Is artificial urinary sphincter surgery safe and effective in elderly males aged 70 years and above?

OBJECTIVES: To evaluate the clinical outcomes and patient satisfaction rate between men aged under and over 70 years who underwent artificial urinary sphincter (AUS) surgery. METHODS: A prospective review of all men who received AUS between January 2008 and January 2018 was undertaken with a minimum 24-month review. All patient demographics and surgical outcomes including data on the Incontinence Impact Questionnaire, Patient Global Impression of Improvement (PGI-I) and National Surgical Quality Improvement Program Frailty Index (NSQIP-FI) scores, as well as patient satisfaction rates, were recorded. RESULTS: Of the 245 AUS implanted, 60 patients were aged ≥70 years with 45 virgin cases and 15 revision AUS. Reduction in mean pad use and weight over 24 hours were significant at 0.21 (0-1) pads and 8 (0-30) g in both groups with no significant difference (P = 0.76). Kaplan-Meier estimates of AUS survival showed no significant difference between men aged ≥ and <70 years at 1 year (98% versus 96%; P = 0.44). The multivariate logistic regression model showed that radiation (adjusted odds ratio [OR] 3.8, 95% CI 1.4-6.8; P < 0.01) was a significant predictor of AUS revision, while age ≥ 70 years (adjusted OR 1.0, 95% CI 0.8-8.8; P = 0.14) and frailty (NSQIP-FI ≥ 0.27 adjusted OR 0.9, 95% CI 0.2-7.6; P = 0.82) were not. There were no significant differences in PGI-I scores (P = 0.43) and overall satisfaction rate (83% versus 84%; P = 0.44) between the two groups. CONCLUSIONS: Men aged ≥70 years reported similar clinical efficacy as men aged <70 years in terms of device survival and satisfaction rates following AUS surgery.

Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study.

INTRODUCTION: Low intensity extracorporeal shock wave therapy (LIESWT) improves erectile function (EF) in men with vascular erectile dysfunction (ED) but longer-term outcomes remain unknown. AIM: To evaluate the clinical outcomes of LIESWT at a minimum 5-year follow-up. METHODS: This is an open-label single-arm prospective study involved men with vascular ED who received LIESWT. MAIN OUTCOME MEASURE: Changes in patient demographics, IIEF-5 and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, as well as overall satisfaction score (on a 5-point scale) were reviewed at 12, 24, 48, and 60 months after completion of LIESWT. A chi-square contingency analysis was used to examine the relationship between erectile function score and treatment satisfaction, with statistical significance set at 5%. RESULTS: The mean follow-up period was 69.9 (63-82; median 76) months. The mean IIEF-5 scores for pretreatment and after treatment at 12, 24, 48, and 60 months were 14.8, 17.6, 16.8, 16.5, and 16.5 while the percentages of patients who reported an improvement in IIEF-5 score by 5 points were 60%, 45%, 40%, and 40%; and EDITS scores >50% were recorded in 70%, 55%, 50%, and 48% of patients at 12, 24, 48, and 60 months post-LIESWT. Ten patients required medical therapy and 2 patients opted for penile prosthesis implantation. The overall satisfaction rate appeared sustained subsequent follow-up (score 4 out of 5; 68% vs 50% vs 40% vs 40% at 12, 24, 48, and 60 months). There were minor time-limited, but no significant adverse event reported. CONCLUSION: This long-term study showed the observed clinical improvement in EF continues to deteriorate but appears to plateau at 40% clinical efficacy at 48-60 months after completion of LIESWT. The absence of penile pain and deformity at 5-year follow-up supports the long-term safety data of LIESWT in men with ED. Chung E, Cartmill R. Evaluation of Long-Term Clinical Outcomes and Patient Satisfaction Rate Following Low Intensity Shock Wave Therapy in Men With Erectile Dysfunction: A Minimum 5-Year Follow-Up on a Prospective Open-Label Single-Arm Clinical Study. Sex Med 2021;9:100384.

Adjustable versus non-adjustable male sling for post-prostatectomy urinary incontinence: A prospective clinical trial comparing patient choice, clinical outcomes and satisfaction rate with a minimum follow up of 24 months.

AIMS: To review the patient choice, clinical outcomes and satisfaction rate between adjustable and non-adjustable male sling (MS) with a minimum follow up of 24 months. METHODS: A prospective review of clinical parameters in all male patients who underwent MS surgery between January 2009 and December 2011 was undertaken. Validated instruments were utilized in the follow-up survey. RESULTS: A total of 44 MS were inserted with 25 men choosing adjustable Argus (Promedon, Cordoba, Argentina) and 19 men received non-adjustable AdVance (American Medical Systems, Minnetonka, MN) MS. The mean age and follow-up for men in the Argus group were 65.4 years and 36.2 months, and in AdVance group were 63.8 years and 33.1 months. Revision surgery was performed in six Argus MS for recurrent urinary incontinence. Social continence (defined as 0 to 1 urinary pad use) was achieved in 23 patients (92%) with Argus MS and 16 patients (84%) with AdVance MS (P = 0.45). The overall satisfaction rate on a 5-point scale was 4.5 in Argus and 4.3 in AdVance patients, and there was no significant difference in the PGI-I score between the two groups (P = 0.36). Kaplan-Meier analysis of urinary continence and patient satisfaction rates were not statistically significant between Argus and AdVance slings (P = 0.76 and P = 0.38). CONCLUSIONS: Given the choice between the two types of MS, more men chose adjustable Argus over non-adjustable AdVance sling. There was no significant difference in the clinical outcome, social continence and overall patient satisfaction rates between the two types of MS in the short term. Neurourol. Urodynam. 35:482-486, 2016. © 2015 Wiley Periodicals, Inc.

Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial.

OBJECTIVE: To evaluate the efficacy, safety and patient satisfaction rate with low-intensity extracorporeal shockwave therapy (LiESWT) in Australian men with erectile dysfunction (ED), as LiESWT induces neovascularisation and potentially enhances penile perfusion and improves erectile function. PATIENTS AND METHODS: Open-label single-arm prospective study of patients with ED with five-item version of the International Index of Erectile Function (IIEF-5) scores of >12 at baseline were enrolled after informed consent. Patient demographics, change in IIEF-5 and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, and overall satisfaction score (on a 5-point scale) were recorded. Treatment consists of 3000 shockwaves (1000 shockwaves to the distal penis, base of penis and corporal bodies at the perineum) twice weekly for 6 weeks. RESULTS: All patients had tried and failed oral phosphodiesterase type 5 inhibitors and most of the patients hah had ED for >18 months [mean (range) 21.8 (6-60) months]. No side-effects to LiESWT were reported. Most patients reported an improvement in IIEF-5 score by 5 points (60%) and EDITS Index score by >50% (70%). Most patients were satisfied (scoring 4 out of 5; 67%) and would recommend the therapy to their friends (80%). CONCLUSION: LiESWT appears to improve erectile function, is safe and potential plays an important role in penile rehabilitation in men whom failed medical therapy.

Diagnostic challenges in the evaluation of persistent or recurrent urinary incontinence after artificial urinary sphincter (AUS) implantation in patients after prostatectomy.

There is a lack of information pertaining to the postoperative evaluation in patients with artificial urinary sphincter (AUS) implants who complain and continue to have urinary incontinence (UI). Two types of UI can occur after the activation of an AUS device these are: early or initial (persistent) UI, and delayed (recurrent) UI. There are many causes of persistent and/or recurrent UI and these can sometimes overlap. The potential causes include improper and/or accidental operation of the pump-control unit, overactive bladder, cuff atrophy, cuff erosion, improper cuff size and pressure-regulating balloon unit, as well as device malfunctions. The diagnostic evaluation in men with persistent and/or recurrent UI after AUS implantation requires sufficient understanding of the AUS mechanics and is a step-wise and logical process with careful history and thorough clinical evaluation. Once a diagnosis is made, patients should be counselled and appropriate treatment instituted.

Newer and novel artificial urinary sphincters (AUS): the development of alternatives to the current AUS device.

INTRODUCTION: The current artificial urinary sphincter (AUS), AMS 800 (American Medical Systems, Minnesota, MN, USA) is considered the standard of care for the treatment of urinary incontinence (UI). While the long-term effectiveness, safety, and durability of the current model of the AMS 800 are well documented, it is not without its limitations and complications. Over the last few years, improvements in design and innovative research into AUS devices have increased the treatment arsenal in male UI. METHODS: Articles from peer-reviewed journals, abstracts from scientific meetings and electronic literature searches formed the basis of this review. RESULTS: Newer AUS models, e.g. FlowSecure, Zephyr, Pro-ACT and other novel experimental AUS devices, are designed to simulate a healthy human sphincter and address the limitation of the existing AMS 800 device. CONCLUSIONS: Newer and novel AUS models are innovative and showed promising outcomes in short- to intermediate-term follow-up. However, there exists the need for prospective randomised clinical trials and complete reporting of adverse and long-term results before these AUS models can replace the existing AMS 800 device.

Can artificial urinary sphincter be an effective salvage option in women following failed anti-incontinence surgery?

INTRODUCTION AND HYPOTHESIS: The role of artificial urinary sphincter (AUS) as salvage option following failed anti-incontinence surgery is unclear. METHODS: Database review and telephone survey were conducted to review patient satisfaction, surgical outcomes, device failure and revision rates. RESULTS: A total of 29 female patients received AUS following failed anti-incontinence surgeries. Five (17%) AUS devices were explanted due to AUS erosion or infection. Thirteen AUS revisions were made and device malfunction accounted for 95% of the cases. Kaplan-Meier analysis showed more than 90% of AUS malfunction occurred less than 100 months from the time of implant. There was a significant decrease in pad use (3.6 to 0.2 pads per day; p < 0.01). The continence rate with no pad use was 70% and this increases to 83% in patients wearing one precautionary pad. CONCLUSION: AUS is a safe, durable and effective salvage option for females with previous failed anti-incontinent surgeries.

25-year experience in the outcome of artificial urinary sphincter in the treatment of female urinary incontinence.

OBJECTIVE: To report the outcome of artificial urinary sphincter (AUS) in female patients for the treatment of stress urinary incontinence (SUI). PATIENTS AND METHODS: We retrospectively reviewed all female patients with AUS implanted over the last 25 years in one institution. Patient demographics, renal tract imaging and urodynamics assessment were documented. Outcomes measures included complications, duration and cause of AUS failure. Urinary continence was defined as no pad use after AUS insertion. AUS failure was defined as malfunction, infection or erosion. AUS malfunction included either mechanical (fluid leak) or non-mechanical (infection or surgical damage to AUS). A Kaplan-Meier analysis was used to determine device failure over time. RESULTS: In all, 47 consecutive women with a mean (range) age of 51 (17-78) years received an AUS for the treatment of UI. Of these, 35 women had failed anti-incontinence surgery previously. There were two wound infections after AUS insertion but no mortality. Of the 47 AUS implanted, 39 (83%) AUS remained in situ. Eight (17%) AUS were removed due to AUS erosion or infection. There were 20 AUS revisions, 16 of which were primary AUS revisions. Most of the AUS revisions were related to mechanical malfunctions. Comparison of the proportion of AUS device survival over time using Kaplan-Meier analysis showed >80% of AUS remained functioning after 100 months. At the time of review, 83% of patients had a device in situ and the continence rate with no pads use was 59% with AUS only; this figure increased to 85% when concurrent clean intermittent self-catheterization was performed. CONCLUSIONS: AUS is an effective and durable treatment option for female SUI. In properly selected women, high continence rates can be achieved. Most patients maintained satisfactory long-term continence rates despite revision surgery.