Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study).

BACKGROUND: Patient outcomes were assessed 2 years after treatment with the Optilume BPH Catheter System, a minimally invasive surgical therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). METHODS: One-hundred forty-eight adult males with symptomatic BPH were enrolled and randomized in a 2:1 fashion to Optilume BPH or Sham (100 Optilume BPH; 48 Sham). Long-term measures include International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), Post-Void Residual Urine (PVR), quality of life measures and sexual function. Follow-up beyond one year was limited to those treated with Optilume BPH. RESULTS: At 2 years, 67.5% (56/83 CI 56.3%, 77.4%) of participants in the Optilume BPH arm were symptomatic responders as defined by ≥30% improvement in IPSS without medical or surgical retreatment. IPSS significantly improved from 23.4 ± 5.5 (n = 100) to 11.0 ± 7.0 (n = 74). Qmax improved by 116.8.% (8.9 ± 2.2 (n = 97) to 19.0 ± 16.3 (n = 65)), while PVR showed a slight reduction (83.7 ± 70.3 (n = 99) to 65.9 ± 74.5 (n = 65)). Improvement in uroflowmetry measures was consistent across all prostate volumes. BPH-II improved from 7.0 ± 2.9 (n = 98) to 2.3 ± 2.5 at 1 year (n = 89) and remained consistent at 2.3 ± 2.9 at the 2-years (n = 74), representing a 53.9% improvement. IPSS QoL also improved from 4.6 ± 1.3 (n = 100) at baseline to 2.2 ± 1.5 (n = 74). The most common adverse events reported in the Optilume BPH arm were hematuria and urinary tract infection (UTI). No device and/or treatment related serious adverse events were reported occurring beyond 12 months post-procedure. There was no impact to sexual function. CONCLUSIONS: In the PINNACLE study, participants treated with the Optilume BPH Catheter System demonstrated continued and durable results at 2 years, affirming tolerability, safety, and the enduring effectiveness. The Optilume BPH Catheter System provides lasting results that are comparable to the more invasive therapies, while preserving the advantages with being a minimally invasive therapy. REGISTRATION: ClinicalTrials.gov NCT04131907.

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure. MATERIALS AND METHODS: Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments. RESULTS: A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%). CONCLUSIONS: Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.

Male adolescent fertility preservation.

Until the 1960s, few adolescents and young adults (AYAs) survived their initial cancer diagnoses. Now, ∼12,400 AYA patients are diagnosed with cancer each year, and almost 80% will now achieve a long-term cure. This dramatic improvement in survival is primarily due to multimodal treatments and combined chemotherapeutic regimens. Unfortunately, the increase in survival is often accompanied by treatment-related toxicities due to chemotherapy, radiation therapy, and surgical procedures. Despite guidelines published by the American Society of Clinical Oncology and numerous other professional organizations, high percentages of male AYA oncology patients are not properly counseled regarding their fertility preservation options before cancer treatment. Although administering fertility preservation care to adolescent males can be challenging in many ways, numerous studies show that this care can be delivered with high degrees of success and high levels of patient and parent satisfaction. The key to this success at many institutions has been the implementation of formalized integrated fertility preservation programs with infrastructure geared toward the delivery of comprehensive expedited care.

Ability of community-based prostate cancer screening to target an appropriate and underserved population.

Screening is not universally beneficial due to over- and under-diagnosis, and false positives that beget additional testing and associated adverse events and expense. We examined data from all men who participated in a mass community prostate cancer screening between May 2009 and September 2010. The data contained information regarding patient demographics, family history of prostate cancer, lower urinary tract symptoms, prior history of prostate cancer, most recent digital rectal examination, and the presence of an established relationship with a physician. Current American Urological Association screening recommendations were then applied to determine the appropriateness of our outreach effort. A total of 438 men (mean age 66.5 years) underwent screening. A total of 106 (24.2%) patients in our study met contemporary criteria for screening. Of these men, the vast majority was well educated, well insured, and well informed about the need for prostate cancer screening. Based on these data, mass community-based prostate cancer screening does not appear to identify and screen at-risk men. Future efforts at mass screening should more carefully target men most likely to benefit.

Effect of rejuvenation hormones on spermatogenesis.

OBJECTIVE: To review the current literature for the effect of hormones used in rejuvenation clinics on the maintenance of spermatogenesis. DESIGN: Review of published literature. SETTING: Not applicable. PATIENT(S): Men who have undergone exogenous testosterone (T) and/or anabolic androgenic steroid (AAS) therapies. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Semen analysis, pregnancy outcomes, and time to recovery of spermatogenesis. RESULT(S): Exogenous testosterone and anabolic androgenic steroids suppress intratesticular testosterone production, which may lead to azoospermia or severe oligozoospermia. Therapies that protect spermatogenesis involve human chorionic gonadotropin (hCG) therapy and selective estrogen receptor modulators (SERMs). The studies examining the effect of human growth hormone (HGH) on infertile men are uncontrolled and unconvincing, but they do not appear to negatively impact spermatogenesis. At present, routine use of aromatase inhibitors is not recommended based on a lack of long-term data. CONCLUSION(S): The use of hormones for rejuvenation is increasing with the aging of the Baby Boomer population. Men desiring children at a later age may be unaware of the side-effect profile of hormones used at rejuvenation centers. Testosterone and anabolic androgenic steroids have well-established detrimental effects on spermatogenesis, but recovery may be possible with cessation. Clomiphene citrate, human growth hormone (HGH)/insulin-like growth factor-1 (IGF-1), human chorionic gonadotropin (hCG), and aromatase inhibitors do not appear to have significant negative effects on sperm production, but quality data are lacking.