Angelo Gousse, MD, Paholo Barboglio, MD, Brian Cohen, MD, and Dinorah Rodríguez, RN

Miller School of Medicine, University of Miami, FL

Introduction and Objective: Intradetrusor Botulinum toxin type A (BTX-A) injection has emerged as a novel therapeutic option for the treatment of idiopathic overactive bladder (I-OAB) refractory to oral antimuscarinic agents. We designed an IRB approved prospective trial to evaluate the improvement in urinary frequency (UF) and urge urinary incontinence (UUI) using voiding diaries (VD), urodynamic findings, validated symptomatic improvement, and quality of life in I-OAB patients submitted to a scheduled re-injection BTX-A protocol.

Methods: 34 Patients with I-OAB refractory to antimuscarinics were randomized to receive intradetrusor BTX-A (100 U or 150 U) as 10 U/ml /injection “trigone and dome sparing” (10-15 injections) with a 14 Fr. flexible cystoscopy. We used Botox ® for BTX-A, which was funded by Allergan. Prior to injection, the patients were evaluated by: history, physical examination, Urogenital Distress Inventory-6 (UDI6), multichannel videourodynamics (UDS), and urine culture. Repeat UDS were obtained at 6 weeks and prior every injection. The above mentioned questionnaires, 3 consecutive days VD, urinalysis, post-void residual volume were taken at every visit: 2wks, 6wks, 3mon and 6mon after every injection. Patients were re-injected using the same randomized dose and technique every 6 months regardless of response.

Results: Mean age was 56 years (22-80) at the beginning of the study. 29 Female and 5 male subjects were evaluated. 21 Patients had UUI (OAB-Wet) and 13 (OAB-Dry). Of the 34 patients who received baseline injection, 20 received a second injection, 12 a third injection, 8 a fourth injection, 5 a fifth injection and 3 a sixth injection. We analyzed the improvement in UF and UUI during the period of 6-12 weeks, comparing the outcome with the baseline status (T-test). The data was calculated from the voiding diaries and UDI-6. We took the answers from domains 1 and 2 from the UDI-6 in order to obtain the UF (UDI6-Q1) and UUI (UDI6-Q2) data. Patients who changed their baseline response from greatly or moderate to little or none after having received the BTX-A were correlated with (Spearman Correlation) the improvement on VD (Table 1-2).

Conclusions: There was a very strong correlation between VD and UDI6/Q1 on urinary frequency. The correlation was only strong after the first injection between VD and UDI6/Q2 on urge urinary incontinence. The improvement was greater in urge urinary incontinence than in urinary frequency when the outcome at 6-12 weeks was compared with baseline. VD correlated better with UDI-6 when evaluating UF rather than UUI.

UroToday.com Coverage of SUFU 2007

Please log-in or register in order to submit comments.

Powered by AkoComment!