Adjustable Transobturator Male System Research Articles

Treatment of male stress urinary incontinence with the adjustable transobturator male system: Outcomes of a multi-center Iberian study.

To evaluate effectiveness and safety of the adjustable transobturator male system (ATOMS) for male stress urinary incontinence (SUI). A retrospective multicenter study was conducted in nine Iberian institutions using a board-approved database for 215 patients intervened between 2012 and 2017, with no case excluded. Continence status, patient satisfaction, number, and grade of complications (Clavien-Dindo) and factors affecting dry rate at adjustment were evaluated. Multivariate analysis defined the population at best success rate. Incontinence recurrence due to device failure and/or explant was evaluated and Kaplan-Meier curve for durability performed. Adjustment was achieved at a mean 1.4 ± 1.9 fillings. Dry-rate after adjustment was 80.5% (96.2% mild and 75.3% moderate-severe), 121 (56.3%) used no pads, and 52 (24.2%) a security pad with urine loss under 10 mL. Mean basal daily pad-test and pad-count decreased from 484 ± 372.3 mL and 3.9 ± 2 pads to 63.5 ± 201.2 mL and 0.9 ± 1.5pads (both P < 0.0001). Satisfaction rate was 85.1% (94.3% mild and 82.1% moderate-severe). Factors associated to dryness were: lesser severity of SUI (P < .0001), absence of radiotherapy (P = 0.0002) and device generation (P = 0.05). Multivariate analysis revealed absence of radiation (OR = 3.12; 1.36-7.19), mild (OR = 19.61; 3.95-100), and moderate (OR = 2.48; 1.1-5.59) SUI were independent predictors. Complications presented in 33(15.35%); 66.7% grade 1, 9.1% grade 2, and 24.2% grade 3. At 24.3 ± 15 mo mean follow-up device was explanted in seven (3.25%) and SUI worsened after adjustment in nine (4.2%). Dry-rate at follow-up was 73% and durability of device in dry patients at adjustment was 89.8% (82.9-94) at 2-years. This study confirms ATOMS device is safe and achieves high treatment efficacy and patient satisfaction in a multicenter setting. Significantly better results are achieved in less severe and non-irradiated cases. Durability of the device is reassuring in the short-term.

The Adjustable Transobturator Male System in Stress Urinary Incontinence After Transurethral Resection of the Prostate

To investigate the efficacy and safety of the Adjustable Transobturator Male System (ATOMS) in men with stress urinary incontinence after transurethral resection of the prostate (TURP). From a large international prospectively administrated ATOMS register, we identified 49 patients with an ATOMS device as a result of persistent stress urinary incontinence after TURP. For evaluation, the men were divided into standard transurethral resection of the prostate (sTURP) and palliative transurethral resection of the prostate (pTURP) in radiated patients. Baseline and follow-up measurements included continence parameters, urodynamics, quality-of-life surveys (Patient Global Impression-Improvement and International Consultation on Incontinence Questionnaire-Short Form), and pain ratings. The dry rate (0-1 security pad/<10 mL urine loss), the success rate (overall improvement), removals, complications, and treatment failures were recorded. A P value of <.05 was considered statistically significant. After a median of 34 and 22 months' follow-up and 2-3 adjustments, the sTURP and pTURP cohorts had 58% and 50% dry rates and 90% and 87% success rates. Hence, no improvement was seen in 10% and 13%. The removal rate was higher in pTURP (50% vs 10%, P = .0171) and infection was the most common side effect (50%) observed. Neither intraoperative nor Clavien-Dindo 4 and 5 adverse events were recorded. In sTURP and pTURP, the median daily pad count and the pad test improved significantly (all P <.001), and quality-of-life parameters shifted to a high satisfaction level (P <.001 and P = .001). Urodynamics remained unchanged and postoperative pain was not an issue. The ATOMS device shows promising treatment outcomes in patients after TURP and a similar efficacy as in postprostatectomy incontinence. There is no difference in continence outcome between sTURP and pTURP; however, a higher removal rate was found after pTURP, which may be important for patient counseling.

Single-centre experience in using the adjustable transobturator male system in treatment of stress urinary incontinence in patients after radical prostatectomy

Context: Urinary incontinence is the most threatening complication after radical prostatectomy. This disorder has an important impact on the quality of life of patients and its treatment is a challenge for urologists as well. Objective: The objective of this article is to report our experience with the adjustable transobturator male system (ATOMS, AMI, Austria) for the treatment of post-prostatectomy incontinence. Material and methods: A total of 35 men with post-prostatectomy incontinence were treated. Before and after device implantation, the number of pads used per day was counted, and a one-hour pad test, uroflowmetry and postmicturition residual volume were assessed. Prior to surgery, anastomosis stricture was either ruled out or treated. To evaluate the success rate, ‘cured’ was defined as no pad use or one safety pad, ‘improved’ was defined as one or two pads or reduction of pad usage by more than 50%, respectively. All data about efficacy and safety were collected from all 35 patients. Results: After a median (range) follow-up of 21.2 (3–63) months, the success rate was 32 out of 35 patients (91.5%) with 22 patients (62.9%) ‘cured’ and 10 patients (28.6%) ‘improved’. Recovery of continence was achieved in seven patients (20.0%). The remaining patients (80%) needed an adjustment. The mean (range) number of adjustments to reach desired results (continence, improvement or patient satisfaction) was 4.3 (1–15). The most common adverse event was transient perineal pain, which was reported in 14 (40%) patients and disappeared within two weeks. Temporary urine retention appeared in one patient (2.9%). There were three cases (8.6%) of wound infection at the site of a port leading to explantation of the port in two patients (5.7%) and the removal of the system in one patient (2.9%). Conclusion: Treatment of post-prostatectomy incontinence with the self-anchoring ATOMS is safe and effective.

934 - Adjustable transobturator male system with pre-attached scrotal port for the treatment of male stress urinary incontinence

934 - Adjustable transobturator male system with pre-attached scrotal port for the treatment of male stress urinary incontinence

Experience after 12 cases with the adjustable transobturator male sling for postprostatectomy stress urinary incontinence.

The aim of the study was the prospective evaluation of the efficacy of the adjustable transobturator male system (ArgusT®) for the treatment of postprostatectomy stress urinary incontinence (PPI). Twelve consecutive patients were treated with ArgusT system for PPI. All patients were comprehensively evaluated preoperatively and after 3 and 6 months regarding daily pad use, residual urine, Incontinence Quality of Life Scale (I-QoL) score and International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score. Cure rate was defined as no pad use or one pad (used for security reasons). At 3 and 6 months, we achieved a cure rate of 91%. The mean number of pads per day decreased from 4 ± 1.3 to 0.7 ± 0.9 and 0.5 ± 0.9 after 3 and 6 months, respectively (p<0.001). Only one patient showed no significant improvement. Compared with baseline, the mean ICIQ-SF score dropped from 17.3 ± 2.8 to 2.7 ± 3.8 and 2.4 ± 3.8, at 3 and 6 months, respectively (p<0.001). The mean I-QoL score also improved significantly from 53.1 ± 20.3 to 99.5 ± 11 and 96.8 ± 12.5 after 3 and 6 months, respectively (p<0.001). Postoperative acute urinary retention was seen in one patient. In our early experience, the ArgusT system offers effective, safe and minimally invasive treatment option for PPI.

Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS® , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (<10 mL/day and 0-1 pad/day), device durability, treatment failure, and device complications were recorded. Nonparametric tests were used for statistical analyses. After a median (interquartile range [IQR]) follow-up of 31 (10-54) months and a median (IQR) of 3 (2-4) adjustments, the overall success rate was 90% (258 men) and the dry rate was 64% (184). Daily pad test and pad use decreased from a median of 400 mL/day and 4 pads/day to a median of 18 mL/day and 1 pad/day (both P < 0.001), concomitantly QoL ratings significantly improved and changed to a high level of satisfaction (PGI-I 4 to 2, ICIQ-SF 17 to 5; both P < 0.001). The UI results at 12 months were comparable to those at final follow-up. Chronic pain and intraoperative complications did not occur. Most of the postoperative complications were Clavien-Dindo grade I-III (no grade IV or V). At present, 231 (80%) of all the ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P < 0.001) were prognostic factors for beneficial treatment outcome. The ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy.

Five-year experience with the adjustable transobturator male system for the treatment of male stress urinary incontinence: a single-center evaluation.

We report on our 5-year experience with the adjustable transobturator male system (ATOMS®, A.M.I., Feldkirch, Austria). Between 10-2009 and 10-2014, 54 patients received an ATOMS. The mean follow-up of this retrospective observational trial was 27.5±18.4 (2.3-59)months. Within each follow-up, the following were evaluated: micturition protocol, 24-h pad count, uroflowmetry and residual volume. Statistical analysis was performed with SigmaPlot® 11.0, p<0.05 considered as significant. Stress urinary incontinence (SUI) I°, II° and III° was seen in 1 (1.9%), 16 (29.6%) and 37 patients (68.5%), respectively. In summary, 48.1% of the patients became "dry" (0-"safty pad"/day), while 29.6% achieved at least an "improvement" of about more than 50% (1-2 pads/day), which corresponds to an overall success rate of 77.7%. The mean number of pads/day decreased from 7.7 to 1.6. Regarding the initial degree of SUI, patients with mild or moderate incontinence had a significantly better outcome (p=0.002, 95% CI 0.9066 to 2.760). Postoperative complications were scaled according to the Clavien classification, in which we have seen 4 grade I-, 1 grade IIIa- and 9 grade IIIb-complications (overall 25.9%). The evaluation of quality of life by ICIQ-SF showed a significant improvement (p=0.0001, 95% CI -14.56 to -11.75). The treatment of male SUI using the ATOMS incontinence system achieved the best results in patients with mild and moderate incontinence. For severe incontinent patients, the system represents an efficient alternative.

345 Long-term efficacy and safety of the Adjustable Transobturator Male System (ATOMS): 6-year results of a European multi-institutional study

345 Long-term efficacy and safety of the Adjustable Transobturator Male System (ATOMS): 6-year results of a European multi-institutional study

Sexuality and erectile function after implantation of an Adjustable Transobturator Male System (ATOMS) for urinary stress incontinence. A multi-institutional prospective study.

To investigate erectile function and sexuality before/after implantation of the ATOMS device including continence outcome, pain perception and co-morbidities. We collected data from 34 patients (2010-2014) who were provided with an ATOMS implant due to mild or moderate stress urinary incontinence (SUI) after radical prostatectomy (RPE), transurethral resection (TURP) or radiotherapy. Previous failed implants were no contraindication. Sexuality was evaluated with the International Index of Erectile Function (IIEF-5). The Visual Analog Scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) were used to analyse pain perception. Results regarding continence, influence of co-morbidities and drug intake were interpreted. IIEF-5 score increased 6 months after ATOMS implantation with a mean difference of 2.18 (Cl: 1.22, 3.14), p &lt; 0,001). Non-sexually active patients had the greatest benefit. However, 50% of patients achieved a mean IIEF-5 of 10.1 and 38% of patients reported a new onset of sexual activity at follow up (mean IIEF-5 score of 12.9). This is in accordance with reduced SUI and absence of persistent pain syndrome. Overall success rate regarding 24h pad-use was 88% (no pad rate 38%). Previous failed implants did not influence results but diabetes, obesity and drug intake (beta-blockers, antidepressants) led to poorer outcomes. Sexuality and erectile function improves significantly 6 months after ATOMS implantation. We postulate that reduced SUI (also during sexual activity) and absence of chronic pain are the improving factors. ATOMS should be offered to men with mild to moderate SUI who are interested in regaining their erectile function and sexual activity.

Risk Factors for Treatment Failure With the Adjustable Transobturator Male System Incontinence Device: Who Will Succeed, Who Will Fail? Results of a Multicenter Study

To identify risk factors for treatment failure of men with the adjustable transobturator male system (ATOMS) for treating stress urinary incontinence (SUI). Sixty-two patients with SUI after prostate surgery were provided with an ATOMS. The self-defined criteria for treatment failure (implant removal [A], no improvement or ≥3 pads/24 hours [B], and no improvement or ≥150 mL urine loss/24 hours [C]) were compared to anamnestic, clinical, and time-specific parameters: age, Charlson comorbidity index (CCI), urine culture (UC), previous ineffective implants, body mass index, radiotherapy, renal function (serum creatinine), smoker status, urethral strictures, SUI severity, surgery time, time to and season at implantation, and port system application. After a median follow-up of 17.7 months, 9 ATOMS (15%) were removed due to infection (8) or dysfunction (1); 23% and 16% had treatment failure of criteria B and C. Dry rate/overall success rate was 61%/87%. Age alone was no risk factor but the CCI and a positive UC were univariate significant predictors of the criteria A, B, and C. Besides, previous devices and renal failure were significantly associated with implant removal (A) and SUI severity with criterion C. In multivariate analysis, previous devices (P = .0163), positive UC (P = .0190), and SUI severity (P = .0123) were the strongest predictors of A, B, and C, respectively. A poor CCI, preoperative positive UC, severe SUI, and previous implants lead to more treatment failure and removal. Age, body mass index, radiotherapy, urethral strictures, current smoking, time-specific parameters, seasonality, and port system application did not influence the outcome.

First experience with the ATOMS(®) implant, a new treatment option for male urinary incontinence.

IntroductionUrinary incontinence (UI) is defined as any complaint of involuntary urine leakage. A description is provided of our experience with the ATOMS® (Adjustable Transobturator Male System. Agency for Medical Innovations. A.M.I.) adjustable implant in patients with mild to moderate UI.Material and methodsA retrospective study was made of the data referring to 13 patients treated with this adjustable system. Demographic and personal data were collected along with information on the etiology, severity, characteristics, duration of UI, complementary tests, surgery times, complications and results obtained.ResultsThe full continence (no use of pad) recovery rate at the close of the study was 12/13 (92.3%). Three cases required a single filling during the mean 16 months of follow–up (range 4–32; median 14 months). A complication in the form of perineal hematoma was resolved with conservative treatment and a case of urinary retention was resolved by placing a bladder catheter for the duration of one week. Three patients experienced perineal–scrotal dysesthesias that disappeared spontaneously in the first three months.ConclusionsThe described adjustable continence system has been found to be very effective in males with mild to moderate UI. In our experience, the ATOMS® implant offers excellent results over the middle term with a very low rate of complications that were easily resolved in all cases.

Continence Care Literature Review 2012

Continence Care Literature Review 2012

1009 More than 3 years of clinical experience with an adjustable transobturator male system (ATOMS) for treatment of stress urinary incontinence after radical prostatectomy: Results of a multicenter prospective observational study

1009 More than 3 years of clinical experience with an adjustable transobturator male system (ATOMS) for treatment of stress urinary incontinence after radical prostatectomy: Results of a multicenter prospective observational study

Early results of a European multicentre experience with a new self‐anchoring adjustable transobturator system for treatment of stress urinary incontinence in men

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.

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

We report on our initial experience in terms of efficacy and safety with a new, self-anchoring adjustable transobturator male system (A.M.I.® ATOMS System) for the treatment of male stress urinary incontinence after prostate surgery. In this prospective, nonrandomized single center study conducted between March and December 2009, patients with stress urinary incontinence secondary to prostatic surgery were treated with the ATOMS device. Urethroscopy, filling and voiding cystometry were performed preoperatively for all patients. In addition, incontinence symptoms were assessed, and a physical examination, 24-hour pad test and 24-hour pad count were performed before and after surgery. A total of 38 patients were included in the study (36 after radical prostatectomy, 2 after benign prostatic hyperplasia surgery). No intraoperative complications occurred. Mean number of adjustments during followup was 3.97 (range 0 to 9). At a mean followup of 16.9 months (range 13 to 21) the overall success rate was 84.2%. Of the successful cases 60.5% were considered dry (0 to 1 pad and less than 15 ml/24-hour pad test) and 23.7% improved (more than 1 pad per 24 hours but more than 50% decrease in pad use and less than 100 ml per 24-hour pad test). In 15.8% of the patients the treatment was considered to have failed (more than 2 pads daily and greater than 100 ml on 24-hour pad test). The treatment of male stress urinary incontinence with the ATOMS is safe and effective. It is an excellent first or second line treatment for mild to moderate male stress urinary incontinence, even after external irradiation. The option of long-term, minimally invasive adjustment to respond to patient needs is a significant advantage of this new implant.

UP-03.180 The Self Anchoring Adjustable Transobturator Male System (ATOMS®) in the Treatment of Stress Urinary Incontinence in Men: A Retrospective Multicenter Study of 99 Patients

UP-03.180 The Self Anchoring Adjustable Transobturator Male System (ATOMS®) in the Treatment of Stress Urinary Incontinence in Men: A Retrospective Multicenter Study of 99 Patients

Artificial Urinary Sphincter Versus Male Sling for Post-Prostatectomy Incontinence—What Do Patients Choose?

Early outcomes of the male sling to correct post-prostatectomy incontinence have been promising in select patients. Long-term data are lacking to determine whether the male sling is as effective as the artificial urinary sphincter, which is the current gold standard. Because the male sling offers the significant advantage of avoiding a mechanical device but without established success, we determined the patient preference for the male sling vs the artificial urinary sphincter. We reviewed the charts of 133 men with post-prostatectomy incontinence who underwent the first procedure to correct incontinence. After urodynamics the surgeon recommended an artificial urinary sphincter or a male sling and patients were told the artificial urinary sphincter satisfaction rate and shorter term data on the male sling. Patients with high grade post-prostatectomy incontinence (pad weight greater than 400 gm/24 hours) were recommended to receive an artificial urinary sphincter, those with moderate post-prostatectomy incontinence (pad weight 100 to 400 gm/24 hours) were recommended to receive an artificial urinary sphincter or a male sling and those with mild post-prostatectomy incontinence (pad weight less than 100 gm/24 hours) were recommended to receive a male sling. A total of 84 male sling (63%) and 49 artificial urinary sphincter (37%) procedures were performed. The surgeon recommendation was an artificial urinary sphincter in 63 men (47%) and a male sling in 46 (35%). A total of 24 men (18%) were given the option of either procedure. All patients recommended to receive a male sling chose it. When an artificial urinary sphincter was recommended, 75% of patients chose it, while 25% chose a male sling. When given a choice, 92% of patients chose a male sling and 8% chose an artificial urinary sphincter. Most patients adhere to the surgeon recommendation. When men with post-prostatectomy incontinence are offered the choice of an artificial urinary sphincter vs a male sling, the opportunity to avoid using a mechanical device is preferable to undergoing a well established procedure. Men who strongly wish to avoid a mechanical device are willing to go against the surgeon recommendation for an artificial urinary sphincter.

Long-Term Durability and Functional Outcomes Among Patients With Artificial Urinary Sphincters: A 10-Year Retrospective Review From the University of Michigan

The artificial urinary sphincter continues to be one of the most effective and commonly used surgical treatments for severe urinary incontinence. The long-term durability and functional outcome remains unclear. This study sought to report the artificial urinary sphincter complication rates, associated risk factors with complications, and long-term quality of life and durability. This single institution study reports the outcomes of 124 consecutive index cases of artificial urinary sphincter from 1996 to 2006 for complications (infection, erosion, and mechanical failure). Bivariate statistics and multivariable logistic models were used to identify patient and artificial urinary sphincter characteristics associated with complications. Functional outcomes and long-term durability were assessed using a cross sectional analysis of a validated health related quality of life survey and a product limit estimates, respectively. Among the 124 male patients median followup was 6.8 years. The overall complication rate for patients undergoing an artificial urinary sphincter was 37.0%, with mechanical failure the most common cause (29), followed by erosion (10) and then infection (7). Significant differences between complications and specific patient and artificial urinary sphincter characteristics risk factors were not found. Functional outcomes appeared stable with similar mild-moderate urinary incontinence severity and 0 to 1 daily pad use at intervals of 0 to 4 years, 4 to 8 years and more than 8 years. Long-term durability was notable with 36% having complications (requiring surgical revision or removal) within 10 years and most events occurring within the first 48 months. Long-term durability and functional outcomes are achievable for the AMS 800, but there are appreciable complication rates for erosion, mechanical failure and infection in the first 48 months from implantation.