5 Safety

5 Safety

This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Urinary retention was reported in 6% (2/34), 10% (3/30), 20% (5/25), 22% (6/27), and 38% (6/16) of patients in 5 case series of 34, 30, 25, 27 and 16 patients respectively.

5.2 Intermittent haematuria was reported in 24% (6/25) of patients in the case series of 25 patients (all resolved by 6 months). Debris or haematuria was reported in 18% (6/34) of patients in the case series of 34 patients. Haematuria was reported in 15% (4/27) of patients at 30‑day follow‑up in the case series of 27 patients (all resolved by 90 days). Mild haematuria was reported in 31% (5/16) of patients in the case series of 16 patients (resolved spontaneously in all patients within 1 to 27 days).

5.3 Dysuria was reported in 3% (3/103), 4% (1/27), 15% (5/34), and 20% (5/25) of patients in the case series of 103, 27, 34, and 25 patients respectively. Painful micturition during 4‑week follow-up was reported in 13% (2/16) of patients in the case series of 16 patients.

5.4 Urinary tract infection was reported in 6% (1/16), 7% (2/27), and 15% (5/34) of patients in the case series of 16, 27, and 34 patients respectively.

5.5 Postoperative infection (cystitis, epididymo-orchitis, or other infection) was reported in 3% (3/103) of patients in a case series of 103 patients. Urosepsis was reported in 1 patient in the case series of 16 patients. The patient was admitted to hospital for 6 days and treated with intravenous antibiotics.

5.6 Epididymitis was reported in 7% (2/27) of patients in the case series of 27 patients. In 1 of the patients, epididymitis led to abscess formation, which was treated by simple orchiectomy. Epididymitis (grade 3) was reported in 1 patient in the case series of 30 patients.

5.7 Urgency and frequency (Common Terminology Criteria for Adverse Events [CTCAE] grade 2) were each reported in 13% (2/16) of patients in the case series of 16 patients. Transient urgency was reported in 4% (4/103) of patients in the case series of 103 patients. Transient incontinence was reported in 12% (12/103) of patients in the case series of 103 patients.

5.8 Dysejaculation was reported in 5% (5/103) of patients in the case series of 103 patients.

5.9 Urethral stricture (grade 3) was reported in 1 patient in the case series of 30 patients.

5.10 Recto-urethral fistula was reported in 1 patient in the case series of 103 patients.

5.11 A temporary reduction in potency (less than 9 months) was reported in 10% (10/103) of patients and complete reduction in potency (more than 3 years) in 2% (2/103) of patients in a case series of 103 patients.

5.12 Self-resolving tachycardia during the procedure was reported in 1 patient in the case series of 34 patients.

5.13 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not report any anecdotal adverse events. They considered that the following were theoretical adverse events: damage to the urethra, bladder, urethral sphincter and rectum.

  • National Institute for Health and Care Excellence (NICE)