Comparative Urodynamic Study in Cadaver of Urethral Pressure Profilometry Between the Artificial Urinary Sphincter UroActive and the AMS800.

To report our experience with a new self-anchoring adjustable transobturator male system (ATOMS®; AMI, Vienna, Austria) for the treatment of stress urinary incontinence (SUI) in men. A total of 99 men, in a number of centres, were treated for SUI with the new ATOMS® device. The device was implanted in all patients using an outside-in technique by passing the obturator foramen and anchoring the device to the inferior pubic ramus. The titanium port was placed s.c. on the left symphysis region. Adjustments were performed via port access. Postoperative evaluation consisted of physical examination, 24-h pad test, and 24 h-pad count. Preoperatively and at 6-month follow-up, patients completed a validated quality-of-life questionnaire. Two-way ANOVA was used to analyse changes over time. Within-group effects for time were tested using post hoc Dunnett's contrasts of baseline values vs subsequent measurements. The most common indication was SUI after radical prostatectomy (92.9%). Failure of previous surgeries was present in 34.3% patients and 31.3% patients had undergone secondary radiation. The mean (SD; range) surgery time was 47 (13.8; 29-112) min. Temporary urinary retention occurred in two patients (2%) and transient perineal/scrotal dysaesthesia or pain was reported by 68 patients (68.7%) and resolved after 3-4 weeks of non-opioid analgesics. There were four (4%) cases of wound infection at the site of the titanium port leading to explantation. No urethral or bladder injuries related to the device or erosions occurred. The mean (SD; range) number of adjustments to reach the desired result (dryness, improvement and/or patient satisfaction) was 3.8 (1.3; 1-6). After a mean (SD; range) follow-up time of 17.8 (1.6; 12-33) months, the overall success rate was 92% and the mean pad use decreased from 7.1 to 1.3 pads/24 h (P < 0.001). Overall, 63% were considered dry and 29% were improved. Treatment of male SUI with this self-anchored adjustable system is safe and effective.

Aim: The aim of this study was to assess the impact of pelvic floor muscle training (PMFT) in the treatment of stress urinary incontinence (SUI) in men after they received radical prostatectomy (RP). Methods: From November 2018 to September 2019, patients who underwent radical prostatectomy were assessed for eligibility. A total of 37 men were then randomly assigned to the experimental group (EG) and the control group (CG). The EG group received supervised exercise twice a week for 12 weeks, and the CG did not receive any intervention. To objectify the results obtained in both groups before and after the intervention, the authors assessed myostatin concentration. Moreover, the Expanded Prostate Cancer Index Composite (EPIC-26) was applied to assess the quality of life, and Beck’s Depression Inventory (BDI-II) was used to measure depression severity. Results: Study results demonstrated a statistically significant reduction of myostatin concentration in the EG following the treatment and no statistically significant differences in this parameter in the CG. In addition, a comparison of the EPIC-26 scores in the EG at the initial and final assessments revealed a statistically significant improvement in the quality of life in each domain. A comparison of the EPIC-26 scores in the CG at the initial and final assessments showed there is a statistically significant decline in quality of life in the “overall urinary problem” and “sexual” domain. A comparison of the BDI-II scores at the initial and final assessments showed a statistically significant decline in depressive symptoms in the EG and no statistically significant differences in the CG. Conclusions: PFMT is an effective treatment for urinary incontinence (UI) in men who received radical prostatectomy.

Initial Experience and Results With a New Adjustable Transobturator Male System for the Treatment of Stress Urinary Incontinence

Male stress urinary incontinence is predominantly iatrogenic, whereby radical prostatectomy is the most frequent cause. The first-line treatment of postoperative stress urinary incontinence is physiotherapy, in which training of pelvic floor muscles and sphincter play a major role. If conservative treatment fails surgical treatment is recommended. Nowadays, various options are available for the surgical treatment of stress urinary incontinence in men. Therefore, every patient with persistent postoperative urinary incontinence with psychological strain and desire for treatment should be offered surgical treatment. The selection of the surgical method should primarily be made depending on the contraindications.

Complications of Mid Urethral Slings: Important Outcomes for Future Clinical Trials

THE MALE SLING FOR STRESS URINARY INCONTINENCE: 24-MONTH FOLLOWUP WITH QUESTIONNAIRE BASED ASSESSMENT

Introduction. The main cause of stress urinary incontinence in men is prostate surgery - radical prostatectomy, transurethral resection of the prostate (TURP), enucleation, etc. The gold standard for the surgical treatment of urinary incontinence after prostate surgery is the implantation of an artificial urinary sphincter. For the treatment of mild/moderate urinary incontinence, implantation of synthetic urethral male slings is recommended. For the treatment of severe urinary incontinence, implantation of artificial urinary sphincter recommended. According to the Decree of the Moscow Government dated 12.24.2019 N 1822-PP, surgical interventions on the organs of the genitourinary system with the implantation of synthetic complex and mesh prostheses are included in the standards for the provision of high-tech medical care. Materials and methods. The paper presents a surgical technique for implantation of an artificial urinary sphincter model AMS 800 (Boston Scientific, Boston, MA, USA) and a male urethral sling AdVance XP (Boston Scientific, Boston, MA, USA). The indications for surgical treatment of stress urinary incontinence in men are listed, the criteria for selecting patients for the implantation of an artificial bladder sphincter and the installation of a urethral sling are described, and described in detail. Conclusion. The materials presented in the lecture will help urologists in mastering the technique of implantation of an artificial bladder sphincter and urethral sling in men.

The aim of this study was to evaluate the safety and efficacy of the artificial urinary sphincter ZSI 375 device in male patients with stress urinary incontinence (SUI) at 10 centres. This was a retrospective, nonrandomised, multicentre study. From January 2012 to December 2014, and follow-up to February 2016, men with SUI were treated with the ZSI 375 device. The primary outcome was continence. The secondary outcome was complications rate. A total of 147 patients with moderate-to-severe stress incontinence and mean age of 70.67 (26-85) years underwent implantation of the ZSI 375 device at 10 centres.The most common indication for placement was incontinence after radical prostatectomy (121 patients: 82.31%). The ZSI 375 device was considered successful in 86.40% of cases after 12 months follow-up, 83.52% after 24 months follow-up and 78.26% after 36 months follow-up. The infection rate was 6.12%, urethral erosion was 12.92% and mechanical failure was limited to 3.40% leading to ZSI 375 improvement. This study confirmed safety and efficacy of ZSI 375 device to treat moderate-to-severe SUI in men.

The Artificial Urinary Sphincter in the Management of Incontinence

To evaluate the urodynamic changes after placing a novel 'ventral urethral elevation plus' (VUE+) sling (Levera, Caldera Medical, Agoura Hills, CA, USA) in a cadaveric study, and in our initial experience in two patients. In two male cadavers (A and B) the maximum urethral closure pressure (MUCP) and retrograde leak-point pressure (RLPP) were measured before and after transperineal placement of the Levera sling. A 5.5 x 7 cm sling, with two 1.5 x 22.5 cm inferior extensions and two 1.5 x 25 cm superior extensions, was placed over the bulbar urethra. The inferior extensions were passed using the transobturator approach, and the superior extensions by a prepubic approach. This procedure was offered to two men (C and D) with severe neurogenic intrinsic sphincter deficiency. The mean baseline MUCP in specimen A was 55 cmH2O and the RLPP 35 cmH2O; after placing the sling the respective values increased to 75 and 70 cmH2O. In specimen B the respective mean values were 56 and 50 cmH2O, and after placing the sling were 82 and 75 cmH2O. In patient C, the RLPP increased from 17 cmH2O before surgery to 65 cmH2O afterward, and in patient D, from 20 to 70 cmH2O. At the 12-month follow-up, there was complete resolution of urinary incontinence in both patients. The VUE+ Levera sling provides urethral compression against the perineal membrane using a straightforward pre-pubic approach, and ventral elevation and compression of the bulbous urethra using the transobturator approach, avoiding the risks associated with of bone screws and retropubic needle passage. In our initial two patients stress incontinence was cured at 1 year of follow-up. A long- term follow-up and a larger prospective study of the VUE+ sling is needed to objectively assess the efficacy of this novel procedure.

IntroductionThe ZSI 375 is a new artificial urinary sphincter utilised in men suffering from stress urinary incontinence (SUI). We present the first European multicentre study on the effectiveness of ZSI 375.Material and methodsThis study was conducted in a retrospective, non-randomized format in centres across Europe. Between May 2009 and December 2014, ZSI 375 was fitted in 109 SUI patients following radical prostatectomy, transurethral resection of prostate (TURP), rectal surgery and high intensity focused ultrasound (HIFU). Patients with history of pelvic radiotherapy or previous surgical treatment for incontinence or stricture were excluded from the series. Follow-up was completed by December 2016. The key outcome measures included overall improvement and complication rates.ResultsA total of 109 patients in 10 European centres were recruited and had the ZSI 375 device implanted. The average patient age was 72 years old. The indication for the majority of patients was incontinence following radical prostatectomy (100/109 patients, 91.74%). On average, patients were incontinent for 48.6 months prior to treatment. All patients used ≥4 pads daily at baseline and thus were classified as suffering from ‘severe incontinence’. The average follow-up until the final visit was 43 months. The pad usage decreased to 0.84 on average by the last visit. There were no reported cases of device infection. A total of 9 patients had urethral cuff erosion (8.25%),which was the most common complication in this series. A further 3 men (2.75%) experienced mechanical failure requiring subsequent device reimplantation. The implantation of the ZSI 375 device was considered successful in 92.66% of patients.ConclusionsThe ZSI 375 is an effective surgical treatment option in men with severe stress urinary incontinence.

Dear Editor, The article by Barry et al. [1] is a nicely conducted multicenter randomized study from Australia, which further establishes the efficacy of transobturator approach (TO) of tension-free midurethral slings in the management of stress urinary incontinence (SUI), comparable to suprapubic tension-free vaginal tape (TVT-SP) at least in short term (objective and subjective success rates; 82.8 vs 78%, p= 0.51, and 84.2 vs 85.4%, p=0.66, respectively). It also establishes the safety advantage of this approach over the suprapubic counterpart with regards to bladder perforation (0 vs 8.5%, p<0.05), blood loss (49 vs 64 ml, p<0.05), and operative time (14.6 vs 18.5 min, p<0.001). However, while one can be assured of utilizing this approach with impunity in most of the cases of SUI, there are certain important issues to be addressed in a given individual case before embarking onto any approach for a successful outcome. Since the successful inception of pubovaginal sling more than a century ago, a lot of research has been undertaken towards improving the understanding of continence mechanisms in women. The focus has shifted from the bladder neck to the midurethra; DeLancey’s hammock hypothesis emphasized the importance of pubourethral ligaments in maintaining the continence, and lately Petros and Ulmstein proposed the “midurethra theory” elucidating the role of weakening of pubococcygeus muscle in addition of the former [2]. These theories have led to the development of TVTs placed at midurethral level by suprapubic, transobturator, or prepubic routes. The former has been proven to be highly efficacious over long term (85–92% success rate), which is equivalent to pubovaginal sling and superior to colposuspension, both in primary as well as in recurrent SUI [3]. Various single-armed clinical studies and randomized controlled trials have proven the efficacy, although short term, of transobturator tape procedure as well, with the added advantage of lower incidence of side effects, e.g., bladder perforation, postoperative voiding dysfunction, and early return to work. Despite the shift of the focus from bladder neck to midurethra, intrinsic sphincter deficiency (ISD) remains one of the important pathophysiological mechanisms underlying SUI, and some degree of ISD is present in most of the patients. Significant ISD is found in only a small percentage of patients and is usually associated with highgrade incontinence. There is still no consensus on the urodynamic definition of ISD and measures like maximal urethral closure pressure (MUCP) less than 20–30 cmH2O and Valsalva leak point pressure (VLPP) <60 cmH2O have been used for definition. There is only moderate correlation between the two parameters, and they are described to represent weakness at different levels: MUCP at midurethra and VLPP at bladder neck. Studies on TVT-SP have failed to demonstrate a significant effect of either of the parameters on the surgical results; however, a combination of both, along with absence of a significant hypermobility, has shown to be predictive of poor results [4]. Int Urogynecol J (2008) 19:893–894 DOI 10.1007/s00192-007-0485-7

The artificial urinary sphincter is the reference treatment for stress urinary incontinence in men, but it remains rarely used in women. This study aimed to compare long-term device survival between women and men, after the first implantation of an AMS800™artificial urinary sphincter (Boston Scientific) for the treatment of a non-neurogenic stress urinary incontinence. This retrospective cohort study included all patients with nonneurogenic stress urinary incontinence who underwent surgery in a large-volume university hospital between 2000 and 2013. The primary outcome was the overall survival of the device, defined as the absence of any repeated surgery (revision or explantation) during follow-up. Men and women were matched 3:1 according to age and year of implantation. Differences were analyzed using a Cox model accounting for matching and applying time intervals because hazards were not proportional over time. Sensitivity analyzes were performed, excluding firstly apopulation with a history of radiotherapy and secondly a population with more than one previous surgery for urinary incontinence. A total of 107 women were matched to 316 men. Median follow-up was 6.0 years (Q1-Q3 1.8-9.4): 7.0 years (Q1-Q3 3.1-10.3) for women and 5.1 years (Q1-Q3 1.3-9.1) for men. During the follow-up, 56 patients had an explantation of the device: 44 men (13.9%) and 12 women (11.2%), and 113 had a revision: 85 men (26.9%) and 28 women (26.1%). Men have a significantly higher risk of explantation or revision than women between 6 months and 8 years after implantation (hazard ratio 2.12 [1.29-3.48]). Before 6 months and after 8 years, there were no significant differences. Both sensitivity analyses found consistent results. This study suggests that device survival seems better in women after the first 6 months.

Introduction The artificial urinary sphincter (AUS) remains a “gold standard” in the treatment of male stress urinary incontinence (SUI). Despite being a standard of care for over 50 years, there is sparse data regarding the connection between SUI and sexual quality of life (QoL). Objective To examine the relationship between SUI and sexual QOL in men treated with the AUS. Analysis of the sexual health-related Incontinence Quality of Life (IQoL) item 22 in patients before and after AUS implant provides insight to understanding of this relationship. Methods The Artificial Urinary Sphincter Clinical Outcomes Trial (AUSCO) is a single-arm, prospective, multi-center study designed to evaluate objective and subjective outcomes of men with SUI treated with the AMS 800. This was approved by each institutional committee on ethics in human investigation (NCT04088331). A total of 115 patients served as their own controls and follow-up assessments at 12-months post device activation were compared to baseline values. The change in response to IQoL item 22, “I worry about having sex because of my urinary problems or incontinence,” was analyzed between baseline and 12 months. Patients who had ED recorded in their baseline medical history were also analyzed separately. Results Of the 115 implanted patients, 98 patients completed IQoL assessments at 12 months as of May 2024. Overall, there was a statistically significant improvement in responses to level of worry about having sex due to urinary problems (p &amp;lt; 0.001, Table 1). Improvement was observed in men with (p = 0.031) and without ED (p &amp;lt; 0.001). Specifically, 43.3% (39/90) of men without ED reported feeling “extremely” worried about having sex at baseline, which fell to 12.2% (11/90) at 12 months. Conversely, their responses of “not at all” worried about having sex increased from 18.9% (17/90) at baseline to 40.0% (36/90) at 12 months. Men with ED who reported being “extremely” worried about having sex decreased from 50% (4/8) at baseline to 25% (2/8) at 12 months. The number of responses of “not at all” worried about having sex increased from 0% at baseline to 12.5% (1/8) at 12 months. Lower pad weight and decreased pad use post-AUS were associated with improvement in this sexual quality of life measure. Improvement in sexual QOL was independent of age, BMI, and diabetes. Conclusions Men with and without ED showed an improvement in sexual quality of life at 12 months post AUS. The treatment of SUI in men with the AUS improves their level of worry as it relates to sexual activity. Disclosure Yes, this is sponsored by industry/sponsor: Boston Scientific Corporation. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific Corporation.

Transrectal Ultrasound Guided Implantation of the ProACT Adjustable Continence Therapy System in Patients With Post-Radical Prostatectomy Stress Urinary Incontinence: A Pilot Study