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Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols.
Willis-Gray, MG, Wu, JM, Field, C, Pulliam, S, Husk, KE, Brueseke, TJ, Geller, EJ, Connolly, A, Dieter, AA
Female pelvic medicine & reconstructive surgery. 2021;(2):e256-e260
Abstract
OBJECTIVES This study aimed to compare a backfill-assisted voiding trial (VT) with and without a postvoid residual (PVR) after pelvic reconstructive surgery. METHODS This was a nonblinded randomized controlled trial of women undergoing pelvic organ prolapse and/or stress incontinence surgery. Participants were randomized immediately after surgery to either a PVR VT or a PVR-free VT. Our primary outcome was the rate of VT failure at discharge. Secondary outcomes included days of catheterization, urinary tract infection (UTI), and prolonged voiding dysfunction. With a power of 80% and an α of 0.05, we needed 126 participants to detect a 25% difference in VT failure (60% in PVR VT vs 35% in PVR-free VT). RESULTS Participants were enrolled from March 2017 to October 2017. Of the 150 participants, mean age was 59 years, and 33% underwent vaginal hysterectomy, 48% underwent anterior repair, and 75% underwent midurethral sling. Seventy-five (50%) were randomized to PVR VT and 75 (50%) to PVR-free VT, with no differences in baseline demographic or intraoperative characteristics between the 2 groups. Our primary outcome, VT failure, was not significantly different (53% PVR VT vs 53% PVR-free VT, P = 1.0). There were no significant differences in days of postoperative catheterization (1 [0, 4] in PVR VT vs 1 [0, 4] in PVR-free VT, P = 0.90), UTI (20% PVR VT vs 20% PVR-free VT, P = 1.0), or postoperative voiding dysfunction (4% PVR VT vs 5% PVR-free VT, P = 1.0). CONCLUSIONS When performing a backfill-assisted VT, checking a PVR does not affect VT failure, postoperative duration of catheterization, UTI, or voiding dysfunction.
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Self-Perceived Improvement in Bladder Health After Viewing a Novel Tutorial on Knack Use: A Randomized Controlled Trial Pilot Study.
Miller, JM, Hawthorne, KM, Park, L, Tolbert, M, Bies, K, Garcia, C, Misiunas, R, Newhouse, W, Smith, AR
Journal of women's health (2002). 2020;(10):1319-1327
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Abstract
Purpose: To test a novel bladder health tutorial on use of the Knack for overcoming bladder control challenges. The Knack-tutorial is a self-administered vignette-based instructional program on preempting bladder challenges in daily life (urgency, stress-leakage, or urge-leakage) through anticipatory, well-timed pelvic floor muscle contraction at the moment of challenge. Materials and Methods: This is a randomized controlled trial pilot test of 108 women with stress or mixed urinary incontinence. The Knack-tutorial group saw a 15-minute slide show with 10 vignettes portraying use of the Knack in daily life. The slide show format used inserted narrated videos, dubbed and animation enhanced pictures and cartoons, and automatic slide advancement. A control group saw a similarly constructed slide show on incorporating good diet/exercise habits. Outcomes were self-perceived improvement (yes/no, and as 0%-100%) 1 month after viewing the tutorial. Results: We enrolled 123 women, randomizing 64 to Knack-tutorial group and 59 to diet/exercise tutorial group. Eleven and one participant, respectively, did not return. Three did not fill out the self-perceived improvement report. Significant improvement was reported by 71% in the Knack-tutorial group compared to 25% in the diet/exercise group (p < 0.001). Self-perceived improvement was 21%-22% higher (Model I Est: 21.01, SE: 4.25, p < 0.001) in the Knack-tutorial group. Conclusions: An electronic tutorial viewed independent of a health care provider with vignettes showing Knack application to manage the everyday bladder challenges women face shows benefit of a magnitude that warrants more widespread use and rigorous testing. A professional remake of the intervention is now available (www.myconfidentbladder.com).
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Urethral bulking agents for female stress urinary incontinence.
Hussain, SM, Bray, R
Neurourology and urodynamics. 2019;(3):887-892
Abstract
Urethral bulking agents (UBAs) to treat stress urinary incontinence was first described in the 1930s, when paraffin was used to increase urethral resistance. Since then, several agents have been introduced to the market, with varying degrees of safety, efficacy, and durability. The agents currently available include calcium hydroxyl apatite (Coaptite®), carbon coated zirconium (Durasphere®); polydimethylsiloxane elastomer (Macroplastique®); and polyacrylamide hydrogel (Bulkamid®). The latest product, PDMS-U (Urolastic ®) is a silicone gel that polymerizes when injected. The short term efficacy of UBAs are generally encouraging; however, longer follow up results show the success rates are reduced and many women will require a repeat treatment. This review looks at the currently available UBAs, application techniques, and the clinical data on their safety and efficacy.
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Bulking for stress urinary incontinence in men: A systematic review.
Toia, B, Gresty, H, Pakzad, M, Hamid, R, Ockrim, J, Greenwell, T
Neurourology and urodynamics. 2019;(7):1804-1811
Abstract
AIMS: An updated literature review on outcomes in men treated with currently commercially available bulking agents was performed to determine whether this is a reasonable option in selected patients. METHODS The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework of systematic reviews. A comprehensive search of PubMed, Medline, and Embase was undertaken. Abstracts were independently screened by two investigators to include men with stress urinary incontinence treated with a peri-urethral injection of bulking agents currently available in the market. RESULTS Only eight original articles met the inclusion criteria. The bulking agents used were Macroplastique in five studies (total 123 patients), Opsys, Durasphere, and Urolastic in one study each (10, 7, and 2 patients, respectively). Only one study was randomized; Macroplastique vs AUS in men with mild or total incontinence. The included populations were heterogeneous and encompassed endoscopic, perineal, abdominal and laparoscopic prostate surgery as well as spinal cord injuries and urethral sphincter insufficiency. Significant dissimilarity was evident for the duration of incontinence (9-108 months), mean volume of bulking agent used (2.3-13.5 mL), number of cushions (1-5), depth and position of the cushions. The outcomes varied significantly, with reported dry rates between 0% and 83%. Outcomes were limited by relatively short follow-up in most studies. CONCLUSION Following initial enthusiasm and then dismay with collagen-based compounds, sparse and heterogeneous literature data were produced on newer non-migrating and nonabsorbable bulking agents. Some studies have suggested encouraging, if short term outcomes, however, future studies are needed in this field to support recommendations for widespread use.
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Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a mixed methods pilot for a randomised controlled trial.
Lausen, A, Marsland, L, Head, S, Jackson, J, Lausen, B
BMC women's health. 2018;(1):16
Abstract
BACKGROUND Urinary incontinence (UI) is a distressing condition affecting at least 5 million women in England and Wales. Traditionally, physiotherapy for UI comprises pelvic floor muscle training, but although evidence suggests this can be effective it is also recognised that benefits are often compromised by patient motivation and commitment. In addition, there is increasing recognition that physical symptoms alone are poor indicators of the impact of incontinence on individuals' lives. Consequently, more holistic approaches to the treatment of UI, such as Modified Pilates (MP) have been recommended. This study aimed to provide preliminary findings about the effectiveness of a 6-week course of MP classes as an adjunct to standard physiotherapy care for UI, and to test the feasibility of a randomised controlled trial (RCT) design. METHODS The study design was a single centre pilot RCT, plus qualitative interviews. 73 women referred to Women's Health Physiotherapy Services for UI at Colchester Hospital University NHS Foundation Trust were randomly assigned to two groups: a 6-week course of MP classes in addition to standard physiotherapy care (intervention) or standard physiotherapy care only (control). Main outcome measures were self-reported UI, quality of life and self-esteem at baseline (T1), completion of treatment (T2), and 5 months after randomisation (T3). Qualitative interviews were conducted with a subgroup at T2 and T3. Due to the nature of the intervention blinding of participants, physiotherapists and researchers was not feasible. RESULTS Post-intervention data revealed a range of benefits for women who attended MP classes and who had lower symptom severity at baseline: improved self-esteem (p = 0.032), decreased social embarrassment (p = 0.026) and lower impact on normal daily activities (p = 0.025). In contrast, women with higher symptom severity showed improvement in their personal relationships (p = 0.017). Qualitative analysis supported these findings and also indicated that MP classes could positively influence attitudes to exercise, diet and wellbeing. CONCLUSIONS A definitive RCT is feasible but will require a large sample size to inform clinical practice. TRIAL REGISTRATION ISRCTN74075972 Registered 12/12/12 (Retrospectively registered).
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Urethral injection therapy for urinary incontinence in women.
Kirchin, V, Page, T, Keegan, PE, Atiemo, KO, Cody, JD, McClinton, S, Aluko, P
The Cochrane database of systematic reviews. 2017;(7):CD003881
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BACKGROUND Urinary incontinence imposes a significant health and economic burden to society. Periurethral or transurethral injection of bulking agents is a minimally invasive surgical procedure used as one the surgical treatments of stress urinary incontinence (SUI) in adult women. OBJECTIVES To assess the effects of periurethral or transurethral injection therapy on the cure or improvement of urinary incontinence in women. SEARCH METHODS We searched the Cochrane Incontinence Group Specialised Trials Register (searched 8 November 2010) and the reference lists of relevant articles. SELECTION CRITERIA All randomised or quasi-randomised controlled trials of treatment for urinary incontinence in which at least one management arm involved periurethral or transurethral injection therapy. DATA COLLECTION AND ANALYSIS Two review authors independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently and clarification concerning possible unreported data sought directly from the investigators. MAIN RESULTS Excluding duplicate reports, we identified 14 trials (excluding one that was subsequently withdrawn from publication and not included in this analysis) including 2004 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis because they all came from separate trials. Trials were small and generally of moderate quality.One trial of 45 women that compared injection therapy with conservative treatment showed early benefit for the injectable therapy with respect to continence grade (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.52 to 0.94) and quality of life (mean difference (MD) 0.54, 95% CI 0.16 to 0.92). Another trial, comparing Injection of autologous fat with placebo, terminated early because of safety concerns. Two trials that compared injection with surgical management found significantly better objective cure in the surgical group (RR 4.77, 95% CI 1.96 to 11.64; and RR 1.69, 95% CI 1.02 to 2.79), although the latter trial data did not reach statistical significance if an intention-to-treat analysis was used.Eight trials compared different agents and all results had wide confidence intervals. Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol, carbon spheres and dextranomer hyaluronic acid combination gave improvements which were not shown to be more or less efficacious than collagen. Dextranomer hyaluronic acid compound treated patients appeared to have significantly higher rates of injection site complications (16% with the hyaluronic acid compound versus none with collagen; RR 37.78, 95% CI 2.34 to 610.12) and this product has now been withdrawn from the market.A comparison of periurethral and transurethral methods of injection found similar outcomes but a higher (though not statistically significant) rate of early complications in the periurethral group. One trial of 30 women showed a weak (but not clinically significant) advantage for patient satisfaction (data not suitable for analysis in RevMan) after mid-urethral injection in comparison to bladder neck injection but with no demonstrable difference in continence levels. AUTHORS' CONCLUSIONS The available evidence base remains insufficient to guide practice. In addition, the finding that placebo saline injection was followed by a similar symptomatic improvement to bulking agent injection raises questions about the mechanism of any beneficial effects. One small trial comparing silicone particles with pelvic floor muscle training was suggestive of benefit at three months but it is not known if this was sustained, and the treatment was associated with high levels of postoperative retention and dysuria. Greater symptomatic improvement was observed with surgical treatments, though the advantages need to be set against likely higher risks. No clear-cut conclusions could be drawn from trials comparing alternative agents, although dextranomer hyaluronic acid was associated with more local side effects and is no longer commercially available for this indication. There is insufficient evidence to show superiority of mid-urethral or bladder neck injection. The single trial of autologous fat provides a reminder that periurethral injections can occasionally cause serious side effects. Also, a Brief Economic Commentary (BEC) identified three studies suggesting that urethral bulking agent might be more cost-effective compared with retropubic mid-urethral slings, transobturator or traditional sling procedure when used as an initial treatment in women without hypermobility or as a follow-up to surgery failure provided injection is kept minimal. However, urethral bulking agent might not be cost-effective when compared with traditional sling as an initial treatment of SUI when a patient is followed up for a longer period (15 months post-surgery).
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Minimal Device Encrustation on Vesair Intravesical Balloons in the Treatment of Stress Urinary Incontinence: Analysis of Balloons Removed from Women in the SOLECT Trial.
van Koeveringe, GA, De Wachter, S, Zuckerman, JM, Tommaselli, G, de Wildt, MJ, Everaert, KCM, Michielsen, DPJ, Wyndaele, JJ
Advances in therapy. 2017;(7):1686-1694
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INTRODUCTION Encrustation of urinary biomaterials is common; however, the incidence of surface deposition on the Vesair® intravesical pressure-attenuation balloon has not been previously reported. The purpose of this analysis is to determine the incidence and potential risk factors for encrustation of the Vesair intravesical balloon. METHODS The SOLECT trial is a prospective randomized controlled trial conducted at several European centers to evaluate the safety and efficacy of the Vesair balloon for the treatment of female stress urinary incontinence (SUI). Women included in the study demonstrated SUI symptoms for more than 12 months without complicating factors, such as history of recurrent urinary tract infections or nephrolithiasis. All balloons removed from women enrolled in the SOLECT trial were analyzed for surface characteristics and encrustation. Surface deposition severity was quantified and composition analyzed with infrared spectroscopy and scanning electron microscopy. Incidence of surface deposition was tabulated and risk factors analyzed. RESULTS One hundred and five balloons removed from 75 women were included in this analysis. Measurable stone deposition of less than 1.5 mm was found on four balloons (3.8%), surface granules were noted on 42 (40.0%), surface film on 11 (10.5%), and both granules and film on two (1.9%). Analysis identified calcium oxalate both in measurable encrustation deposits as well as those with surface granulation. Pooled analysis found that dwell time was a risk factor for calcium deposition. CONCLUSION The rate of encrustation on the Vesair intravesical balloon is low and does not appear to increase the rate of adverse outcomes or reduce clinical efficacy. FUNDING Solace Therapeutics, Inc.
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Comparative study of polyvinylidene fluoride and polypropylene suburethral slings in the treatment of female stress urinary incontinence.
Sabadell, J, Larrain, F, Gracia-Perez-Bonfils, A, Montero-Armengol, A, Salicrú, S, Gil-Moreno, A, Poza, JL
The journal of obstetrics and gynaecology research. 2016;(3):291-6
Abstract
Aims Evaluate the effectiveness and safety of polyvinylidene fluoride (PVDF) transobturator suburethral slings/tapes (TOTs) in the treatment of stress urinary incontinence, and compare them to polypropylene (PP) slings. Material and Methods A retrospective cohort study was performed on women treated with a TOT procedure at Vall d'Hebron Hospital between February 2010 and May 2013. A PVDF sling was used in surgeries on 23 women. A comparison group was randomly selected among all women treated with a PP sling in a 1:4 ratio (n = 92). Failure incidence was analyzed by Kaplan-Meier survival functions and a multivariate Cox regression model. Results Both groups were similar in their initial characteristics. The median follow-up was 24.6 months in the PP group and 21.3 months in the PVDF group. The survival functions showed a higher incidence of failures in the PP group, primarily because of obstructive symptoms. However, the differences were not statistically significant (hazard ratio of failure of PP vs PVDF 4.31; 95% confidence interval 0.56-33.05). Complication rates did not differ between the two groups. More cases of voiding dysfunction were observed in the PP group. Conclusions Polyvinylidene fluoride suburethral tapes have been found to have an effectiveness and safety comparable to PP tapes.
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Urinary incontinence in frail elderly persons: Report from the 5th International Consultation on Incontinence.
Wagg, A, Gibson, W, Ostaszkiewicz, J, Johnson, T, Markland, A, Palmer, MH, Kuchel, G, Szonyi, G, Kirschner-Hermanns, R
Neurourology and urodynamics. 2015;(5):398-406
Abstract
BACKGROUND Evidence based guidelines for the management of frail older persons with urinary incontinence are rare. Those produced by the International Consultation on Incontinence represent an authoritative set of recommendations spanning all aspects of management. AIMS To update the recommendations of the 4th ICI. MATERIALS AND METHODS A series of systematic reviews and evidence updates were performed by members of the working group in order to update the 2009 recommendations. The resulting guidelines were presented at the 2012 meeting of the European Associatioon of Urology. RESULTS Along with the revision of the treatment algorithm and accompanying text. There have been significant advances in several areas including pharmacological treatment of overactive bladder. DISCUSSION The committee continue to notes the relative paucity of data concerning frail older persons and draw attention to knowledge gaps in this area.
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The effect of angiotensin inhibition on urinary incontinence: data from the National Health and Nutrition Examination Survey (2001-2008).
Elliott, CS, Comiter, CV
Neurourology and urodynamics. 2014;(8):1178-81
Abstract
INTRODUCTION Local renin-angiotensin systems exist within the genitourinary tract, specifically in the bladder and urethra. Experimental data suggest that angiotensin receptor blockade with either angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) decreases both detrusor overactivity and urethral sphincter tone leading to decreased urge incontinence (UUI) and increased stress urinary incontinence (SUI). This has not been examined in a human population. METHODS Data from the National Health and Nutrition Examination Survey (NHANES) was accessed for the years 2001-2008. Multivariate logistic regression was used for modeling. RESULTS We studied 8,754 females and 8,886 males who met inclusion criteria. Use of ACE inhibitors or ARBs was not associated with a change in SUI in either men or women. In men, use of an ACE inhibitor or ARB was associated with a statistically significant 25-30% decrease in UUI (monthly or any urge incontinence). A similar, albeit non-significant trend was also seen for daily and weekly UUI. Other antihypertensive medications (diuretics, beta-blockers, calcium-channel blockers) were not associated with a decrease in UUI. In subanalysis, duration of ACE inhibitor or ARB use did not alter the strength of the effect on UUI nor did an elevated prostate specific antigen (PSA) level (used as a surrogate for bladder outlet obstruction due to benign prostatic hypertrophy). ACE inhibitor and ARB use did not affect UUI rates in women, though did show a trend for improvement in nulliparous women without SUI. CONCLUSION Angiotensin receptor blockade may be a viable treatment approach for the treatment of UUI, especially in men.