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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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2.
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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3.
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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Abstract
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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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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Urethral injection therapy for urinary incontinence in women.
Kirchin, V, Page, T, Keegan, PE, Atiemo, K, Cody, JD, McClinton, S
The Cochrane database of systematic reviews. 2012;(2):CD003881
Abstract
BACKGROUND Periurethral or transurethral injection of bulking agents is a minimally invasive surgical procedure used for the treatment of stress urinary incontinence 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 with respect to continence grade (risk ratio (RR) 0.7, 95% confidence interval (CI) 0.52 to 0.94) and quality of life (RR 0.54, 95% CI 0.16 to 0.92). Another, 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) 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.
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Urethral bulking: a urology perspective.
Reynolds, WS, Dmochowski, RR
The Urologic clinics of North America. 2012;(3):279-87
Abstract
Urethral bulking therapy (UBT) is a minimally invasive procedure for stress urinary incontinence that is beneficial for properly selected patients. Many different materials are available for UBT, although none fulfill all the qualities of an ideal agent. In general, short-term clinical results are encouraging; however, over longer follow-up, results are disappointing and retreatment is often necessary. Proper patient selection and management of patient expectations are paramount to successful application of UBT.
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Bulking agents: a urogynecology perspective.
Zoorob, D, Karram, M
The Urologic clinics of North America. 2012;(3):273-7
Abstract
A bulking agent is a material injected into the wall of the urethra to improve urethral coaptation in women suffering from stress incontinence. The concept was initially described in the 1930s when sodium morrhuate and paraffin were used to augment urethral resistance. Sclerosing agents were also used for inducing permanent urethral scaring to improve urinary leakage. Eventually, collagen and autologous fat were found to be efficacious, and only collagen demonstrated proven safety and endured extensive testing, becoming the gold standard for injectable agents. Since then, multiple other products have been developed by the industry, each with its particular success rates and complications.
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Periurethral injection therapy for urinary incontinence in women.
Keegan, PE, Atiemo, K, Cody, J, McClinton, S, Pickard, R
The Cochrane database of systematic reviews. 2007;(3):CD003881
Abstract
BACKGROUND Periurethral or transurethral injection of bulking agents is a surgical procedure most often used for the treatment of stress urinary incontinence a common, troublesome symptom amongst adult women. OBJECTIVES To assess the effects of periurethral/transurethral injection therapy in the treatment of urinary incontinence in women. SEARCH STRATEGY We searched the Cochrane Incontinence Group Specialised Trials Register (28 February 2007), MEDLINE (January 1996 to March 2007, PREMEDLINE (7 February 2007) 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/transurethral injection therapy. DATA COLLECTION AND ANALYSIS Two reviewers independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently using a standard form and clarification concerning possible unreported data sought directly from the investigators. MAIN RESULTS We identified twelve trials including 1318 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis. Injection of autologous fat was compared to placebo in a study of 68 women which was terminated early because of safety concerns. No differences in subjective or objective outcome were found in the two groups. No studies were found comparing injection therapy with conservative treatment. Two studies that compared injection with surgical management found significantly better objective outcome in the surgical group. Eight studies compared different agents - all results had wide confidence intervals. Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol and carbon spheres gave improvements equivalent to collagen. Porcine dermal implant gave improvements comparable to silicone at six months. A comparison of periurethral and transurethral methods of delivery of the bulking agent found similar outcome but a higher rate of early complications in the periurethral group. AUTHORS' CONCLUSIONS Despite five additional trials, this updated review is still an unsatisfactory basis for practice. The trials were small and generally of moderate quality. The only evidence of benefit comes for within-group short-term changes following injection. The finding that placebo saline injection was followed by a similar symptomatic improvement questions the mechanism of any effects. There were no trials in comparison with pelvic floor muscle training -the obvious non-surgical comparator. Greater symptomatic improvement was observed after surgery, although these advantages need to be set against likely higher risks. No clear-cut conclusions could be drawn from trials comparing alternative agents; one small trial suggests that periurethral injection may carry more risks than transurethral injection. The single trial of autologous fat provides a reminder that periurethral injections can occasionally cause serious side-effects. Pending further evidence, injection therapy may represent a useful option for short-term symptomatic relief amongst selected women with co-morbidity that precludes anaesthesia - two or three injections are likely to be required to achieve a satisfactory result.
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Review of the available urethral bulking agents.
Lightner, DJ
Current opinion in urology. 2002;(4):333-8
Abstract
PURPOSE OF REVIEW Newer tissue bulking agents used to treat stress urinary incontinence and vesicoureteral reflux provide for similar rates of success as older agents, but with greater safety and hopefully with greater durability. We review the new studies on the development and on the current trials of bulking agents. RECENT FINDINGS Recent reports suggest that periurethral bulking agents are as effective for genuine stress urinary continence as for intrinsic sphincter deficiency, expanding the indications for injectable agents to include patients desiring less invasive procedures due to personal preference or as a result of medical necessity. Newer bulking agents, Durasphere and Macroplastique, appear safe and as efficacious as older agents in early trials. Durability remains a question for these agents. Injectable tissue matrices and autologous cells may prove useful in the future. SUMMARY If durable and safe, these minimally invasive bulking agents may prove useful for all types of stress urinary incontinence. The price of minimal invasiveness may be lower efficacy, but their use does not compromise further therapy, should it be needed.