2 The procedure

2.1 Indications

2.1.1 Stress urinary incontinence is the involuntary leakage of urine during exercise or movements such as coughing, sneezing and laughing. It is usually caused by weak or damaged muscles and connective tissues of the pelvic floor, or by weakness of the urethral sphincter itself. It is estimated that 10–52% of adult women have some form of incontinence.

2.1.2 Typically, first-line treatment is conservative and includes pelvic floor muscle training, electrical stimulation and biofeedback. If the condition does not improve, surgical alternatives in women may include colposuspension, tension-free vaginal tape, transobturator foramen procedures or traditional suburethral slings.

2.2 Outline of the procedure

2.2.1 Intramural urethral bulking aims to augment the urethral wall and increase the urethral closure force. Several millilitres of bulking agent are injected into the submucosa of the proximal urethra just distal to the bladder neck. The injections are usually administered under local anaesthesia, either transurethrally or para-urethrally. Injections are undertaken either under vision using a cytoscope; or blindly, using a non-endoscopic implantation device.

2.2.2 A number of bulking agents are currently available.

2.3 Efficacy

2.3.1 A small randomised controlled trial reported that 53% (34/64) of patients treated by urethral bulking with collagen had no incontinence at 12 months, compared with 72% (39/54) treated with conventional open surgery.

2.3.2 One case series of patients treated with collagen reported that, after 12 months, 42% (38/90) had either no incontinence or an improvement in symptoms, as measured objectively using cystometry and abdominal leak point pressure. One case series of patients treated with silicone particles reported that 68% (69/102) had either no incontinence or marked improvement after a mean follow-up of 3 months. This proportion decreased to 48% (40/84) after a mean follow-up of 18 months. Four randomised controlled trials reported no difference in efficacy between different bulking agents. For more details, refer to the Sources of evidence.

2.3.3 The Specialist Advisors noted that efficacy may depend on patient selection, the bulking agent used and the injection technique.

2.4 Safety

2.4.1 Five case series reported safety data on a total of 389 patients. The most commonly reported adverse events were urinary tract infection, affecting 1% (1/102) to 12% (11/90) of patients, and urinary retention, affecting 0% (0/40) to 11% (10/90) of patients. Other reported complications included abscess at the injection site, urgency of micturition and prolonged pain. For more details, refer to the Sources of evidence.

2.4.2 The Specialist Advisors stated that migration of the bulking agent, voiding difficulties, urinary tract infection and allergic reaction are potential adverse events. Haemorrhage was listed as a rare potential adverse event.

2.5 Other comments

2.5.1 The Committee noted that a variety of bulking agents may be used for these procedures which may have different risk and benefit profiles.

2.5.2 The Committee particularly noted that the benefits of these procedures diminish with time but that the procedure can be repeated.