Dataset Information

Outcomes of a Series of Patients with Post-Prostatectomy Incontinence Treated with an Adjustable Transobturator Male System or Artificial Urinary Sphincter.

ABSTRACT:

Introduction

A prospective evaluation of outcomes in a series of patients with post-prostatectomy incontinence (PPI) treated with two different devices is presented.

Methods

Consecutive patients with PPI underwent interventions with an adjustable transobturator male system (ATOMS) or artificial urinary sphincter (AUS). Decisions were based on patient preference after physician counselling. Patient characteristics and operative and postoperative parameters including dryness, satisfaction, complications, revision and device durability were evaluated.

Results

One hundred twenty-nine patients were included: 102 (79.1%) received ATOMS and 27 (20.9%) AUS. Mean follow-up was 34.9?±?15.9 months. No difference was observed between patient age (p?=?0.56), ASA score (p?=?0.13), Charlson index (p?=?0.57) and radiation (p?=?0.3). BMI was higher for AUS (27.1 vs. 29.7; p?=?0.003) and also baseline incontinence severity (7.9% mild, 44.1% moderate and 48% severe for ATOMS vs. 11.1% moderate and 88.9% severe for AUS; p?=?0.0007). Differential pad test was higher for AUS (- 470 vs. - 1000 ml; p?ConclusionsBoth ATOMS and AUS are effective devices. Pad test change for AUS exceeds that of ATOMS. The revision rate is higher for AUS, and durability is superior for ATOMS. The satisfaction rate is equivalent. Larger series and longer follow-up are needed to compare both devices more appropriately. According to our experience, the AUS is not the only gold standard for PPI.

SUBMITTER: Esquinas C

PROVIDER: S-EPMC7854436 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Outcomes of a Series of Patients with Post-Prostatectomy Incontinence Treated with an Adjustable Transobturator Male System or Artificial Urinary Sphincter.

Esquinas Cristina C Ruiz Sonia S de Sancha Elena E Vazquez Mónica M Dorado Juan F JF Virseda Miguel M Arance Ignacio I Angulo Javier C JC

Advances in therapy 20201123 1

<h4>Introduction</h4>A prospective evaluation of outcomes in a series of patients with post-prostatectomy incontinence (PPI) treated with two different devices is presented.<h4>Methods</h4>Consecutive patients with PPI underwent interventions with an adjustable transobturator male system (ATOMS) or artificial urinary sphincter (AUS). Decisions were based on patient preference after physician counselling. Patient characteristics and operative and postoperative parameters including dryness, satisf ...[more]

PMID: 33230712

Similar Datasets

Project description:Background and purposeUrinary incontinence is one of the most serious complications of prostate cancer treatment. The objective of this study was to assess efficacy and safety of Adjustable Transobturator Male System (ATOMS) compared to Adjustable Continence Therapy (proACT) for male stress urinary incotinence according to literature findings.Material and methodsA systematic review and meta-analysis on adjustable devices ATOMS and ProACT is presented. Studies on female or neurogenic incontinence were excluded. Differences between ATOMS and proACT in primary objective: dryness status (no-pad or one safety pad/day) after initial device adjustment, and in secondary objectives: improvement, satisfaction, complications and device durability, were estimated using random-effect model. Statistical heterogeneity among studies included in the meta-analysis was assessed using tau2, Higgins´s I2 statistics and Cochran´s Q test.ResultsCombined data of 41 observational studies with 3059 patients showed higher dryness (68 vs. 55%; p = .01) and improvement (91 vs. 80%; p = .007) rate for ATOMS than ProACT. Mean pad-count (-4 vs. -2.5 pads/day; p = .005) and pad-test decrease (-425.7 vs. -211.4 cc; p < .0001) were also significantly lower. Satisfaction was higher for ATOMS (87 vs. 56%; p = .002) and explant rate was higher for proACT (5 vs. 24%; p < .0001). Complication rate for ProACT was also higher, but not statistically significant (17 vs. 26%; p = .07). Mean follow-up was 25.7 months, lower for ATOMS than ProACT (20.8 vs. 30.6 months; p = .02). The rate of working devices favoured ATOMS at 1-year (92 vs. 76; p < .0001), 2-years (85 vs. 61%; p = .0008) and 3-years (81 vs. 58%; p = .0001). Significant heterogeneity was evidenced, due to variable incontinence severity baseline, difficulties for a common reporting of complications, different number of adjustments and time of follow-up and absence of randomized studies.ConclusionsDespite the limitations that studies available are exclusively descriptive and the follow-up is limited, literature findings confirm ATOMS is more efficacious, with higher patient satisfaction and better durability than ProACT to treat male stress incontinence.

Project description:INTRODUCTION:Adjustable transobturator male system (ATOMS) is a surgical device developed to treat male stress urinary incontinence (SUI) after prostate surgery. The objective was to assess the effectiveness of the ATOMS device to treat male SUI as described in the literature. METHODS:Two independent reviewers identified studies eligible for a systematic review and meta-analysis of various sources written in English, German and Spanish, using the databases PubMed, EMBASE and Web of Science. We excluded studies on female incontinence. We employed the DerSimonian and Laird method for defining heterogeneity, calculating the grouped standard mean deviation (SMD). The primary objective of this review is the assessment of clinical efficacy based on the achievement of dryness after device adjustment, defined as use of no pad or one safety pad per day (PPD). The secondary objective was focused on analysing improvement of incontinence with the device. Magnitude of effect was calculated by analysing decrease in pad count (PPD) and/or in 24-h pad test. Number and severity of complications according to Clavien-Dindo classification were also reviewed. RESULTS:The pooled data of 1393 patients from 20 studies (13 retrospective and 7 prospective) showed that treatment with ATOMS resulted in a mean 67% dryness rate and 90% improvement after adjustment. Mean total number of system fillings per patient was 2.4. Mean pad count and 24-h pad test decrease were - 4.14 PPD and - 443 cc, respectively. There is significant heterogeneity of the sample analysed, mainly based on variable baseline severity of incontinence, proportion of patients treated with irradiation and different generation devices. Proportion of irradiated patients affected dryness rate (p = 0.0014), together with baseline severity of incontinence (p = 0.0035) and different generation device used (p < 0.0001). Standardized mean follow-up was 20.9 months, with complications occurring in 16.4% (major complications 3.0%) and explantations in 5.75%. No randomized study has been developed so far to compare ATOMS to other devices for treating male SUI. CONCLUSION:Despite the evidence being exclusively based on descriptive studies and limited follow-up, ATOMS has proven to be a safe alternative to treat different degrees of male SUI after prostate surgery. Better results are evidenced for patients with less than 6 PPD before implantation, non-irradiated patients and use of third-generation device with silicone-covered pre-attached scrotal port.

Project description:BackgroundStress 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/designMen 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.DiscussionA 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 registrationInternational Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.

Project description:BackgroundMidurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications.MethodsWe performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points.ResultsA total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life.ConclusionsThe 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Dataset Information

Outcomes of a Series of Patients with Post-Prostatectomy Incontinence Treated with an Adjustable Transobturator Male System or Artificial Urinary Sphincter.

Introduction

Methods

Results

Publications

Outcomes of a Series of Patients with Post-Prostatectomy Incontinence Treated with an Adjustable Transobturator Male System or Artificial Urinary Sphincter.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets