A double-blind, randomized, placebo-controlled pilot study to investigate the effects of finasteride combined with a biodegradable self-reinforced poly L-lactic acid spiral stent in patients with urinary retention caused by bladder outlet obstruction from benign prostatic hyperplasia.
OBJECTIVE
To assess whether patients in acute urinary retention from benign prostatic enlargement can be treated with a combined therapy comprising finasteride and a bioabsorbable self-reinforced poly L-lactic acid (SR-PLLA) urethral stent.


METHODS
Fifty-five patients in acute urinary retention were treated as outpatients; they had a suprapubic catheter inserted and the SR-PLLA stent placed cystoscopically. After 2 weeks the patients were randomized to receive either finasteride 5 mg daily or placebo. They were assessed at baseline and at 6, 12 and 18 months for maximum urinary flow rate, prostate volume and serum prostate-specific antigen (PSA).


RESULTS
Nineteen patients completed the study while 36 discontinued. There was a statistically significant increase in the mean maximum flow rate, and a statistically significant decrease in the prostatic volume and serum PSA in the finasteride group. The same number of patients discontinued in both groups; the major reason for discontinuation was insufficient therapeutic response.


CONCLUSIONS
The major problems were discontinuation of treatment because the response to therapy was insufficient, and uncontrolled breakdown of the spiral stent. To solve these problems, new configurations of bioabsorbable stents are needed.
Isotalo
T
T
Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland.
Talja
M
M
Hellström
P
P
Perttilä
I
I
Välimaa
T
T
Törmälä
P
P
Tammela
T L
TL
D020341:Absorbable Implants; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D018120:Finasteride / Q000627:therapeutic use*; D006801:Humans; D019344:Lactic Acid / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011091:Polyesters; D011108:Polymers / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications*; D015607:Stents; D016896:Treatment Outcome; D001748:Urinary Bladder Neck Obstruction / Q000209:etiology*; D016055:Urinary Retention / Q000188:drug therapy* / Q000209:etiology
D004791:Enzyme Inhibitors; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); D018120:Finasteride