The National Institute for Health and Clinical Excellence is examining intramural urethral bulking procedures for stress urinary incontinence in women and will publish guidance on their safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedures. The Advisory Committee has made provisional recommendations about intramural urethral bulking procedures for stress urinary incontinence in women.

This document summarises the procedures and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendations
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on these procedures. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedures in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 21 June 2005
Target date for publication of guidance: September 2005

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and short-term efficacy of intramural urethral bulking procedures for stress urinary incontinence is adequate to support the use of these procedures provided that normal arrangements are in place for clinical governance and for audit or research.

Publication of longer-term efficacy outcomes will be useful. Clinicians should submit data to the British Association of Urological Surgeons registry (available from www.baus.org.uk/HomePage/MenuPage.asp) or the British Society of Urogynaecologists registry (for further information contact BSUG@rcog.org.uk).

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.

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.

A number of bulking agents are currently available.

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 by conventional open surgery.

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 (see Appendix).

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 (see Appendix).

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overview of intramural urethral bulking procedures for stress urinary incontinence in women, August 2004

Available from: www.nice.org.uk/ip262overview