A COMPARISON OF TRANSURETHRAL SURGERY WITH WATCHFUL WAITING FOR MODERATE SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA

John H. Wasson et al For The Veterans Affairs Cooperation Study Group on TURP NEJM 1995;332:75-9

Background
Symptoms compatible with the diagnosis of BPE are common Intractable retention or obstructive uropathy secondary to BPE are uncommon Patients with less advanced disease
Watchful waiting Medications Surgery

Material and methods

Multicentre, randomized trial comparing surgery with watchful waiting in patients with moderate symptoms of BPE

Selection of patients
Protocol approved by IRB at 9 participating centres July 1986 to July 1989 Written informed consent History taking, documentation of urinary symptoms, rectal examination, urinalysis, measurement of the serum creatinine, and ultrasonographic measurement of PVR. Intraop bladder trabaculations as per protocol

Material and Methods

Urinary symptoms rated on a scale of 0-27 on the basis of a nine question interview Uncertainty about treatment between 10-20 Correspond to moderate to severe symptoms on recent symptom indices

Exclusion Criteria
< 55 years H/O prostate surgery or radiation Unable to walk Active urinary tract infection not responding to treatment Diagnosis of prostate or bladder cancer PVR > 350 ml Low total score on a scale that rates benign prostatic hyperplasia on the basis of the findings of cystoscopy, the symptom interview, and bladder ultrasonography.

Exclusion Criteria
Severe comorbidities
uncontrolled diabetes, neurogenic bladder, cirrhosis, active alcoholism, bleeding diathesis, psychosis, and late-stage cardiac or respiratory disease

S. Creat > 3 mg/dL or double in previous year

Assignment to treatment
Randomly assigned to TURP or watchful waiting Surgery within 2 weeks of randomization 6-8 weeks after randomization and twice a year for 3 years Advice to limit coffee, alcohol and other liquids after dinner Avoid medications that might worsen symptoms

Followup
Peak flow , voided volume PVR Quality of life on a 100 point scale Interference in daily activities, sexual function, social activities and general well being

Statistical analysis
Primary Outcome measure : Treatment failure
Death Repeated or intractable urinary retention A residual urinary volume over 350 ml The development of a bladder calculus New, persistent incontinence requiring the use of a pad, penile clamp, or condom A symptom score of 24 or higher at one visit or scores of 21 or higher at two consecutive visits Doubling of the base-line serum creatinine

Treatment Outcomes
Urinary symptom score (considered lower if 14 and higher if 14) Degree to which urinary symptoms were bothersome (less bothersome if 55 and more bothersome if 55), Residual urinary volume (lower if 100 ml and higher if 100 ml) Voided Volume (lower if 150 ml and higher if 150 ml) Bladder trabeculation (none or mild vs. moderate or severe) Peak urinary-flow rate (lower if 10 ml per second and higher if 10 ml per second) Age (younger if 65 years and older if 65 years)

Statistical Analysis
Fishers exact test Chi square test T test P value </= 0.05 was significant SAS software

RESULTS
800 men screened Excluded
100 because of minimal findings 10 because of high PVR (350 mL) 4 because of markedly elevated symptom score 95 for other reasons 30 did not consent 5 were wrongly assigned to a treatment group

Results
556 men
280 surgery 276 watchful waiting

Patient characteristics
Mean age : 66+/-5 years Mean PVR : 111+/-76 mL S. creat : 1.3+/-0.27 Peak flow rate : 12+/-7mL/sec 57% had moderate to severe trabaculations Most bothersome symptom was nocturia>dribbling>urgency>hesitancy

Postoperative events
249 had TURP Complete information in 242 In 97% prostate was resected to the capsule Median weight : 14 g 78% had a hospital stay of </= 4 days 91% had no complication within 1st 30 days Need for catheter (4%) > perforation of capsule (2%) > hemorrhage requiring transfusion (1%)

Postop events
2 had UTI 1 had thrombophlebitis No deaths Prostate cancer in 10%

Postop events
Within 3 years
9 had bladder neck contracture 9 had urethral stricture 8 underwent repeat resection

Treatment outcome after 3 years

41 withdrew consent (24+17) 30 were lost to follow up (14+16)