Jane Watkins

Repeated Botulinum Toxin Type A Injections for Refractory Overactive Bladder: Medium-Term Outcomes, Safety Profile, and Discontinuation Rates

BACKGROUND Efficacy and safety of botulinum toxin type A (BoNTA) injection is supported by level 1 evidence, but data regarding repeated injections are limited in patients with refractory overactive bladder (OAB) and idiopathic detrusor overactivity (IDO). OBJECTIVES Describe medium-term outcomes and discontinuation rates for patients adopting repeated BoNTA as a management strategy for IDO. DESIGN, SETTING, AND PARTICIPANTS Prospective data from a single centre were collected from the first 100 patients. INTERVENTION Bladder injection of BoNTA (predominantly 200 U onabotulinumtoxinA; Allergan Ltd., Marlow, Buckinghamshire, UK) in an outpatient setting. MEASUREMENTS OAB symptoms, quality of life, discontinuation rates, interinjection interval, and adverse events were recorded. Data comparisons were performed using a generalised linear model or a chi-square test where appropriate. RESULTS AND LIMITATIONS Two hundred seven injections were performed in 100 patients. All patients had 1 injection, 53 had a total of 2, 20 had 3, 13 had 4, 10 had 5, 5 had 6, 3 had 7, 1 had 8, 1 had 9, and 1 had 10 injections. Statistics were applied up to five repeated injections. A statistically significant reduction in frequency, urgency, and urge urinary incontinence were seen following the first BoNTA injection compared to baseline. This improvement was maintained after repeated injections and was not statistically different when comparing differences between injections. Thirty-seven patients stopped treatment after the first two injections; thereafter, dropouts were rare. The most common reasons for discontinuing treatment were poor efficacy (13%) and clean intermittent self-catheterisation (CISC)-related issues (11%). The incidence of CISC after the first injection was 35%. Bacteriuria was detected in 21% of patients. The mean interinjection interval was 322 d. Limitations included the concurrent use of antimuscarinic drugs in some patients. CONCLUSIONS BoNTA can provide a safe and effective medium-term management option for patients with refractory IDO. The most common reasons cited for stopping treatment were poor efficacy and CISC-related issues.

Voiding DysfunctionRepeated Botulinum Toxin Type A Injections for Refractory Overactive Bladder: Medium-Term Outcomes, Safety Profile, and Discontinuation Rates

BACKGROUND Efficacy and safety of botulinum toxin type A (BoNTA) injection is supported by level 1 evidence, but data regarding repeated injections are limited in patients with refractory overactive bladder (OAB) and idiopathic detrusor overactivity (IDO). OBJECTIVES Describe medium-term outcomes and discontinuation rates for patients adopting repeated BoNTA as a management strategy for IDO. DESIGN, SETTING, AND PARTICIPANTS Prospective data from a single centre were collected from the first 100 patients. INTERVENTION Bladder injection of BoNTA (predominantly 200 U onabotulinumtoxinA; Allergan Ltd., Marlow, Buckinghamshire, UK) in an outpatient setting. MEASUREMENTS OAB symptoms, quality of life, discontinuation rates, interinjection interval, and adverse events were recorded. Data comparisons were performed using a generalised linear model or a chi-square test where appropriate. RESULTS AND LIMITATIONS Two hundred seven injections were performed in 100 patients. All patients had 1 injection, 53 had a total of 2, 20 had 3, 13 had 4, 10 had 5, 5 had 6, 3 had 7, 1 had 8, 1 had 9, and 1 had 10 injections. Statistics were applied up to five repeated injections. A statistically significant reduction in frequency, urgency, and urge urinary incontinence were seen following the first BoNTA injection compared to baseline. This improvement was maintained after repeated injections and was not statistically different when comparing differences between injections. Thirty-seven patients stopped treatment after the first two injections; thereafter, dropouts were rare. The most common reasons for discontinuing treatment were poor efficacy (13%) and clean intermittent self-catheterisation (CISC)-related issues (11%). The incidence of CISC after the first injection was 35%. Bacteriuria was detected in 21% of patients. The mean interinjection interval was 322 d. Limitations included the concurrent use of antimuscarinic drugs in some patients. CONCLUSIONS BoNTA can provide a safe and effective medium-term management option for patients with refractory IDO. The most common reasons cited for stopping treatment were poor efficacy and CISC-related issues.

A Single-centre Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL)

BACKGROUND Laparoscopic radical cystectomy (LRC) and robot-assisted radical cystectomy (RARC) are increasingly popular, but high-level evidence for these techniques remains lacking. OBJECTIVE To compare the outcomes of patients undergoing open radical cystectomy (ORC), RARC, and LRC. DESIGN, SETTING, AND PARTICIPANTS From March 2009 to July 2012, 164 patients requiring radical cystectomy for muscle-invasive bladder cancer or high-risk non-muscle-invasive bladder cancer were invited to participate, with an aim of recruiting 47 patients into each arm. Overall, 93 were suitable for trial inclusion; 60 (65%) agreed and 33 (35%) declined. INTERVENTION ORC, RARC, or LRC with extracorporeal urinary diversion. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary end points were 30- and 90-d complication rates. Secondary end points were perioperative clinical, pathologic, and oncologic outcomes, and quality of life (QoL). The Fisher exact test and analysis of variance were used for statistical analyses. RESULTS AND LIMITATIONS The 30-d complication rates (classified by the Clavien-Dindo system) varied significantly between the three arms (ORC: 70%; RARC: 55%; LRC: 26%; p=0.024). ORC complication rates were significantly higher than LRC (p<0.01). The 90-d complication rates did not differ significantly between the three arms (ORC: 70%; RARC: 55%; LRC 32%; p=0.068). Mean operative time was significantly longer in RARC compared with ORC or LRC. ORC resulted in a slower return to oral solids than RARC or LRC. There were no significant differences in QoL measures. Major limitations are the small sample size and potential surgeon bias. CONCLUSIONS The 30-d complication rates varied by type of surgery and were significantly higher in the ORC arm than the LRC arm. There was no significant difference in 90-d Clavien-graded complication rates between the three arms. PATIENT SUMMARY We compared patients having open, robotic, or laparoscopic bladder removal surgery for bladder cancer and found no difference in Clavien-graded complication rates at 90 d.

Patient experience and satisfaction with Onabotulinumtoxin A for refractory overactive bladder

To evaluate the patient experience of our dedicated botulinum toxin A (BTX‐A) service using a validated patient‐reported experience measure (PREM) and assess patient‐reported satisfaction with treatment.

Validation of the bladder control self‐assessment questionnaire (B‐SAQ) in men

To validate the Bladder Control Self‐Assessment Questionnaire (B‐SAQ), a short screener to assess lower urinary tract symptoms (LUTS) and overactive bladder (OAB) in men.