Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial.

PURPOSE: Current penile traction therapy devices have significant limitations, including the need to use them for 3 to 8 hours per day. Given these issues, the novel RestoreX® penile traction therapy device was developed in cooperation with Mayo Clinic. MATERIALS AND METHODS: We performed a randomized, controlled, single-blind, intent to treat trial (ClinicalTrials.gov NCT03389854) in men with Peyronie's disease who were assigned to the penile traction therapy device for 30 to 90 minutes per day or to no therapy for 3 months. Study inclusion criteria were curvature 30 degrees or greater with no study exclusions due to complex curvature, hourglass deformity, prior Peyronie's disease therapy or surgery, or calcification. The primary outcome was safety and secondary outcomes were penile length and curvature, and questionnaire responses. RESULTS: A total of 110 men were randomized 3:1 to the penile traction therapy group or the control group. The cohorts were well matched with a mean age of 58.4 years, a 49.7-month Peyronie's disease history and 59.3 degree curvature. Overall penile traction therapy was well tolerated with only transient and mild adverse events reported. At 3 months men undergoing penile traction therapy demonstrated significant improvements over controls in penile length (1.5 vs 0 cm, p <0.001), curvature (-11.7 vs 1.3 degrees, p <0.01) and erectile function (4.3 vs -0.7, p = 0.01) according to the International Index of Erectile Function-Erectile Function among men with erectile dysfunction. Overall 77% of the men on penile traction therapy experienced improved curvature (mean -17.2 degrees in 28.2% of responders) while 94% achieved increased length (1.6 cm in 10.9%). Counter bending and the white line indicator improved efficacy, validating key device innovations. Of men who had previously used other penile traction therapy devices 100% preferred the RestoreX device. CONCLUSIONS: Penile traction therapy with the RestoreX device for 30 to 90 minutes per day was safe, and resulted in significant and clinically meaningful improvements in penile curvature and length in men with Peyronie's disease, and in erectile function in men with erectile dysfunction and Peyronie's disease with no significant adverse events. To our knowledge these data represent the only reported improvements for any device used less than 3 to 8 hours per day.

What about the partner? -factors associated with patient-perceived partner dyspareunia in men with Peyronie's disease.

BACKGROUND: Limited data are available on how partners of men with Peyronie's disease (PD) are affected by the disease. We sought to characterize PD patients whose curvatures result in pain for their partners during penetrative intercourse. METHODS: We queried a database of all men undergoing initial evaluation for PD at a single clinic between March 2014 and June 2016. Patients were administered a questionnaire regarding sexual health concerns with domains including erectile dysfunction, ejaculatory dysfunction, libido, and penile curvature. In the penile curvature section, patients were specifically asked: "Does the curvature cause your partner any pain during penetrative intercourse? (Y/N)." Patients' partners were not directly evaluated for conditions associated with dyspareunia. Additionally, patients interested in treatment for PD underwent objective curve assessment after intracavernosal injection of erectogenic medications along with penile duplex Doppler ultrasound. Statistical analysis was performed to identify differences in clinicopathologic variables and patient-responses to questionnaire prompts between patients who did and did not report partner pain with intercourse. RESULTS: A total of 322 patients with information available on partner pain were included in the study. Patients who reported partner pain had significantly higher subjective erectile rigidity (mean 5.9/10 vs. 4.8/10, P=0.02) and patient-reported penile curvature (47.7° vs. 33.3°, P<0.001) compared to those who did not report pain. Ventral curvatures were more common in men with partner pain (21% vs. 9% of men without, P<0.05). Furthermore, patients complaining of partner pain were more likely to report that PD had a negative impact on relationships and were more interested in pursuing surgical corrections. CONCLUSIONS: Men with superior erectile function, higher degrees of penile curvature and ventral curvatures were more likely to report partner pain during penetrative intercourse. These specific disease characteristics reported in this series may assist clinicians in identifying men who are more motivated to select more invasive therapies.

Office-based andrology and male infertility procedures-a cost-effective alternative.

BACKGROUND: From 2014-2016, our clinical practice progressively incorporated several male infertility and andrology procedures performed under local anesthesia, including circumcision, hydrocelectomy, malleable penile prostheses, orchiectomy, penile plication, spermatocelectomy, testicular prostheses, varicocelectomy, vasectomy reversal (VR), and testicular and microepididymal sperm aspiration (TESE/MESA). Given the observed outcomes and potential financial and logistical benefits of this approach for surgeons and patients, we sought to describe our initial experience. METHODS: A retrospective analysis was performed of all andrologic office-based (local anesthesia only) and select OR (general or monitored anesthesia care) procedures performed from 2014-2016. Financial and outcomes analyses were performed for infertility cases due to the homogeneity of payment modalities and number of cases available. Demographic, clinicopathologic, and procedural costs (direct and indirect) were reviewed and compared. RESULTS: A total of 32 VRs, 24 hydrocelectomies, 24 TESEs, 10 circumcisions, 9 MESA/TESEs, 4 spermatocelectomies, 3 orchiectomies (1 inguinal), 2 microTESEs, 2 testicular prostheses, 1 malleable penile prosthesis, 1 penile plication, and 1 varicocelectomy. Compared to the OR, male infertility procedures performed in the clinic with local anesthesia were performed for a fraction of the cost: MESA/TESE (78% reduction), TESE (89% reduction), and VR (62% reduction). All office-based procedures were completed successfully without significant modifications to technique. Outcomes were similar between the office and OR including operative time (VR: 181 vs. 190 min, P=0.34), rate of vasoepididymostomy (VE) (23% vs. 32%, P=0.56), total sperm counts (72.2 vs. 50.9 million, P=0.56), and successful sperm retrieval (MESA/TESE 100% vs. 100%, P=1.00; TESE 80% vs. 100%, P=0.36). To our knowledge, the current study also represents the first report of office-based VE under local anesthesia alone. For hydrocelectomy procedures, recurrence (4%) and hematoma (4%) rates were low (mean 4.2 months follow-up), although this likely relates to modifications with technique and not the anesthesia or operative setting. Overall, when given the choice, 86% of patients chose an office-based approach over the OR. CONCLUSIONS: Office-based andrology procedures using local anesthesia may be successfully performed without compromising surgical technique or outcomes. This approach significantly reduces costs for patients and the overall healthcare system and has become our treatment modality of choice.