Journal: The Journal of urology
Vascular targeted photodynamic therapy (VTP) with WST11 (TOOKAD(®) Soluble; STEBA Biotech, Luxembourg) is a form of tissue ablation that may be used therapeutically for localized prostate cancer (PCa). To study dosing parameters and associated treatment effects we undertook a prospective multicenter phase I/II trial of WST11 VTP for treatment of PCa METHODS: 30 men with unilateral, low volume, Gleason 3+3 PCa were enrolled at 5 centers following local IRB approval. Light energy, fiber number, and WST11 dose were escalated to identify optimal dosing parameters for VTP hemiablation. Men were treated by VTP and evaluated by post-treatment MRI and biopsy. PSA, light dose index (LDI -defined as sum of fiber length/ desired treatment volume), toxicity, and quality of life parameters were recorded.
PURPOSE: Men are particularly concerned about pain after circumcision. Concerns about pain can be a reason to decline surgery. Our aim was to assess the severity of postoperative pain and to investigate factors that may influence postoperative pain. MATERIALS AND METHODS: This was a prospective observational cohort study on patients undergoing circumcision. Patients were asked to fill in a questionnaire using visual analogue scales for pain (severity 0-10) on days 1,2,3,7, 21 and to record analgesia used, complications and time off work. Other data recorded were patient age, clinical indication of surgery, foreskin retractility, presence of adhesions and histology. RESULTS: 112 of 211 questionnaires were returned (53.1%). Mean age of patients was 46.4yrs. Commonest clinical indication for circumcision was phimosis (75%). Postoperative pain was scored as mild to moderate (means: 2.4 on days 1-3, 2.1 on day 7 and 0.5 on day 21). Patients younger than 35 yrs of age (p=0.025) and patients with wound infections (p=0.036) had higher pain scores. Only 11 patients (9.8%) had severe pains at any time during the recovery of which 8 had wound problems. The average time off work in the employed population was 6.6 days (SD-6.5), 5 days for light work and 11 days for heavy physical activity. CONCLUSION: Pain following adult circumcision under general anaesthetic administration with intra-operative penile block administration is mild to moderate. Severe pain is rare and mostly related to complications. Younger patients have more discomfort in general.
PURPOSE: To report the long-term efficacy and safety of PTNS with the Urgent® PC Neuromodulation System for OAB after three years of therapy. MATERIALS AND METHODS: Fifty participants in the randomized, double-blind SUmiT Trial who met the primary effectiveness endpoint after 12-weekly PTNS treatments were enrolled in this prospective study to assess long-term outcomes with PTNS. STEP patients were prescribed a fixed-schedule 14-week tapering protocol followed by a personal treatment plan aimed at sustaining OAB symptom improvement. OAB and quality-of-life questionnaires were completed everythree months andthree -day voiding diaries were completed everysix months. RESULTS: Twenty-nine patients completed the 36-month protocol and receiveda median of 1.1 treatments per month after a 14-week treatment tapering protocol. A Bayesian model estimated 77% (95% CI, 64%-90%) of patients maintained moderate or marked improvement in OAB symptoms at three years. Compared to baseline, median voids per day decreased from 12.0 (IQR, 10.3-13.7) to 8.7 (IQR, 7.3-11.3), nighttime voids per night decreased from 2.7 (IQR, 1.7-3.3) to 1.7 (IQR, 1.0-2.7), and urge incontinence episodes per day decreased from 3.3 (IQR, 0.7-6.0) to 0.3 (IQR, 0.0-1.0) (all p<0.0001). All quality of life parameters remained markedly improved from baseline through three years (all p<0.0001). One patient experienced two mild treatment-related adverse events ofbleeding at needle site during follow-up. CONCLUSIONS: Most STEP participants with an initial positive response to 12 weekly PTNS treatments safely sustained OAB symptom improvement to three years with an average of one treatment per month.
PURPOSE: The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies (IMPRESS) I and II examined the clinical efficacy and safety of collagenase clostridium histolyticum (CCH) intralesional injections in subjects with Peyronie’s disease (PD). Co-primary outcomes in these identical phase 3 randomized, double-blind, placebo-controlled studies included percent change in penile curvature deformity and change in Peyronie’s Disease Questionnaire PD symptom bother score from baseline to 52 weeks. MATERIALS AND METHODS: The IMPRESS I (N=417) and II (N=415) studies examined CCH intralesional injections through a maximum of 4 treatment cycles, each separated by 6 weeks. Subjects received up to 8 injections of 0.58 mg CCH, 2 injections per cycle separated by approximately 24-72 hours, with the second injection in each followed 24-72 hours later by penile plaque modeling. Subjects were stratified by degree of penile curvature at baseline (30-60° versus 61-90°) and randomized to CCH or placebo (2:1 in favor of CCH). RESULTS: From a post-hoc meta-analysis of IMPRESS I and II data, CCH-treated subjects showed a mean 34% improvement in penile curvature deformity, a mean -17.0±14.8° change per subject, compared with a mean 18.2% improvement in placebo-treated subjects, a mean -9.3±13.6° change per subject (p<0.0001). Mean change in PD symptom bother score was significantly improved in CCH-treated (-2.8±3.8) versus placebo (-1.8±3.5, p=0.0037) subjects. Three corporal rupture serious adverse events occurred and were all surgically repaired. CONCLUSIONS: The IMPRESS I and II studies support the clinical efficacy and safety of CCH treatment for both the physical and psychological aspects of PD.
The safety of using a ureteral access sheath during retrograde intrarenal surgery remains controversial. Using a novel classification, we prospectively evaluated the incidence and severity of ureteral access sheath driven ureteral wall injury after flexible ureteroscopy for retrograde intrarenal surgery.
In this study we prospectively investigated the contribution of restored penile sensation to sexual health in patients with low spinal lesions.
PURPOSE: Voluntary medical male circumcision (VMMC) has been shown to reduce men’s risk of HIV infection through heterosexual intercourse by ~60% in clinical trials and 73% in post-trial follow-up. In 2007, WHO and UNAIDS recommended countries with low circumcision rates and high HIV prevalence expand VMMC programs as part of their national HIV prevention strategies. Devices for adult/adolescent male circumcision could accelerate the pace of VMMC scale-up. Detailed penile measurements of African males are required for device development and supply size forecasting. MATERIALS AND METHODS: Consenting males undergoing VMMC at three health facilities in Tanzania’s Iringa region underwent measurement of the glans, shaft and foreskin of the penis. Age, Tanner stage, height and weight were recorded. Measurements were analyzed by age categories. Correlations between penile parameters and height, weight and body mass index (BMI) were calculated. RESULTS: In 253 Tanzanian males ages 10-47 years, the mean (SD) penile length of adults was 11.5 (1.6) cm; shaft circumference was 8.7 (0.9) cm; and glans circumference was 8.8 (0.9) cm. As expected, given the variability of puberty, measurements of younger males varied significantly. Glans circumference was highly correlated with height (r=0.80, p<.001) and weight (r=0.81, p<.001). Stretched foreskin diameter was moderately correlated with height (r=0.68, p<.001) and weight (r=0.71, p<.001). CONCLUSIONS: This descriptive study provides penile measurements of males seeking VMMC services in Iringa, Tanzania. It is the first study in a sub-Saharan African population that provides sufficiently detailed glans and foreskin dimensions to inform VMMC device development and size forecasting.
We evaluated the economic impact of preventing recurrent stones using a strategy of increased water intake and determined the impact of compliance on cost-effectiveness for the French health care system.
We present patient reported outcomes from our 5-year experience using penile plication to correct a wide variety of Peyronie disease malformations.
PURPOSE: To describe the long-term cancer control and morbidity of high intensity focused ultrasound (HIFU) with neoadjuvant transurethral resection of the prostate (TURP), the risk of metastatic induction by TURP and the evolution of HIFU application and technology over time. PATIENTS AND METHODS: Prospective Harlaching HIFU database was searched for patients with primary localized PCa (T1-2, N0, M0, PSAi <50 ng/ml) and follow-up > 15 months; those with previous long-term ADT, locally advanced PCa, or any PSA-influencing therapy were excluded. All patients were treated completely by Ablatherm® HIFU device. Evaluation was performed in aggregate and by stratification according to cohort group, risk group (D'Amico criteria), PSA Nadir, and Gleason score. Phoenix definition was used for biochemical failure. Statistical analysis was performed using the Kaplan-Meier method, univariate and multivariate analysis employing a Cox model. RESULTS: Of 704 study patients, 78.5% had intermediate- or high-risk disease. Mean follow-up was 5.3 (1.3-14) years. Cancer-specific survival was 99%, metastasis-free survival 95%, and 10-year salvage treatment-free rates were 98% in low-risk, 72% in intermediate-risk, and 68% in high-risk patients. PSA Nadir and Gleason score predicted biochemical failure, side effects showed to be moderate. HIFU retreatment rate was 15% since 2005. CONCLUSIONS: Long-term follow-up with HIFU therapy showed a high overall rate of cancer-specific survival and an exceptionally high rate of freedom from salvage therapy requirement in low-risk patients. Advances in HIFU technology and clinical practice and the use of neoadjuvant TURP allow complete treatment of any sized prostate without induction of metastasis.