Intraoperative Gentamicin Intravesical Instillation for Prevention of Urinary Tract Infection After Urogynecologic Surgery: A Randomized Controlled Trial

Abstract

Importance Currently available evidence for efficacy of postoperative antibiotics to prevent postoperative urinary tract infection (UTI) conflicts. Oral antibiotics rely on patient adherence and can cause unwanted systemic effects. Gentamicin is a broad-spectrum antibiotic with rapid bactericidal activity and, when administered intravesically, has no systemic absorption through intact urothelium. Objective We aimed to determine whether a single intravesical instillation of gentamicin at the conclusion of urogynecologic surgery would reduce the proportion of women treated for UTI within 6 weeks postoperatively compared with sham instillation. Study Design This was a multicenter, randomized (stratified by study site, route of prolapse repair ±suburethral sling, with balanced 1:1 randomization), participant-masked, sham-controlled, study. The primary outcome was the proportion of participants treated with antibiotics for UTI within 6 weeks postoperatively. An adjusted multivariable logistic regression model was constructed to determine predictors of postoperative UTI treatment. Results Three hundred seventy participants were randomized (gentamicin, 185; sham, 185), and data from 363 participants were analyzed (gentamicin, 183; sham, 180). Nineteen women in the gentamicin group and 20 women in the sham group were treated for UTI within 6 weeks postoperatively (10.4% vs 11.1%, P = 0.87). There were no adverse events related to the instillations. Increasing age (odds ratio, 1.028 [1.000–1.057]) and number of intraoperative transurethral instrumentations (odds ratio, 1.342 [1.080–1.668]) were independent predictors of postoperative UTI treatment. Conclusions In women undergoing urogynecologic surgery, postoperative intravesical gentamicin did not reduce the incidence of postoperative UTI. The number of intraoperative transurethral instrumentations is an important, potentially modifiable risk factor for postoperative UTI treatment.

SWOT and Root Cause Analyses of Antimicrobial Resistance to Oral Antimicrobial Treatment of Cystitis

“…The principle of the five "Ds" can be best illustrated by an intravesical gentamicin dose of 80 mg [155][156][157][158][159] (Figure 5B), delivering a bactericidal concentration with a 90% elimination of live bacteria within 3 h of administration, with a comparative lower incidence of AMR [140] and recurrence [37] than those reported with OAT [38,123]. As opposed to the urine and plasma plots of OAT shown in Figure 2B, the plot in Figure 5B is projected from a recent study on post-operative prophylaxis by intravesical gentamicin [160]. As depicted by the low plasma levels (red curve in Figure 5B), the limited The principle of the five "Ds" can be best illustrated by an intravesical gentamicin dose of 80 mg [155][156][157][158][159] (Figure 5B), delivering a bactericidal concentration with a 90% elimination of live bacteria within 3 h of administration, with a comparative lower incidence of AMR [140] and recurrence [37] than those reported with OAT [38,123].…”

“…As depicted by the low plasma levels (red curve in Figure 5B), the limited The principle of the five "Ds" can be best illustrated by an intravesical gentamicin dose of 80 mg [155][156][157][158][159] (Figure 5B), delivering a bactericidal concentration with a 90% elimination of live bacteria within 3 h of administration, with a comparative lower incidence of AMR [140] and recurrence [37] than those reported with OAT [38,123]. As opposed to the urine and plasma plots of OAT shown in Figure 2B, the plot in Figure 5B is projected from a recent study on post-operative prophylaxis by intravesical gentamicin [160]. As depicted by the low plasma levels (red curve in Figure 5B), the limited bioavailability of drugs from the bladder can allow the local administration of a drug concentration (yellow curve in Figure 5B) that would be in a toxic range if administered systemically by oral or intravenous route [154].…”

SWOT and Root Cause Analysis of Antimicrobial Resistance to Oral Antimicrobial Treatment of Cystitis

“…The principle of 5"D"s can be best illustrated by intravesical Gentamicin 80mg(Figure 4B), delivering a bactericidal concentration with 90% elimination of live bacteria within 3h with a comparative lower incidence of AMR [89] and recurrence [90] than reported with OAT [14,79]. As opposed to urine and plasma plots of OAT shown in Figure 2B, the plot of Figure 4B is projected from a recent study on post-operative prophylaxis by intravesical Gentamicin [91]. As depicted by the low plasma levels (red curve of Figure 4B), the limited bioavailability from bladder can allow local administration of drug concentration (yellow curve of Figure 4B) that would be in a toxic range with systemic delivery [88].…”