Evidence Table 47What is the effectiveness of alpha-blockers in treating men after acute urinary retention?

Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Lucas et al., 2005176

Study design:
Randomised controlled study

Setting: 8 hospitals and one in Ireland.

Evidence level:
1+

Duration of follow-up:
3-8 days depending on normal practice of hospital.
Patient group: Men with acute urinary retention (AUR) secondary to benign prostatic hyperplasia recruited from March 1997 to December 2000 from an Accident and Emergency department..
Inclusion criteria: Men with acute urinary retention, who had been catheterised in the previous 72 hours.
Exclusion criteria: Men with initial catheterisation volumes of >1500mL or <500mL ; evidence of renal or hepatic dysfunction; previous surgery on the urinary tract; other diseases of the bladder; any malignancy; retention-enhancing medications; allergies; and sever cardiac disease.

All patients
N: 149
Mean age: 69.4 (range: 51-91) years
Drop outs: 8 not evaluable and not included in ITT analysis.

Group 1
N: 71
Mean (±SD) Age: NR
Dropouts: NR

Group 2
N: 70
Mean (±SD) Age: NR
Dropouts: NR
Group 1: Alpha-blocker
Tamsulosin hydrochloride 0.4mg in a modified-release capsule once daily. Medication given after breakfast or lunch on the first dose, then after each day's breakfast. Duration of treatment was decided by each site to be either three or 8 doses, according to their normal practice.

Group 2: placebo
Successful trial without catheter (defined as a flow rate of >5mL/s, >100mL voided volume, and a residual volume of≤200mL)Group1: 24/71 (34%)
Group 2: 17/70 (24%)
p value: 0.193
Funding: Sponsored by a grant from Yamanouchi Pharma Ltd.

Limitations:
None

Notes:
Definition of success in treatment of AUR has yet to be universally agreed. The initial definition was not significant but the authors conducted secondary analysis using revised criteria of success. This was completed before breaking randomisation code.

Some patients were catheterised for 3 day and others for 8; to allow for variations in practice across the sites. Differences in outcome between the two were not statistically significant.
Secondary analysis: (success defined as any of two free-flow criteria described above)Group1: 41/71 (58%)
Group 2: 28/70 (40%)
p value: 0.02
Secondary analysis: Success defined as flow rate >5mL/s, voided volume>100mLGroup1: 37/71 (52%)
Group 2: 24/70 (34%)
p value: 0.019
Secondary analysis: (defined as a flow rate of >5mL/s, >100mL voided volume, and a residual volume of≤250mL)Group1: 43/71 (61%)
Group 2: 29/70 (41%)
p value: 0.013
Patients not re-catheterisedGroup1: 34/71 (48%)
Group 2: 18/70 (26%)
p value: 0.011
OR: 2.47, 95% CI: 1.23-4.97
Patients re-catheterisedGroup1: 37/71 (52%)
Group 2: 52/70 (74%)
Adverse eventsDizziness
Group 1: 7/71 (10%)
Group 2: 2/70 (3%)
Somnolence
Group 1: 4/71 (6%)
Group 2: 2/70 (3%)
Mortality (carcinomatosis; not due to intervention)
Group 1: 1/71 (1%)
Group 2: 0/70 (0%)
Patients withdrew due to adverse eventsGroup 1: 7 (9%) Group 2: 1 (1%)
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
McNeill et al., 1999193

Study design:
Randomised controlled trial

Setting:
Scotland (4 centres)

Evidence level:
1+

Duration of follow-up:
Treatment for 48 hours. Follow-up of successful patients for mean 7.2 months
Patient group: patients with a first episode of acute urinary retention related to benign prostatic obstruction were recruited between September 1996 and March 1998 from 4 centres in Scotland.

Inclusion criteria: 55 years or over; residual volume of 0.5-1.5L on catheterisation.

Exclusion criteria: patients unwilling or unable to give informed consent; significant renal and/or hepatic disease; depressive illness on medication; extra-pyramidal disorders; neurological disease; confirmed or suspected urethral stricture; dipstick detected UTI, acute or chronic prostatitis. History of unstable angina pectoris, myocardial infarction, transient ischaemic attacks, cerebrovascular accident of congestive cardiac failure during the previous 6 months, current or previous orthostatic hypotension. Patient taking monoamine oxidase inhibitors, cholinergic or anticholinergic drugs, calcium-channel blockers, or alpha blocking drugs. Other antihypertensive drugs were not altered whilst the patient was receiving the trail medication. Phytotherapy or finasteride use did not exclude patients from study but their use was recorded. Known hypersensitivity to afluzosin or alpha blockers. Patients requiring suprapubic catheterisation where urethral catheterisation was unsuccessful; patients who had a suprapubic catheter as a primary procedure were not excluded. Postoperative retention after major abdominal/pelvic surgery. Large residual volume, clot retention secondary to haematuria of any cause.

All patients
N: 81

Group 1
N: 40
Mean (±SD) Age: 67.7 (13.6)
Dropouts: 1 (withdrew following a faint after the first dose of the trial medication)

Group 2
N: 41
Mean (±SD) Age: 72.7 (8.33)
Dropouts: 0
Group 1: alpha-blocker
Sustained-release alfuzosin, an alpha1-selective blocker, (5mg twice daily, with no dose titration) for 48 hours. Catheter removed after 24 hour of treatment and final dose was given on the afternoon after catheter removal.

Group 2: placebo
Identical procedure as intervention but with placebo (twice daily for 48 hours).
Number (%) of patients successful:
(defined as able to void successfully after removal of catheter and not re-catheterised within 24h)
Group1: 22/40 (55%)
Group 2: 12/41 (29%), P=0.034
Odds Ratio (OR): 2.95 (95% CI 1.08-8.21)
Funding: Financial support for the study was received from Lorex Synthelabo UK & Ireland; authors received financial support from Lorex Synthelabo to attend and present their work at scientific meetings.

Limitations:
The mean age was 5 years lower in the intervention group (significant difference).

Following power calculation the authors planned to recruit 100 per arm to detect a 20% difference in outcome with 95% power. Unable to reach this number before the trial medication expired. The difference in outcome between the groups was >20% and power of the study is reflected in statistical significance of the results.

Additional outcomes:
Comparison of variables between successful and unsuccessful patients. Non significant results for mean residual volume on catheterisation, mean duration of catheterisation and prostate size.

Additional follow-up of 11/34 (32%) successful patients experiencing a further episode of AUR and/or requiring a prostatectomy (mean follow-up of 7.2 months).

Notes:
Atrial fibrillation 8 hours after last dose, which was later resolved. A subsequent 24-h ECG revealed previously undiagnosed asymptomatic paroxysmal atrial trachycardia, which was treated with sotalol.
Number (%) of patient successful using per-protocol analysis
(excluding patient that withdrew and ailed to complete medication)
Group1: 22/39 (56%)
Group 2: 12/41 (29%), P=0.026
Odds Ratio (OR): 3.13 (95% CI 1.13-8.76)
Mean (SD) age for all patients:Successful: 68.4 (7.8)
Unsuccessful: 72.9 (8.1)
P=0.02
Mean (SD) age by success in each group:Group 1:
Successful: 69.1 (8.7)
Unsuccessful: 69.6 (7.3), p=0.81
Group 2:
Successful: 67.2 (6.1)
Unsuccessful: 75.0 (8.1), p=0.005
Logistic regression analysis of treatment versus outcome adjusted for ageP=0.052
OR: 2.55, 95% CI 0.99-6.58
Logistic regression using per-protocol analysis:P=0.039
OR: 2.72, 95% CI 1.05-7.08
All reported adverse eventsFaint:
Group 1: 1/40
Group 2: 0/41
Dizziness:
Group 1: 1/40
Group 2: 0/41
Headache:
Group 2: 1/40
Group 2: 0/41
Atrial fibrillation*
Group 1: 1/40
Group 2: 0/41
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
McNeill et al., 2004194

Study design:
Randomised controlled trial.

Setting: 71 centres across Europe and South Africa.

Evidence level:
1+

Duration of follow-up:
Treatment for 3 days.
Patient group: patients presenting with a first episode of spontaneous AUR related to BPH between January 2000 and March 2002.
Inclusion criteria: Minimum age of 51 yrs; urine retention volume 500-1500ml at catheterisation
Exclusion criteria: Patients with mental disorders, in a trial within last 3 months, patients with neurogenic bladder dysfunction, isolated bladder neck disease, prostatitis, carcinoma of prostate, history of prostatic and urethral surgery, urethral stricture, bladder stones, clot retention secondary to hematuria; residual volume <500ml or > 1500ml, AUR not related to BPH; Parkinson's disease, insulin dependent diabetes, multiple sclerosis, stroke or myocardial infarction within last 6 months, hepatic abnormalities, unstable or severe heart failure, history of postural hypotension or syncope, hypersensitivity to a-blockers, evolutive neoplastic disease; patients who received sympathomimetics within the previous week, received 5a-reductase inhibitors within previous 3 months or a-blocker in previous month, received tricyclic antidepressants, anticholinergics, sympathomimetics or first generation antihistamines within previous months, patients receiving disopyramide.
All patients: N: 363
Drop outs: 3 (results missing)

Group 1: N: 238
Mean (±SD) Age: 69.3 (8.5)
Dropouts: 4 (postural hypotension=2, catheter related infection=1 and treatment unrelated haemorrhoids=1)

Group 2: N: 122
Mean (±SD) Age: 69.4 (8.0)
Dropouts: 1 (catheter related infection)
All patients: urethral bladder catheterisation was performed. Catheter removed after minimum of two doses of study drug and each patient received one additional tablet the day after catheter removal.

Group 1: Alpha-blocker
10mg alfuzosin once daily for three days

Group 2: Placebo
Once daily for three days.
Success (defined as patient returned to satisfactory voiding within the first 24 hours following removal of the urethral catheter without re-catheterisation)Group1: 146/236 (61.9%)
Group 2: 58/121 (47.9%)
p value: 0.012
Funding: NR.

Limitations: Breakdown of adverse events not listed.

Additional outcomes:
Logistic regression analysis of successful trial without catheter. Age 65 years plus and drained volume 1000ml or greater adversely influenced the successful voiding rate.

Backward multiple logistic regression.

Notes:
Randomisation in a 2:1 ratio for intervention: placebo.

Extension study carried out following patients that had a successful trial without catheter.
Number of patients experiencing at least one adverse eventGroup1: 20/238 (8.4%)
Group 2: 16/122 (13.1%)
Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Shah et al., 2002272

Study design:
Randomised controlled trial

Setting: St Lukes Hospital and Bradford Royal infirmary, UK

Evidence level:
1+

Duration of follow-up:
2 weeks for primary study and follow up of successful patients at 2 years.
Patient group: patients presenting with acute urinary retention at the hospital between March 1998 and December 1999.

Exclusion criteria: patients with cardiac disease contra-indicating the use of alpha blockers, receiving medical therapy for bladder outflow obstruction, patients with bladder calculi, prostate cancer, renal impairment, urethral stricture, urinary infection, neurogenic bladder dysfunction, bladder tumour and clot retention.

All patients
N: 81
Mean age: 68.6 (46-88) years
Drop outs: 19 (urethral stricture=1, patient request for removal=9, adverse events=1, other reasons including suprapubic catheter, aortic aneurysm and other severe co-morbidity=8)

Group 1
N: 34
Mean (±SD) Age: 69.5 (56-88)
Dropouts: 0

Group 2
N: 28
Mean (±SD) Age: 67.7 (46-84)
Dropouts: 0
Group 1: Alpha-Blocker
Alfuzosin SR 5mg twice a day. Catheter removed after a minimum of three doses or 36 hours of admission.

Group 2: Placebo
Catheter removed after a minimum of three doses or 36 hours of admission.

All patients: if trial without catheter was unsuccessful a second trial was given 2 weeks later. During this period patients continued their trial medication. If unsuccessful again patients were offered alternative treatment options.
Successful voiding
(defined as being able to void with a residual volume of < 200ml)
Group1: 17/34 (50%)
Group 2: 16/28 (57%)
OR: 0.86 (95% CI: 0.38, 1.98; p=0.72)
Funding: Lorex Synthelabo Pharma

Limitations:
Method of randomisation and allocation concealment not reported. Baseline characteristics not addressed except for age.

Additional outcomes:
Additional outcomes for patients that had an unsuccessful trial without catheter and were given alfuzosin.

Notes:
The mean age and range at baseline was lower in the placebo group.
Unsuccessful voiding and re-catheterisedGroup 1: 17/34 (50%)
Group 2: 12/28 (43%)
TURP following successful trial without catheter (open labelled study where all patients on alfuzosin)Year 1: 13/30 (43%)
Year 2: 6/15 (40%)

From: Appendix D, Evidence Tables

Cover of The Management of Lower Urinary Tract Symptoms in Men
The Management of Lower Urinary Tract Symptoms in Men [Internet].
NICE Clinical Guidelines, No. 97.
National Clinical Guideline Centre (UK).
Copyright © 2010, National Clinical Guideline Centre.

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