A Novel Artificial Urinary Sphincter (VICTO®) for the Management of Postprostatectomy Urinary Incontinence: Description of the Surgical Technique and Preliminary Results from a Multicenter Series

2021 ◽  
pp. 1-7
Author(s):  
Alessandro Giammò ◽  
Marco Falcone ◽  
Gideon Blecher ◽  
Enrico Ammirati ◽  
Paolo Geretto ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Short Form ◽  
Nonparametric Tests ◽  
Artificial Urinary Sphincter ◽  
Pad Test ◽  
International Consultation ◽  
Urinary Sphincter ◽  
Male Patients ◽  
Continence Rate

Aims: The objective of the study was to analyze short-term outcomes and safety profile of the newly designed artificial urinary sphincters (AUSs) VICTO® and VICTOplus®. Methods: Data from the implant of VICTO® or VICTOplus® AUSs on a series of consecutive male patients with stress urinary incontinence (SUI) following radical prostatectomy (RP) were retrospectively collected in 3 tertiary referral centers between May 2017 and December 2019. Patients were affected by moderate-severe genuine SUI (200–400 or >400 g urine leakage in 24-h pad test) refractory to conservative treatment. Outcomes were evaluated through the 24-h pad test and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). Follow-up was scheduled after 3, 6, and 12 months and then when clinically needed. Nonparametric tests were applied in subgroup analyses. Results: Seventeen patients were enrolled: 8 were implanted with the VICTO® device and 9 with VICTOplus®. The median age at surgery was 69 (interquartile range (IQR) 60–75) years. The median follow-up was 15 (IQR 12–18) months. At 12 months, the dry rate was 76.4% and the social continence rate was 94%. The postoperative complication rate was 17.6%. All complications were classified as Clavien-Dindo I. No difference in terms of outcomes was observed between the VICTO® and the VICTOplus® subgroups. Conclusions: Preliminary outcomes of the VICTO® and VICTOplus® implantation are satisfactory. These devices may represent a safe and realistic solution for patients with moderate-severe SUI following RP.

scholarly journals Urinary Artificial Sphincter ZSI 375 for Treatment of Stress Urinary Incontinence in Men: 5 and 7 Years Follow-Up Report

2017 ◽  
Vol 84 (4) ◽  
pp. 263-266 ◽  
Author(s):  
Christophe Llorens ◽  
Tobias Pottek
Keyword(s):  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Artificial Urinary Sphincter ◽  
Minimal Period ◽  
Artificial Sphincter ◽  
Urethral Erosion ◽  
Randomised Study ◽  
Urinary Sphincter ◽  
Male Patients

Study Design This is a retrospective, non-randomised study. Objectives The aim of this study was to evaluate safety and efficacy of artificial urinary sphincter ZSI 375 inserted in male patients with stress urinary incontinence (SUI). Methods Between May 2009 and January 2017, 45 men with SUI underwent ZSI 375 device insertion. Operations were performed in two French centres by one surgeon. Complications and pad used to manage continence were recorded. Results From May 2009 to January 2012, 45 patients with a mean age of 70.42 years underwent placement of the ZSI 375 device in France. The most common cause for incontinence was radical prostatectomy (RP, 33/45 ­patients, 73.33%). The minimal period of incontinence was 6 months. Twenty-seven out of 45 patients (60.00%) had a severe incontinence (at least four pads per day), 13 patients (28.89%) had moderate incontinence (three pads per day) and five patients (11.11%) had two pads per day. With a long follow-up, the ZSI 375 device was considered to be successful in 73.33% patients after 5 years (60 months) and 72% of patients after 7 years (84 months). The infection rate was 2.2 % affecting one in 45 patients. Six out of 45 patients presented a urethral erosion (13.33%). Mechanical failure with a revision occurred in three patients (6.67%). Conclusions The ZSI 375 device is a safe and effective device to treat severe SUI in men.

scholarly journals Multicentre Experience with ZSI 375 Artificial Urinary Sphincter for the Treatment of Stress Urinary Incontinence in Men

2017 ◽  
Vol 84 (3) ◽  
pp. 148-152 ◽  
Author(s):  
Ireneusz Ostrowski ◽  
Mariusz Blewniewski ◽  
Frank Neugart ◽  
Burkhard von Heyden ◽  
Oscar Selvaggio ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Artificial Urinary Sphincter ◽  
Secondary Outcome ◽  
Urethral Erosion ◽  
Safety And Efficacy ◽  
Urinary Sphincter ◽  
Male Patients ◽  
Complications Rate

Objectives 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. Methods 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. Results 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. Conclusions This study confirmed safety and efficacy of ZSI 375 device to treat moderate-to-severe SUI in men.

scholarly journals Real-world effectiveness of app-based treatment for urinary incontinence: a cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040819
Author(s):  
Pontus Rygh ◽  
Ina Asklund ◽  
Eva Samuelsson
Keyword(s):  
Urinary Incontinence ◽  
Cohort Study ◽  
Real World ◽  
Short Form ◽  
Pelvic Floor Muscle ◽  
Controlled Trial ◽  
Healthcare Services ◽  
International Consultation ◽  
The Mean

ObjectivesThe efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.DesignProspective cohort study.ParticipantsDuring a 17-month period, 24 602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.InterventionThree months’ use of the app Tät, containing information, a pelvic floor muscle training programme and lifestyle advice.Main outcome measuresChange in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).ResultsOf the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.ConclusionsThe app Tät was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.

scholarly journals Five-year Follow-up of Transobturator Sling: 152 Cases with the Same Surgeon

2018 ◽  
Vol 40 (10) ◽  
pp. 614-619
Author(s):  
Mucio Diniz ◽  
Luisa Diniz ◽  
Gustavo Lopes da Silva ◽  
Agnaldo Filho ◽  
Zilma Reis ◽  
...  
Keyword(s):  
Risk Factors ◽  
Urinary Incontinence ◽  
Short Form ◽  
Transobturator Sling ◽  
Logistic Regression Models ◽  
International Consultation ◽  
Surgical Failure ◽  
The Impact

Objective To evaluate the long-term subjective cure rate of the transobturator sling, including an analysis of the risk factors and of the impact of increased surgical experience on the results. Methods A retrospective cohort study of women who underwent transobturator sling surgery from 2005 to 2011 was conducted. Patients were evaluated by a telephone survey using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and by subjective questions regarding satisfaction. An ICIQ-SF score of 0 was considered a cure. The crude and adjusted odds ratios and 95% confidence intervals were estimated in univariate and multivariate logistic regression models to identify risk factors for surgical failure. Differences with p < 0.05 were considered significant. Results In total, 152 (70.6%) patients answered the questionnaire. The median follow-up period was 87 months. The urodynamic diagnosis was stress urinary incontinence in 144 patients (94.7%), and mixed urinary incontinence in 8 (5.3%) patients. Complications occurred in 25 (16%) patients. The ICQ-SF results indicated that 99 (65.10%) patients could be considered cured (ICIQ-SF score = 0). Regarding the degree of satisfaction, 101 (66%) considered themselves cured, 43 (28%) considered themselves improved, 7 (4.6%) considered themselves unchanged, and one reported worsening of the incontinence. After the univariate and multivariate analyses, the primary risk factor for surgical failure was the presence of urgency (p < 0.001). Conclusion The transobturator sling is effective, with a low rate of complications and a high long-term satisfaction rate. The risk factors for failure were the presence of urgency and patient age. The increased experience of the surgeon was not a factor that influenced the rate of complications.

scholarly journals A model identifying characteristics predictive of successful pelvic floor muscle training outcomes among women with stress urinary incontinence

2020 ◽  
Author(s):  
Kaylee C. L. Brooks ◽  
Kevin Varette ◽  
Marie-Andrée Harvey ◽  
Magali Robert ◽  
Robert J. Brison ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Stress Urinary Incontinence ◽  
Pelvic Floor ◽  
Pelvic Floor Muscle Training ◽  
Short Form ◽  
Pelvic Floor Muscle ◽  
Standing Position ◽  
Muscle Training ◽  
Pad Test ◽  
International Consultation

Abstract Introduction and hypothesis The aim of this study was to prospectively identify aspects of baseline demographic, clinical, and pelvic morphology of women with stress urinary incontinence (SUI) that are predictive of cure with physiotherapist-supervised pelvic floor muscle training (PFMT). Methods Women ≥18 years old with SUI were recruited from urogynecology and pelvic health physiotherapy clinics. Participants completed a 3-day bladder diary, the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), a standardized pad test, manual assessment of pelvic floor muscle (PFM) strength and tone, and transperineal ultrasound (TPUS) assessment of their urogenital structures at rest while in a supine position and standing, and during contraction, straining, and coughing. Participants attended six physiotherapy sessions over 12 weeks and performed a home PFMT program. The assessment was repeated after the intervention; cure was defined as a dry (≤2 g) pad test. Results Seventy-seven women aged 50 (±10) years completed the protocol; 38 (49%) were deemed cured. Based on univariate testing, four predictors were entered into a binary logistic regression model: ICIQ-UI-SF, PFM tone, bladder neck (BN) height in a quiet standing position, and BN height during a cough in a standing position. The model was significant (p < 0.001), accurately classifying outcome in 74% of participants. The model, validated through bootstrapping, performed moderately, with the area under the receiver operating characteristic curve = 0.80 (95% CI: 0.69–0.90; p = 0.00), and with 70% sensitivity and 75% specificity. Conclusions Women with better bladder support in a standing position and less severe symptoms were most likely to be cured with PFMT. Clinical trial registration #NCT01602107.

scholarly journals Treatment of Male Urinary Incontinence with An Adjustable Implantable Medical Device: Ustrap

2016 ◽  
Vol 9 (1) ◽  
pp. 35-43
Author(s):  
Pierre Dubernard ◽  
Elie Pricaz
Keyword(s):  
Clinical Trial ◽  
Urinary Incontinence ◽  
Medical Device ◽  
Artificial Urinary Sphincter ◽  
Prospective Clinical Trial ◽  
Implantable Medical Device ◽  
Urinary Sphincter ◽  
Male Urinary Incontinence

Introduction and Objectives: Our aim is to develop a device which is simpler, less expensive, but equally or more effective than currently available devices including the artificial urinary sphincter. Method: Based on our knowledge of and experience with other devices we designed the Ustrap. The theoretical advantages of our approach are described as is the development to the current (3rd) version. Results: For version #1, implanted in 6 patients, the 5 year follow up includes 2 improved, 2 unchanged, 2 required AUS. For version #2 implanted in 4 patients, 2 year follow up shows 3 improved, 1 failure. Conclusions: The Ustrap has unique features which distinguish it from current devices. A proposed multicenter prospective clinical trial of version #3 is awaiting approval.

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