Intraprostatic injection of alcohol gel for the treatment of benign prostatic hyperplasia: preliminary clinical results.
Benign prostatic hyperplasia (BPH) is one of the most common diseases ailing older men. Office-based procedures offer the advantage of being more effective than medications, while limiting the adverse effects, cost, and recovery of surgery. This study presents preliminary data on a new procedure that utilizes intraprostatic alcohol gel injection to ablate prostatic tissue. The purpose of this study is to evaluate the feasibility of using this gel as a treatment for BPH. A total of 65 patients with lower urinary tract symptoms (LUTS) due to BPH were treated with intraprostatic injections of alcohol gel. The gel is composed of 97% denatured alcohol and a patented polymer to cause viscosity. Three different methods of injection were utilized: transrectal (TR) injections (8), transurethral (TU) injections (36), and transperineal (TP) injections guided by biplaned ultrasound (21). Each method provided easy access to the center of the prostate, where a volume of gel, approximately 20-30% of the prostatic volume, was injected. Follow-up was based on changes in peak urinary flow (Qmax), IPSS scores, quality of life scores (QoL), adverse effects, and failures. Data are available at 3 and 12 months. The procedure was well tolerated with only local or no anesthesia in the TR and TP groups; the TU group received spinal anesthesia. All groups showed statistically significant (p < 0.0001) improvements in Qmax, IPSS, and QoL. The mean amount of gel injected was 8.05 ml, representing 21.56% of the prostatic volume. Qmax increased from a baseline mean of 8.50 to 12.01 ml/s at 3 months, and to 11.29 ml/s at 12 months. IPSS scores improved from a baseline mean of 21.12 to 10.00 at 3 months, and to 11.84 at 12 months. QoL scores were only available for 55 patients. QoL scores improved from a baseline of 3.93 to 1.98 at 3 months, and to 2.18 at 12 months. No extraprostatic injury or adverse effects were reported due to treatment. This preliminary study presents significant results showing that intraprostatic injection of alcohol gel could be an option for the treatment of BPH and LUTS. The viscosity of the gel allows for accurate imaging under ultrasound, no run back along the needle allowing for multiple methods of delivery, and the gel does not spread to extraprostatic tissue. This new technique could provide a simple and possibly less expensive clinic procedure for treating BPH, and warrants further study.
Larson
Benjamin T
BT
Institute of Medical Research, Scottsdale, Arizona, USA. larson.thayne@earthlink.net
Netto
Nelson
N
Huidobro
Christian
C
de Lima
Marcelo Lopez
ML
Matheus
Wagner
W
Acevedo
Cristian
C
Larson
Thayne R
TR
D000368:Aged; D000438:Alcohols / Q000008:administration & dosage / Q000494:pharmacology*; D000431:Ethanol / Q000737:chemistry / Q000494:pharmacology; D005782:Gels / Q000494:pharmacology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011108:Polymers / Q000737:chemistry; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology*; D011788:Quality of Life; D016896:Treatment Outcome; D014783:Viscosity
D000438:Alcohols; D005782:Gels; D011108:Polymers; D000431:Ethanol