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17211

Efficacy and Safety of Alfuzosin In the Reduction of Hydronephrosis In Patients with Neuropathic Bladder and Elevated Detrusor Leak Point Pressures

Saturday, October 20, 2012
Grand Ballroom A/B (Hilton Riverside)
Paul F. Austin, MD, FAAP, Pediatric Urology, Washington University School of Medicine, Saint Louis, MO, Barbara Wamil, MD, Sanofi_Aventis, Bridgewater, NJ and Israel Franco, MD, Urology, New York Medical College, Valhalla, NY

Purpose: Hydronephrosis (HN) is considered a surrogate marker for elevated bladder pressures in patients with neuropathic bladder and increases the risk for future renal damage if left unchecked.  Previous studies have shown that the detrusor leak point pressures (DLPP) can be lowered in these patients with alpha blocker therapy. We set out to ascertain if Alfuzosin can have a positive effect on the neuropathic bladder in patients with elevated DLPP by causing a significant reduction in the degree of hydronephrosis.  Additionally, we evaluated the safety and tolerability of Alfuzosin.

Methods: A prospective trial was conducted enrolling patients with neuropathic bladders with a LPP>40 cm H20 and SFU grade 1-3 HN.  The primary endpoint of the study was a decrease of at least 1 grade of hydronephrosis on 12-weeks of therapy. The patients were divided into 2 age groups: 2-7 yo (group 1) and 8-16 yo (group 2).  The 8-16 yo group was evenly divided into patients receiving liquid (group 2A) and tablet (group 2B) formulations. All patients received a 0.2mg/kg/day dose of Alfuzosin over a 12-week period.  Renal ultrasounds were performed at the onset and end of the study.  A blinded, central reader reviewed all ultrasonographic studies. A standard protocol reviewing any adverse events was conducted at each follow-up visit.

Results: A total of 25 patients (pts) were enrolled into the study (12 pts group 1, 13 pts group 2). There were 9 males and 16 females.  Mean age of the patients was 7.9 4 yo. One patient in the 2-7 yo age group dropped out.

Reduction of HN

HN location

Group 1 (%)

Group 2 (%)

Group 2A (%)

Group 2B (%)

Total (%)

Bilateral

2/12 (17)

8/13 (62)

5/6 (83)

3/7 (43)

10/25(40)

Left

5/12 (42)

11/13 (85)

6/6 (100)

5/7 (71)

16/25 (64)

Right

4/12 (33)

10/13 (77)

5/6 (83)

5/7 (71)

14/25 (56)

Twenty pts (80.0%) showed a response in at least one kidney, with 7 pts (58.3%) in group 1 and 13 pts (100.0%) in group 2. Six pts (24.0%) had complete resolution of bilateral HN, with 1 pt (8.3%) in group 1 and 5 pts (38.5%) in group 2. Four pts (16.0%) with unilateral Grade 3 HN at baseline had an improvement to Grade 0. Adverse events included 3 reports of dermatitis/rash, 1 event of tachycardia and 1 of dizziness. There were no serious adverse events.

Conclusion: Overall, Alfuzosin reduces hydronephrosis by at least one SFU grade in 80% of patients with unilateral HN and in 40% of patients with bilateral HN. There is good tolerability of Alfuzosin with no serious adverse events during this 12-week study. Long-term treatment studies are needed to determine if greater changes in the grade of HN are achievable with extended treatment.