Dataset Information

AdVance™ male sling for stress urinary incontinence: Long-term follow-up and patient satisfaction.

ABSTRACT:

Objectives

To evaluate long-term effects, complications and satisfaction among patients treated with AdVance™ and AdVance™ XP slings (AS) at a Norwegian specialist care hospital.

Materials and methods

Patients who had an AS implanted due to stress urinary incontinence (SUI) 2009-2016 were identified retrospectively. Demographic and perioperative data were extracted from electronic patient files. We did a patient-reported outcome measure (PROM) survey with the Expanded Prostate Cancer Index Composite (EPIC-26) urinary domain and a Satisfaction Questionnaire (SQ) 2018-2020. Cure was defined as use of ≤1 pad/day.

Results

The AS was implanted in 165 patients, mainly due to mild to moderate SUI (median leakage 112 g, range 13-589 g/24 h). Preoperative urodynamics showed mild detrusor overactivity (DO) in 11 patients. At 6-week follow-up, 148 patients (90%) were cured. The most common complication was urinary retention (N = 38), transient in 32 patients (range 1-42 days). Two patients were later operated with division of the sling due to persistent retention. During clinical follow-up of up to 12 years, 27 patients were reoperated due to persistent/recurrent incontinence. The PROM survey was sent to 125 patients and 115 (92%) replied at median 73 (20-134) months postoperatively. Ninety-one (79%) used ≤1 pads/day, 97 (85%) were satisfied, one patient-reported pain. Regression analyses showed that failure (>1 pad/day) was significantly associated with a higher amount of leakage preoperatively and at the 6-week follow-up. Total cure rate in the complete cohort was 64% at median 73 (20-134) months follow-up.

Conclusions

The AS shows good and persistent long-term results in patients with mild to moderate SUI. The only identified risk factor for long-term failure was higher amount of leakage preoperatively. The incidence of high body mass index (BMI), DO and previous radiotherapy was low and not significantly associated with failure but is still considered risk factors.

SUBMITTER: Boe RT

PROVIDER: S-EPMC10764177 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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Publications

AdVance™ male sling for stress urinary incontinence: Long-term follow-up and patient satisfaction.

Boe Rebecca Therese RT Nilsen Ole Jacob OJ Holm Henriette Veiby HV

BJUI compass 20230920 1

<h4>Objectives</h4>To evaluate long-term effects, complications and satisfaction among patients treated with AdVance™ and AdVance™ XP slings (AS) at a Norwegian specialist care hospital.<h4>Materials and methods</h4>Patients who had an AS implanted due to stress urinary incontinence (SUI) 2009-2016 were identified retrospectively. Demographic and perioperative data were extracted from electronic patient files. We did a patient-reported outcome measure (PROM) survey with the Expanded Prostate Can ...[more]

PMID: 38179034

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Project description:ObjectiveTo identify factors that may contribute to patient satisfaction with outcome in women who received retropubic and transobturator midurethral slings.MethodsSatisfaction was assessed 12 months postsurgery as a planned analysis in 597 participants from a multicenter randomized trial comparing retropubic with transobturator midurethral slings using the Incontinence Surgery Satisfaction Questionnaire. Significantly related variables associated with satisfaction in univariable analyses were entered into multivariable logistic regression models to test their independent association with satisfaction.ResultsOne year after surgery, 264 (88.6%) in the retropubic group and 263 (88.0%) in the transobturator group completed satisfaction questionnaires. Both treatment groups demonstrated a high level of satisfaction with respect to urine leakage (retropubic 85.9% compared with transobturator 90.0%; P=.52), urgency to urinate, frequency of urination, capability of physical activity, social activity, ability to engage in sexual activity, and from an emotional standpoint. Baseline characteristics associated with reduced satisfaction were higher Medical, Epidemiologic, and Social Aspects of Aging Questionnaire urgency subscale scores, detrusor overactivity, and diabetes mellitus. The severity of both objective (frequency of incontinence episodes, pad test weight) and subjective (Incontinence Impact Questionnaire and Urogenital Distress Inventory score) measures of incontinence at baseline and the patients' perceptions of preoperative severity of incontinence and expectations of achieving postoperative cure or improvement were not statistically different between satisfied and unsatisfied patients. In the final multivariable model, satisfaction was associated with overall treatment success (odds ratio [OR] 2.57, 95% confidence interval [CI] 1.29-5.13], greater reduction in Urogenital Distress Inventory (OR 0.97, 95% CI 0.96-0.98) and Incontinence Impact Questionnaire scores (OR 0.99, 95% CI 0.98-0.99), and fewer complications (OR 0.55, 95% CI 0.30-0.99).ConclusionThe high level of satisfaction seen after midurethral sling procedures is associated with greater objective and patient-perceived improvement of stress incontinence and fewer complications.Clinical trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00325039.Level of evidenceII.

Project description:ImportanceThere is concern about outcomes of midurethral mesh sling insertion for women with stress urinary incontinence. However, there is little evidence on long-term outcomes.ObjectiveTo examine long-term mesh removal and reoperation rates in women who had a midurethral mesh sling insertion for stress urinary incontinence.Design, setting, and participantsThis population-based retrospective cohort study included 95 057 women aged 18 years or older who had a first-ever midurethral mesh sling insertion for stress urinary incontinence in the National Health Service hospitals in England between April 1, 2006, and December 31, 2015. Women were followed up until April 1, 2016.ExposuresPatient and hospital factors and retropubic or transobturator mesh sling insertions.Main outcomes and measuresThe primary outcome was the risk of midurethral mesh sling removal (partial or total) and secondary outcomes were reoperation for stress urinary incontinence and any reoperation including mesh removal, calculated with death as competing risk. A multivariable Fine-Gray model was used to calculate subdistribution hazard ratios as estimates of relative risk.ResultsThe study population consisted of 95 057 women (median age, 51 years; interquartile range, 44-61 years) with first midurethral mesh sling insertion, including 60 194 with retropubic insertion and 34 863 with transobturator insertion. The median follow-up time was 5.5 years (interquartile range, 3.2-7.5 years). The rate of midurethral mesh sling removal was 1.4% (95% CI, 1.3%-1.4%) at 1 year, 2.7% (95% CI, 2.6%-2.8%) at 5 years, and 3.3% (95% CI, 3.2%-3.4%) at 9 years. Risk of removal declined with age. The 9-year removal risk after transobturator insertion (2.7% [95% CI, 2.4%-2.9%]) was lower than the risk after retropubic insertion (3.6% [95% CI, 3.5%-3.8%]; subdistribution hazard ratio, 0.72 [95% CI, 0.62-0.84]). The rate of reoperation for stress urinary incontinence was 1.3% (95% CI, 1.3%-1.4%) at 1 year, 3.5% (95% CI, 3.4%-3.6%) at 5 years, and 4.5% (95% CI, 4.3%-4.7%) at 9 years. The rate of any reoperation, including mesh removal, was 2.6% (95% CI, 2.5%-2.7%) at 1 year, 5.5% (95% CI, 5.4%-5.7%) at 5 years, and 6.9% (95% CI, 6.7%-7.1%) at 9 years.Conclusions and relevanceAmong women undergoing midurethral mesh sling insertion, the rate of mesh sling removal at 9 years was estimated as 3.3%. These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence.

Project description:Background and objectiveStress urinary incontinence (SUI) is the involuntary loss of urine affecting 1-3% of the male population. To manage leakage, patients may try a plethora of penile clamps. and may even consider artificial urinary sphincters (AUS) or sling implantation. We aimed to synthesize the evolution of the modern clamp, AUS, and sling through a comprehensive patent search.MethodsPatents were found through the databases of United States Patent and Trademark Office (USPTO), GooglePatents, and the World Intellectual Property Office Patentscope, covering patents published through January 6, 2024.Key content and findingsWe found 30 different patents (10 clamps, 13 AUS, and 7 slings), including the patents pertaining to the functionalities and design of five commercially available penile clamps, the American Medical System 800 (AMS 800), the InVance, AdVance, AdVance XP, and Virtue Slings. The clamps, spanning back to 1938 with Bard Cunningham's clamp, have undergone significant refinements. For example, inventors such as Edson S. Outwin and Juan F. V. Wiesner, have modified the location of the primary pressure point. Accessibility has also improved with inventors, such as Gerald French and John W. Timmons, fastening the clamps with Velcro®, as opposed to the screw and ratchet catch closing mechanism, as in Cunningham's clamp. Similarly, the AUS has greatly evolved since Foley's 1947 "Artificial Sphincter and Method", which was the primary AUS precedent to Mark Polyak's AUS invention, which covered the essential elements and functionalities, such as the incorporation of a balloon reservoir, for the AMS 800. In addressing AUS limitations, inventors such as David W. Anderson and Louisa Thomas have created non-hydraulic AUSs. Likewise, the male sling has seen an evolution in the method of securement, from the use of fixed bone anchors in the InVance sling to the transobturator route used in the AdVance XP, avoiding bone complications. Additionally, innovation in sling adjustment of urethral compression allows for adjustable urethral elevation and distal compression respectively. Recent patents have claimed technological integration for clamps, AUS, and slings, especially concerning automation.ConclusionsOverall, patents have built upon the limitations of previous devices. However, there is still a need to innovate for increased clamp comfort and reduced reoperation rates for the AUS and sling.

Project description:BackgroundFixed and adjustable male slings for the treatment of male urinary stress incontinence became increasingly popular during the last decade. Although fixed slings are recommended for the treatment of mild to moderate stress urinary incontinence, there is still a lack of evidence regarding the precise indication for an adjustable male sling. Furthermore, there is still no evidence that one type of male sling is superior to another. However, both, adjustable and fixed slings, are commonly utilized in daily clinical practice. This current investigation aims to evaluate the differences between fixed and adjustable male slings regarding indications, complication rates and functional outcome in the treatment of male stress urinary incontinence in current clinical practice.MethodsA total of 294 patients with a fixed and 176 patients with an adjustable male sling were evaluated in a multicenter single arm cohort trial. Data collection was performed retrospectively according the medical record. Functional outcome was prospectively analyzed by standardized, validated questionnaires. Descriptive statistics was performed to present patient characteristics, complication rates and functional outcome. A chi2-test for categorical and independent t-test for continuous variables was performed to identify heterogeneity between the groups and to correlate preoperative characteristics with the outcome. A P value <0.05 was considered statistically significant.ResultsPatients with higher degree of urinary incontinence (P<0.001) and risk factors such as history of pelvic irradiation (P<0.001) or prior surgery for urethral stricture (P=0.032) were more likely to receive an adjustable MS. Complication rates were comparable except for infection (P=0.009, 0 vs. 2.3%) and pain (P=0.001, 1.7% vs. 11.3%) which occurred more frequently in adjustable slings. Functional outcome according validated questionnaires demonstrated no differences between fixed and adjustable male slings.ConclusionsAdjustable male slings are more frequently utilized in patients with higher degree of incontinence and risk factors compared to fixed slings. No differences could be identified between functional outcome which may imply an advantage for adjustability. However, pain and infection rates were significantly higher in adjustable MS and should be considered in the decision process for sling type.

Dataset Information

AdVance™ male sling for stress urinary incontinence: Long-term follow-up and patient satisfaction.

Objectives

Materials and methods

Results

Conclusions

Publications

AdVance™ male sling for stress urinary incontinence: Long-term follow-up and patient satisfaction.

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