhexidine gel is a powerful sterilising agent that will render the urethra sterile.

The Impact and Management of Gynaecomastia in Klinefelter Syndrome.

Gynecomastia is defined as a palpable enlargement of the male breast, secondary to an increase in the glandular and stromal breast tissue. Gynecomastia is encountered in up to 80% of Klinefelter syndrome cases. The pathophysiology involves testosterone/estrogen imbalance. This review article will further explore the pathophysiology of gynecomastia along with the different lines of management.

Botulinum Neurotoxin and Its Potential Role in the Treatment of Erectile Dysfunction.

INTRODUCTION: Botulinum toxin type A (BoNT-A) has been used to treat several striated and smooth muscle disorders. During the past year, human and animal studies conducted in Egypt and Canada by two different groups of investigators have suggested a possible role for the intracavernosal injection of BoNT-A in the treatment of erectile dysfunction (ED). AIM: To discuss BoNT-A and its current medical uses, the rationale for its new potential use in the treatment of ED, and the available evidence and concerns. METHODS: A literature search was conducted. This review was based on the available studies presented at the European Society for Sexual Medicine, Sexual Medicine Society of North America, and International Society for Sexual Medicine meetings in 2016 by the two groups. MAIN OUTCOME MEASURES: Sinusoidal diameter; penile color Doppler study; Erection Hardness Score; Sexual Health Inventory for Men questionnaire; and Sexual Encounter Profile questions 2 and 3. RESULTS: Two human studies conducted by the authors and two animal studies (one from the authors' group and one from Canada) were reviewed. These seemed to suggest generally favorable outcomes with the use of BoNT-A in the treatment of ED. CONCLUSION: BoNT-A could be a potential therapy for ED. In addition to the findings of the three pilot studies, larger multicenter trials need to be conducted to further explore the true therapeutic efficacy and clinical safety of BoNT-A in the treatment of ED. Ghanem H, Raheem AA, AbdelRahman IFS, et al. Botulinum Neurotoxin and Its Potential Role in the Treatment of Erectile Dysfunction. Sex Med Rev 2018;6:135-142.

Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease-A Review of the Literature and a New Modified Protocol.

INTRODUCTION: Peyronie's disease (PD) is a common condition that results in penile deformity, which makes sexual intercourse difficult or impossible, and causes psychological, emotional, and relationship difficulties for the man affected and his partner. Collagenase Clostridium histolyticum (CCH; Xiapex, Xiaflex) is the first licensed non-surgical treatment option for PD. The safety and efficacy have been demonstrated in two large phase III randomized controlled trials (IMPRESS I and IMPRESS II). AIM: To review the safety and efficacy of CCH and to introduce a new shortened modified protocol for CCH that was developed by the authors to decrease the cost and duration of treatment. METHODS: A review of the medical literature on CCH for inclusion in this review was obtained by searching the PubMed (from 1946) and Medline (from 1946) medical databases and from the screening of relevant bibliographies. The search terms Xiapex, Xiaflex, collagenase Clostridial histolyticum, and Peyronie's disease were used. Clinical trials in men with PD and scientific articles relating to pharmacologic data were included in the review. When possible, large, randomized, and well-designed trials were selected. MAIN OUTCOME MEASURES: Changes in the angle of penile curvature and in the Peyronie's Disease Questionnaire domains. RESULTS: The clinical trials demonstrate the safety and efficacy of CCH in the treatment of PD. The new modified protocol developed by the authors is as safe and effective as the protocol used in the clinical trials. CONCLUSION: CCH is the first licensed non-surgical treatment for PD. Its safety and efficacy have been demonstrated in large well-designed clinical trials. The new shortened modified protocol decreases the cost and duration of the treatment without compromising the safety and efficacy of the drug. This alteration will allow more patients to benefit from CCH. Abdel Raheem A, Johnson M, Abdel-Raheem T, et al. Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease-A Review of the Literature and a New Modified Protocol. Sex Med Rev 2017;5:529-535.

Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie's disease using a new modified shortened protocol.

OBJECTIVES: To evaluate the efficacy and safety of collagenase clostridium histolyticum (CCH; Xiapex® , Xiaflex® ) in the treatment of Peyronie's disease (PD) using a new modified treatment protocol that aims at reducing the number of injections needed and reducing patient visits, thus reducing the duration and cost of treatment. PATIENTS AND METHODS: A prospective study of 53 patients with PD who had treatment with CCH at a single centre using a new modified protocol. The angle of curvature assessment after an intracavernosal injection of prostaglandin E1, the International Index of Erectile Function (IIEF) and Peyronie's Disease Questionnaire (PDQ) were completed at baseline and at week 12 (4 weeks after the last injection). The Global Assessment of Peyronie's disease (GAPD) questionnaire was completed at week 12. Under a penile block of 10 mL plain lignocaine 1%, a total of three intralesional injections of CCH (0.9 mg) were given at 4-weekly intervals using a new modified injection technique. In between injections patients used a combination of home modelling, stretching and a vacuum device on a daily basis to mechanically stretch the plaque. Investigator modelling was not performed. RESULTS: The mean (range) penile curvature at baseline was 54 (30-90)°. Of the 53 patients in the study, 51 patients (96.2%) had an improvement in the angel of curvature by a mean (range) of 17.36 (0-40)° or 31.4 (0-57)% from baseline after three CCH injections. The final mean (range) curvature was 36.9 (12-75)° (P < 0.001). There was an improvement in each of the IIEF questionnaire domains, all three PDQ domains and the GAPD. CCH was well tolerated by all patients with only mild and transient local adverse events. CONCLUSION: The new shortened protocol using CCH treatment is safe, effective, and cost efficient. The results of using only three CCH injections according to this modified protocol are comparable to those of the clinical trials that used eight CCH injections.

Testicular histopathology as a predictor of a positive sperm retrieval in men with non-obstructive azoospermia.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: The management of patients with non-obstructive azoospermia (NOA) involves testicular sperm extraction (TESE or microdissection TESE) combined with intracytoplasmic sperm injection (ICSI). Sperm retrieval is successful in up to 50% of men with NOA; however, there is no single clinical finding or investigation that can accurately predict a positive outcome. Several studies have concluded that testicular biopsy is the best predictor of a successful TESE. The present study shows that the strongest predictor of the success of TESE is when tubules with mature spermatozoa (Johnsen score ≥8) are found in the histopathology specimen, irrespective of the overall state of spermatogenesis. The findings suggest that a lower limit threshold value of 2% of tubules with spermatogenesis in the histopathology specimen will result in a positive sperm retrieval. However, it is not practical to perform a diagnostic biopsy before TESE because this would mean that patients undergo two surgeries, which adds to the cost and increases the complications. The diagnostic biopsy is best coupled with an initial TESE before starting the ICSI cycle. Based on the findings of the histopathology specimen, patients may be then offered a repeat TESE if more sperm is needed on the day of ovum pick-up and ICSI. Also, if the initial TESE was negative, the biopsy result will help in the decision to offer a repeat TESE. This regimen is more cost-effective because the ICSI cycle will be started only if adequate sperm is retrieved. OBJECTIVE: To assess whether testicular histopathology can predict the outcome of testicular sperm extraction (TESE) in men with non-obstructive azoospermia (NOA) and therefore the role of preoperative diagnostic testis biopsy. PATIENTS AND METHODS: The study comprised a retrospective analysis of 388 patients with azoospermia who were referred from 2005 to 2010. Information collected included a clinical history and an examination including age and testicular size, serum follicle-stimulating hormone, two semen analyses and testicular histology collected at the time of surgical sperm retrieval (TESE or microdissection TESE). RESULTS: In total, 388 patients with a mean (range) age of 37 (18-66) years were included in the present study. Based on the history, clinical and laboratory findings, 112 patients had obstructive azoospermia and 276 patients had NOA. All patients in the obstructed group had a positive sperm retrieval. The sperm retrieval rate for the NOA group was 50%. An analysis of the results showed that the best predictor of a positive sperm retrieval was when tubules with mature spermatozoa were seen at biopsy, irrespective of the overall state of spermatogenesis (P < 0.001). CONCLUSIONS: The presence of tubules with spermatazoa on biospy is the best predictor of a positive surgical sperm retrieval in patients with NOA. The diagnostic biopsy is best coupled with an initial TESE before starting the intracytoplasmic sperm injection (ICSI) cycle. Based on the findings of the histopathology specimen, patients may be offered a repeat TESE if more sperm is needed on the day of ovum pick-up and ICSI, or a redo TESE if the initial TESE was negative.