Safety considerations for synthetic sling surgery

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Abstract

Implantation of a synthetic midurethral sling (SMUS) is the most commonly performed anti-incontinence operation in women worldwide. The effectiveness of the SMUS is comparable to that of the historical gold standards--autologous fascial slings and the Burch colposuspension. Much controversy, however, has evolved regarding the safety of this type of sling. Overall, the quality of the studies with respect to assessing risks of SMUS-associated complications is currently poor. The most common risks in patients with SMUS include urethral obstruction requiring surgery (2.3% of patients with SMUS), vaginal, bladder and/or urethral erosion requiring surgery (1.8%) and refractory chronic pain (4.1%); these data likely represent the minimum risks. In addition, the failure rate of SMUS implantation surgery is probably at least 5% in patients with stress urinary incontinence (SUI). Furthermore, at least one-third of patients undergoing sling excision surgery develop recurrent SUI. Considering the additional risks of refractory overactive bladder, fistulas and bowel perforations, among others, the overall risk of a negative outcome after SMUS implantation surgery is ≥15%.

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Macrophages and inflammatory mediators in tissue injury.

D Laskin, K Pendino (1995)

Tissue injury induced by a diverse group of xenobiotics appears to involve both direct and indirect damage to target cells. Thus, while chemicals may act directly on target cells resulting in toxicity, they may also act indirectly by recruiting and activating resident and inflammatory tissue macrophages. Macrophages are potent secretory cells that release an array of mediators, including proinflammatory and cytotoxic cytokines and growth factors, bioactive lipids, hydrolytic enzymes, reactive oxygen intermediates, and nitric oxide--each of which has been implicated in the pathogenesis of tissue injury. The potential role of macrophages and their mediators in tissue injury has been extensively investigated in the lung and the liver. In both of these tissues, xenobiotics induce localized macrophage accumulation and mediator release. Furthermore, when macrophage functioning is blocked, pulmonary and hepatic injury-induced agents such as ozone, bleomycin, acetaminophen, carbon tetrachloride, and galactosamine are reduced. These data provide direct support for the hypothesis that macrophages and the mediators they release contribute to xenobiotic-induced tissue injury.

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Persistence with prescribed antimuscarinic therapy for overactive bladder: a UK experience.

Adrian S. Wagg, Carolyn Fahey, Emad Siddiqui … (2012)

Study Type--Therapy (prevalence) Level of Evidence 2b. What's known on the subject? and What does the study add? Persistence with long-term medication in chronic diseases is typically low and that for overactive bladder medication is lower than average. Sub-optimal persistence is a major challenge for the successful management of overactive bladder. Using UK prescription data, persistence was generally low across the range of antimuscarinics. Patients aged 60 years and above were more likely to persist with prescribed oral antimuscarinic drugs than younger patients (40-59 years). Solifenacin was consistently associated with the highest rate of persistence compared with the other antimuscarinics included in the study • To describe the level of persistence for patients receiving antimuscarinics for overactive bladder (OAB) over a 12-month period based on real prescription data from the UK. • To investigate patterns of persistence with oral antimuscarinic drugs prescribed for OAB, across different age groups. • UK prescription data from a longitudinal patient database were analysed retrospectively to assess persistence with darifenacin, flavoxate, oxybutynin (extended release [ER] and immediate release [IR]), propiverine, solifenacin, tolterodine (ER/IR) and trospium. • Data were extracted from the medical records of >1,200,000 registered patients via general practice software, and anonymized prescription data were collated for all eligible patients with documented OAB (n = 4833). • Data were collected on patients who started treatment between January 2007 and December 2007 and were collected up to December 2008, to allow each patient a full 12-month potential treatment period. Failure of persistence was declared after a gap of at least 1.5 times the length of the period of the most recent prescription. • The analysis included only patients who were new to a course of treatment (i.e. who had not been prescribed that particular treatment or dosage for at least 6 months before the study period). • The number of patients prescribed each antimuscarinic drug varied from 23 for darifenacin to 1758 for tolterodine ER. • The longest mean persistence was reported for solifenacin (187 days versus 77-157 days for the other treatments). • At 3 months, the proportions of patients still on their original treatment were: solifenacin 58%, darifenacin 52%, tolterodine ER 47%, propiverine 47%, tolterodine IR 46%, oxybutynin ER 44%, trospium 42%, oxybutynin IR 40%, flavoxate 28%. • At 12 months, the proportions of patients still on their original treatment were: solifenacin 35%, tolterodine ER 28%, propiverine 27%, oxybutynin ER 26%, trospium 26%, tolterodine IR 24%, oxybutynin IR 22%, darifenacin 17%, flavoxate 14%. • In a sub-analysis stratified by age, patients aged ≥ 60 years were more likely to persist with prescribed therapy over the 12-month period than those aged <60 years. • Twelve months after the initial prescription, persistence rates with pharmacotherapy in the context of OAB are generally low. • Solifenacin was associated with higher levels of persistence compared with other prescribed antimuscarinic agents. • Older people are more likely than younger patients to persist with prescribed therapy. Further studies are required to understand this finding and why patients are more likely to persist with one drug rather than another. © 2012 THE AUTHORS. BJU INTERNATIONAL © 2012 BJU INTERNATIONAL.

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Retropubic versus transobturator midurethral slings for stress incontinence.

Holly Richter, Michael Albo, Halina M. Zyczynski … (2010)

Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. We 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. A 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. The 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.) 2010 Massachusetts Medical Society