1386

INTRAPROSTATIC INJECTION OF BOTULINUM TOXIN IN THE TREATMENT OF SYMPTOMATIC LUTS, INCLUDING SEQUENTIAL MRIS FOR ACCURATE CHANGES IN SIZE OF THE PROSTATE

Tuesday, May 24, 2005

Thayne R Larson*, Scottsdale, AZ; Christian Huidobro, Cristian Acevedo, Santiago,, Chile; Lance A Mynderse, Rochester, MN; Benjamin Larson, Scottsdale, AZ

INTRODUCTION AND OBJECTIVE: A simple office injection that effectively treats LUTS would be a valuable office treatment alternative to the expensive machines now used. Botulinum Toxin a neurotoxin that blocks cholinergic neurotransmission was tested in the treatment of LUTS. The injection is done transrectally under ultrasound guidance without any anesthesia in a procedure similar to prostate biopsy. A small 22 guage needle is placed through the rectal ultrasound probe for correct placement of the needle. The injection is then accomplished depositing the toxin in the base and mid prostatic area of the lateral lobes. Immediately after treatment the patient gets dressed and returns to full activity without the need of catheterization. Treatment time is usually less than 10 minutes and performed with patient lying on his left side.

METHODS: 40 total patients were treated in the following scheme. 10 patients were injected with 100 units (U) - ( 50U to each lobe) in an open label study to primarily assess safety. IPSS, flows, bother scores, and sequential ultrasounds were also measured. 30 patients were injected with 200U (100U to each lobe) in a 2:1 treated to sham double blind study. The primary objective is to measure the symptom score changes and secondarily to quantify flows, IPSS scores, bother scores, VAS scores and sexual function, also any change in size of the prostate. Sequential MRIs taken pretreatment, one month and three months post treatment are performed and volumes of the prostate measured. Therefore we can accurately determine any changes.

RESULTS: All patients reported a mean VAS score of 2.3/ 10.0. No patient required immediate catheterization. Only one patient in the 40 treated has gone into retention requiring short term catheterization. No patient has experienced incontinence of urine or stool, nor any other complication other than one patient with an epididymitis treated successfully with antibiotics. The blind of the 30 patient 2:1 treatment sham will be broken at 6 months.

CONCLUSIONS: Botulinum Toxin has the potential of being an important change in the way we treat LUTS in the office. The preliminary data will verify a potential for its use and the duration of effects will determine its value.

Session Info: Podium - Tuesday, May 24, 2005, 3:30 PM - 5:30 PM

1387

INTRAPROSTATIC BOTULIN TOXIN INJECTION IN PATIENTS WITH SEVERE BENIGN PROSTATIC HYPERPLASIA A MULTICENTER FEASIBILITY STUDY

Federico Guercini*, Antonella Giannantoni, Rome, Italy; Robert L Bard, New York, NY; Giuseppe Brisinda, Federica Cadeddu, Giorgio Maria, Paolo Rosi, Cinzia Pajoncini, Massimo Porena, Rome, Italy

INTRODUCTION AND OBJECTIVE: Botulinum toxin (BTX-A) blocks acetylcholine release at the neuromuscular junction and in autonomic neurons. In patients with voiding dysfunction, weakening of the urethral sphincter muscle by BTX-A injection is followed by symptoms improvement. BTX-A injection into the rat prostate induces selective denervation and subsequent atrophy. Recently, intraprostatic BTX-A has been reported to be efficacious in men with moderate voiding obstruction and medium sized prostates. Given this background, the present study was designed to determine the effects of BTX-A intraprostatic injection in patients with severe benign prostatic hyperplasia (BPH) and severe voiding obstruction.

METHODS: 16 patients were enrolled in the study. Inclusion criteria were prostatic volume >80cc and urinary peak flow ranging from 10 to 0 ml/sec (with indwelling catheters). The only exclusion criterion was presence of neurogenic bladder disorders. Patients underwent DRE, TRUS with uroflowetry and PSAt evaluation. Symptoms were assessed by the AUA -IPSS score. Each patient received a intraprostatic ultrasound-guided injection of 150 U of BTX-A in a saline solution into each lobe. Patients underwent the same baseline evaluations after 1, 2 and 6 months’ follow up. Data were analysed using the analysis of variance for repeated measures.

RESULTS: The mean age of patients was 68.8 years (range: 56-90). All patients had BPH except for one who had low grade adenocarcinoma (not considered in PSAt evaluation). At the beginning of the treatment 3 patients had indwelling catheters.

CONCLUSIONS: We consider intraprostatic BTX-A injection as a mutually exclusive alternative to surgery in high grade voiding dysfunction, for BPH or cancer, particularly in patients at risk.

Session Info: Podium - Tuesday, May 24, 2005, 3:30 PM - 5:30 PM

1425

ALTERED NOS ISOFORM ABUNDANCE AND DISTRIBUTION IN BB/WOR DIABETIC PROSTATE

Carol A Podlasek*, Cynthia L Meroz, Yi Tang, Kevin E McKenna, Kevin T McVary, Chicago, IL

INTRODUCTION AND OBJECTIVE: Patients with benign prostatic hyperplasia (BPH) commonly display severe lower urinary tract symptoms (LUTS). The severity of LUTS is significantly increased in males with both BPH and diabetes. The relationship between diabetes and BPH remains unclear however impaired neural innervation of the prostate is common in patients with diabetes. Nitric oxide is a neurotransmitter that plays a crucial role in establishing and maintaining innervation of many organs. Nitric oxide synthase (NOS) is the primary source of nitric oxide. The abundant distribution of NOS in accessory sex organs suggests a primary role for this regulatory protein in the autonomic innervation of the prostate. We propose that altered NOS signaling caused by interruption of prostate innervation in individuals with diabetes may lead to increased severity of LUTS. In this study NOS isoform interactions in the prostate were examined in a diabetic rat model of neuropathy in order to improve our understanding of the molecular mechanisms that regulate prostate innervation.

METHODS: NOS-I isoform abundance and distribution were measured in control and diabetic BB/WOR rat prostate by RT-PCR, in situ hybridization, and Western and immunohistochemical analyses. Morphological changes in the diabetic prostate were examined by Tunnel assay and electron microscopy.

RESULTS: NOS-III is the most abundant NOS isoform present in the rat prostate. NOS-I and NOS-III distribution were significantly decreased in the diabetic dorsal prostate. Altered NOS distribution accompanied a substantial increase in apoptosis. NOS-I protein abundance was significantly increased in diabetic ventral and lateral prostates. Abnormal cytosolic morphology and an over abundance of protein filled vacuoles were observed in the diabetic dorsal prostate.

CONCLUSIONS: To our knowledge this is the first report of differential altered NOS isoform distribution and abundance in the prostates of a diabetic rat model of neuropathy. Degradation of prostatic endothelium, possibly caused by disruption of prostate innervation, suggests a mechanism through which LUTS severity may be increased in patients with diabetes.

Session Info: Discussed Poster - Wednesday, May 25, 2005, 8:00 AM - 12:00 PM

Read BPH Selected Abstracts - Part 3

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