2 The procedure

2.1 Indications and current treatments

2.1.1 Benign prostatic obstruction occurs when the prostate enlarges, pressing against the urethra and the outlet from the bladder. Symptoms include a poor urine stream, urinary frequency, urgency, leaking or dribbling, and urinary retention.

2.1.2 Mild symptoms can be treated by medical therapy to relax the smooth muscle of the prostate and bladder neck, reduce prostate size or prevent further enlargement. When medical therapy is inadequate, patients may be treated surgically, usually by transurethral prostatectomy. If the prostate is very large, open prostatectomy (Millin's operation) or transurethral holmium laser prostatectomy may be considered; laparoscopic prostatectomy is a possible alternative for these patients.

2.2 Outline of the procedure

2.2.1 Laparoscopic prostatectomy is performed with the patient under general anaesthesia, using either a transperitoneal or an extraperitoneal approach, with or without computer (robotic) assistance. Incisions are made in the lower abdomen to provide access for the laparoscope and surgical instruments. A transverse incision is made on the anterior wall of the prostate capsule. If a transvesical approach is used, an incision is made in the bladder neck to expose the prostate. The glandular tissue of the prostate is freed from the prostate capsule and removed through the umbilical port incision. A catheter is inserted and the prostate capsule is closed with sutures.

Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

2.3 Efficacy

2.3.1 A non-randomised comparative study of 20 patients treated by laparoscopic prostatectomy and 20 patients treated by open prostatectomy reported similar mean postoperative International Prostate Symptom Score (IPSS) scores in the two groups, of 10 and 6.7, respectively (p = 0.5) (preoperative scores 20.9 and 17.8, respectively; p = 0.3) (IPSS scores, 0–35 scale from mild to severe symptoms).

2.3.2 The same study of 40 patients reported no significant difference between the mean postoperative maximum urine flow rates of 27.2 ml/s and 25.4 ml/s in the laparoscopic and open surgery groups, respectively (p = 0.5) (8.8 ml/s and 7.7 ml/s preoperatively; p = 0.4).

2.3.3 Four case series of 100, 60, 17 and 7 patients reported mean postoperative IPSS scores of 3.0, 5.2, 9.9 and 7.2 (24.2, 28.3, 24.5 and 22 preoperatively).

2.3.4 The Specialist Advisers considered key efficacy outcomes to include reduced blood loss, shorter hospital stay, improved postoperative urine flow rate and relief of urinary symptoms.

2.4 Safety

2.4.1 Two non-randomised comparative studies of 60 and 40 patients reported significantly less mean blood loss with the laparoscopic approach compared with open prostatectomy – 367 ml versus 643 ml (p = 0.04) and 412 ml versus 688 ml (p = 0.004).

2.4.2 The non-randomised comparative study of 60 patients and two case series of 17 and 7 patients reported that blood transfusions were required in 3% (1/30), 29% (5/17) and 14% (1/7) of patients. The non-randomised comparative study of 40 patients reported bleeding requiring re-operation in 5% (1/20) of patients. The case series of 17 patients reported haemorrhage (not otherwise specified) in 6% (1/17) of patients.

2.4.3 Two case series of 100 and 60 patients reported urinary infection in 2% (2/100) and 5% (3/60) of patients, respectively; there was one case of septicaemia. The non-randomised comparative study of 60 patients reported port-site infection in 3% (1/30) of patients.

2.4.4 Three case series of 60, 18 and 17 patients each reported 1 patient with clot retention. The comparative study of 40 patients and case series of 18 patients reported urethral stricture in 5% (1/20) and 6% (1/18) of patients. The non-randomised comparative study of 60 patients reported bladder stenosis in 3% (1/30) of patients. The case series of 60 patients reported retrograde ejaculation in 68% (41/60) of patients at 6-month follow-up.

2.4.5 The Specialist Advisers considered theoretical adverse events to include bleeding, rectal injury, bladder neck stenosis, urinary incontinence, leakage of urine from the bladder and damage to ureteric orifices.