Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial.

BACKGROUND: Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. METHODS/DESIGN: Men with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment. DISCUSSION: A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.

The TiLOOP® Male Sling: Did We Forejudge.

INTRODUCTION: To evaluate the safety and efficacy of the TiLOOP® male sling (pfm medical, Cologne, Germany) used in the treatment for male stress urinary incontinence (SUI). MATERIAL AND METHODS: We retrospectively evaluated a total of 34 patients with a TiLOOP® male sling. Perioperative complication rates were assessed and validated questionnaires were prospectively evaluated to assess quality of life and satisfaction rate. Outcome and complication rates were analysed by using descriptive statistics. Correlation of continence outcome and risk factors was performed with the chi-square test. A p value below 0.05 was considered statistically significant. RESULTS: The majority of patients (70.6%) were diagnosed with mild or moderate male SUI. During surgery, one instance (2.9%) of intraoperative urethral injury was observed. There were no immediate postoperative complications. The mean follow-up time was 44.6 months. An improvement of male SUI was reported by 61.9% of the patients and 38.1% reported no change according the Patient Global Impression of Improvement. The mean perineal pain score was 0.5 according to the international index of pain. CONCLUSIONS: The TiLOOP® is a safe treatment option for male SUI in our cohort with a low complication rate. However, the functional outcome of the TiLOOP® was inferior when compared to the outcome of the AdVance® male sling.

Minimally invasive prostatic urethral lift: surgical technique and multinational experience.

BACKGROUND: Many men with benign prostatic hyperplasia (BPH) are dissatisfied with current treatment options. Although transurethral resection of the prostate (TURP) remains the gold standard, many patients seek a less invasive alternative. OBJECTIVE: We describe the surgical technique and results of a novel minimally invasive implant procedure that offers symptom relief and improved voiding flow in an international series of patients. DESIGN, SETTING, AND PARTICIPANTS: A total of 102 men with symptomatic BPH were consecutively treated at seven centers across five countries. Patients were evaluated up to a median follow-up of 1 yr postprocedure. Average age, prostate size, and International Prostate Symptom Score (IPSS) were 68 yr, 48 cm(3), and 23, respectively. SURGICAL PROCEDURE: The prostatic urethral lift mechanically opens the prostatic urethra with UroLift implants that are placed transurethrally under cystoscopic visualization, thereby separating the encroaching prostatic lobes. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients were evaluated pre- and postoperatively by the IPSS, Quality-of-Life (QOL) scale, Benign Prostatic Hyperplasia Impact Index, maximum flow rate (Qmax), and adverse event reports including sexual function. RESULTS AND LIMITATIONS: All procedures were completed successfully with a mean of 4.5 implants without serious adverse effects. Patients experienced symptom relief by 2 wk that was sustained to 12 mo. Mean IPSS, QOL, and Qmax improved 36%, 39%, and 38% by 2 wk, and 52%, 53%, and 51% at 12 mo (p<0.001), respectively. Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation. A total of 6.5% of patients progressed to TURP without complication. Study limitations include the retrospective single-arm nature and the modest patient number. CONCLUSIONS: Prostatic urethral lift has promise for BPH. It is minimally invasive, can be done under local anesthesia, does not appear to cause retrograde ejaculation, and improves symptoms and voiding flow. This study corroborates prior published results. Larger series with randomisation, comparator treatments, and longer follow-up are underway.

Efficacy of the InVance™ male sling in treating stress urinary incontinence: a three-year experience from a single centre.

INTRODUCTION: The aim of this study was to evaluate the efficacy of the InVance™ male sling in treating stress urinary incontinence. PATIENTS AND METHODS: We retrospectively reviewed operative logs from a single surgeon of 43 patients treated over a 3-year period (Feb. 2004 to Nov. 2006) for stress incontinence by implantation of a male bulbourethral bone-anchoring sling (InVance™). The mean follow-up time was 24.2 months (range 4-38). Radical prostatectomy was the most common cause of incontinence in this group (33/ 43 cases; 76.7%). Efficacy was evaluated objectively in terms of the number of pads used per day, while subjective patient satisfaction was also recorded. We also investigated a possible correlation between preoperative parameters and outcome. RESULTS: Twenty-two patients (51.2%) were cured (totally dry: 30.2%; the remainder: 1 pad per day), while 8 (18.6%) patients improved but still required two pads per day. Overall, 30 of 43 patients (69.6%) were satisfied with the outcome of the operation. Postoperative infection was the most common complication (11.6%). The severity of preoperative incontinence correlated with the outcome of the operation, with mild incontinence giving better results. CONCLUSIONS: The bone-anchored male sling is an effective and minimally invasive treatment for mild-to-moderate male urinary incontinence.

[Transurethral electrosurgery of a new generation (TURis) in the treatment of the lower urinary tract and prostate diseases].

Surgical interventions were made in 175 patients aged 23-87 years (mean age 64.8 years) with different diseases of the lower urinary tract (adenoma, prostatic cancer, cancer of the urinary bladder, etc.) with application of a new generation of endoscopic technique--transurethral resection in saline (TURis system) with a generator UES-40 SurgMaster (Olympus). Three patients had a cardiac pacemaker. The size of the prostate in prostatic adenoma ranged from 4.8 to 121 cm3 (mean 62.5 cm3), residual urine--92.3 ml (42.6 to 310.2 ml). Duration of surgery averaged 63 min (14 to 127 min). Mean amount of the resected tissue in sclerosis of urinary bladder cervix was 7 g (5-11 g), in prostatic adenoma--41 g (10-85 g), prostatic cancer--27 g (17-49 g). In postoperative period tamponade of the urinary bladder developed in 2 (1.5%) patients. Red cell transfusions were not necessary. Incontinence was observed in 7 (5.3%) patients after removal of urethral catheter, in 5 (3.8%) patients it stopped spontaneously to the time of discharge from the hospital, 2 (1.5%) patients with prostatic cancer retained partial orthostatic incontinence. TURis raised Qmax from 8.1 to 19.8 ml/s, on the average. The scores by IPSS fell from 20.8 to 7.5, QoL--from 5.1 to 3.7, on the average. Residual urine after operation reached 35 ml maximum. Informative value of histological material rose significantly in view of a minimal zone of coagulatory changes in the samples. Standard time limitation for transurethral resection (60-90 min) becomes insignificant in using isotonic irrigation allowing urologists to resect safely larger adenomas than it was possible earlier.