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BPH, haematuria, and finasteride

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Randomised studies
Observational studies
Comment

A question asked of Bandolier has been whether treating haematuria associated with benign prostatic hyperplasia (BPH) with finasteride works or is worthwhile. This has not been easy to answer because there have been few randomised trials, and few observational studies that address the topic. But recent months have seen some new studies that now allow a sensible look at the evidence.

Search


We searched PubMed, the Cochrane Library and reference lists up to February 2003 for any studies relating to haematuria (or hematuria), BPH, and finasteride. For the purposes of this brief review studies of any architecture were permitted, though randomised trials were preferred. All studies whose abstracts appeared to be relevant were obtained and read. Outcomes sought were recurrence of haematuria, any prostate surgery, and adverse events.

Results


There were three randomised trials and seven prospective or retrospective observational studies. Three observational studies related to a similar patient set, and the one with the most useful information was used to avoid duplication. Details of the eight studies included are in Table 1. The dose of finasteride, where stated, was 5 mg a day.

Table 1: Finasteride for haematuria in BPH - randomised and observational studies

Reference

Design

Included men

Outcome

Results

Foley et al. J Urol 2000 163: 496-498 Randomised, open study of 57 men with watchful waiting or finasteride 5 mg for 12 months Clinically documented BPH presenting with gross haematuria with no other cause. Average age 78 years, some with previous surgery Bleeding episodes, with severity Over 12 months:
watchful waiting: 17/29, 7 minor, 6 moderate, 4 severe
finasteride: 4/28, 3 minor, 1 moderate
7 hospital admissions in controls, 4 TURP, 3 cystoscopy
Delakas et al. Urol Int 2001 67: 69-72 Randomised, open study with 50 men treated with 5 mg finasteride daily for 4 years, and 30 controls (watchful waiting). Clinically documented BPH (after TURP in 17). At least 4 episodes of haematuria, mean age 74 years Recurrence of haematuria and surgery At 48 months:
control:
recurrence 23/30
TURP 9/30
finasteride:
recurrence 6/50
TURP 4/50
Perimenis et al. Urology 2002 59: 373-377 Randomised, open study of 42 men with watchful waiting, finasteride 5 mg, or cyproterone acetate 100 mg (daily doses) for 12 months Clinically documented BPH presenting with gross haematuria with no other cause. Average age 77 years, Bleeding episodes, with severity Over 12 months:
watchful waiting: 8/14, 2 minor, 2 moderate, 4 severe (2 TURP)
finasteride: 4/14, 2 minor, 2 moderate (0 TURP)
CYA: 3/14, 2 minor 1 moderate (0 TURP)
No adverse event discontinuations, and some impotence with CYA
Carlin et al. Prostate 1997 31: 180-182 Prospective observational study of 12 men treated with 5 mg finasteride daily for 6 months Gross haematuria secondary to BPH, excluding other causes Bleeding Bleeding subsided in 2 weeks in all patients, with no recurrences over mean of 11 months
Kashif et al. Prostate Cancer & Prostatic Diseases 1998 1: 154-156. Retrospective review of 42 men at haematuria clinic Bleeding associated with BPH and no other cause, 52-89 years, some with previous surgery Recurrence of haematuria and surgery No treatment, 6-18 months:
6/18 2 or more episodes
10/18 no episodes
3 TURP
Finasteride, 4-21 months
0/24 2 or more episodes
22/24 no episodes
0/24 TURP
two patients with minor adverse events with finasteride
Sieber et al. J Urol 1998 159: 1232-1233 Retrospective review of 42 men treated with finasteride at haematuria clinic Bleeding associated with BPH and no other cause, average age 74 years, some with previous surgery Recurrence of haematuria Over 6-40 months in 28 evaluable patients:
2/28 minor bleeds
1/28 severe bleeds
25/28 no bleeds
Miller & Puchner. Urology 1998 51: 237-240 Retrospective review of 28 men treated with finasteride for haematuria Bleeding associated with BPH and no other cause, age 62-87 years, some with previous surgery, some on aspirin or warfarin Recurrence of haematuria Over4-47 months:
5/28 minor bleeds
2/28 moderate bleeds
1/28 severe bleeds (intermittent use)
18/28 no bleeds
2 discontinued treatment
Redorta et al. Arch Esp Urol 2002 55: 895-899 Prospective observational study of 29 men treated with 5 mg finasteride daily for an average of 15 months Haematuria from BPH, mean age 71 years, many with previous prostate surgery Recurrence of haematuria, and surgery 25/29 no recurrence
0/29 TURP

Men in the studies were elderly, with mean ages in the 70s, and all had BPH with clear exclusion of any other cause of their haematuria, including PSA or biopsy for cancer.

Randomised studies


The three randomised studies were small and open, and none gave details of randomisation or concealment. Quality scores were 2 out of a possible 5 on a commonly used scale, indicating the possibility of bias. The largest study was conducted over 48 months, and the others over 12 months. The control was no treatment or watchful waiting.

Recurrence of haematuria to any degree occurred in 14/92 (15%) men on finasteride compared with 48/73 (66%) with no treatment (Figure 1). The risk of recurrence of haematuria was reduced by 75% with finasteride (Table 2), and the number needed to treat (NNT) was 2 (1.6 to 2.7) to prevent recurrence. Two studies noted the severity of recurrent haematuria, and it was mostly a single episode of bleeding and of minor severity.

Figure 1: Recurrence of haematuria with finasteride and placebo



Table 2: Outcomes in randomised studies, preventing recurrence of haematuria and TURP


Percent

Outcome

with finasteride

without finasteride

Relative risk
(95%CI)

NNT
(95%CI)

Prevent recurrence of haematuria 15 66 0.24 (0.15 to 0.40) 2.0 (1.6 to 2.7)
Prevent TURP 5 22 0.22 (0.08 to 0.58) 6.1 (3.7 to 17)

The necessity for prostate surgery (almost always transurethral prostatectomy) was reduced with finasteride, occurring in 5/92 (5%) of men on finasteride and 16/73 (22%) with no treatment. The risk of prostate surgery was reduced by 78% with finasteride (Table 2), and the number needed to treat (NNT) was 6 (3.7 to 17) to prevent surgery. In one study three other men having no treatment required hospital admission for cystoscopy.

Observational studies


The five observational studies examined cohorts of men with haematuria and BPH for various times, and reported the recurrence of haematuria (Table 1). The inclusion criteria were similar to men in the randomised trials.

Finasteride was given to 120 men, and 19 (16%) of those had recurrence of haematuria. In some, recurrence was associated with intermittent use of finasteride. No TURP surgery was reported in 53 men in two reports.

Comment


The amount and quality of information is neither large nor convincing, yet the results are consistent. Both randomised and observational studies yielded recurrence rates of 15% or 16% with finasteride, much less than was seen with no treatment in the randomised trials. NNTs were low. For every two men with BPH and haematuria with no other cause treated with finasteride one recurrence would be prevented, and for every six men one TURP avoided.

Treating a man with finasteride for a year is not cheap, at about £300. But recurrence has costs of possible cystoscopy, and prostatectomy has both costs and clinical problems in men in their late 70s. Formal cost-benefit analysis may be premature, but this certainly looks like an effective treatment in this particular group of men.
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