Interventional procedures consultation document - retrograde urethral sphincterometry

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Retrograde urethral sphincterometry (RUS)

The National Institute for Health and Clinical Excellence is examining retrograde urethral sphincterometry (RUS) and will publish guidance on its 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 procedure. The Advisory Committee has made provisional recommendations about retrograde urethral sphincterometry (RUS).
This document summarises the procedure 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 this procedure. 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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 31 January 2006
Target date for publication of guidance: April 2006

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

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

1	Provisional recommendations

1.1	Current evidence suggests that there are no major safety concerns associated with retrograde urethral sphincterometry. However, there is a lack of evidence on the diagnostic utility of this procedure (that is, the extent to which knowledge of its results improves patients' outcomes) and it should be performed only in the context of good-quality research.

2	The procedure

*2.1*	*Indications*

2.1.1	Stress urinary incontinence is the involuntary leakage of urine during exercise or certain movements such as coughing, sneezing and laughing. It is usually due to weak or damaged muscles and connective tissues in the pelvic floor and urethral sphincter.
2.1.2	Diagnosis of stress urinary incontinence is usually based on symptoms, examination and exclusion of underlying causes or comorbidity.
2.1.3	Retrograde urethral sphincterometry (RUS) measures the pressure needed to open, and just keep open, a closed urethra by the retrograde infusion of fluid. This has been proposed as an assessment of urethral function in women with symptoms of stress urinary incontinence.
2.1.4	Established tests of urethral function include urethral pressure profilometry (UPP) and Valsalva leak point pressure. Radiographic assessment of urethral function can be done using videocystourethrography.


*2.2*	*Outline of the procedure*

2.2.1	Retrograde urethral sphincterometry involves placing a cone-shaped device a short distance (about 5 mm) into the external urethral meatus. The device then infuses fluid at a controlled rate into the urethra. The pressure required to open the urethral sphincter is displayed on the device.


*2.3*	*Efficacy*

2.3.1	Preliminary data on the use of this procedure in women with stress urinary incontinence found that there was a weak relationship between the results of this test and other standard tests. In a trial of 258 symptomatic women the mean retrograde urethral pressure as measured by RUS was 71 cm H2O and the mean values were reported as decreasing with increasing symptom severity. In another study, the mean retrograde urethral pressure was found to be 112.6 cm H2O in 61 asymptomatic women.
2.3.2	The impact of this procedure on patient outcomes is currently unclear. For more details, refer to the sources of evidence (see Appendix).

2.3.3	The Specialist Advisors noted that efficacy outcomes are yet to be established.


*2.4*	*Safety*

2.4.1	In a study of 258 women, pain (2%) and dysuria (2%) were the two most commonly reported complaints. A total of 12 adverse events were noted in a study of 61 asymptomatic women who had RUS; these included lower back pain (2%), discomfort (2%), urethral pain (3%), dysuria (3%), urinary urgency (3%), urinary frequency (3%) and transient incontinence (3%). For more details refer to the sources of evidence (see Appendix).

2.4.2	The Specialist Advisors noted urinary tract infection and mild discomfort as potential adverse events.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
January 2006

Appendix:

Sources of evidence

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

Interventional procedure overview of retrograde urethral sphincterometry, April 2005

Available from: www.nice.org.uk/ip296overview

This page was last updated: 30 March 2010