Developing a Valsalvometer to detect pelvic floor muscle weakness

We are collaborating with healthcare professionals and Trustech in Manchester to explore routes to standardising the assessment of pelvic floor muscle weakness.

Project Lead and Organisation

Dr Alison Watson, Central Manchester University Hospitals NHS Foundation Trust

Clinical Requirement

Pelvic floor weakness and the resultant symptoms of urinary incontinence and pelvic organ prolapse are common.  Urinary incontinence generates a healthcare need in over a third of adults over the age of 40 years; the annual cost burden for urinary incontinence for the NHS is over £500m.  One in eleven women will require a surgical intervention for pelvic floor weakness by the age of 80 years and there are over 45,000 surgical procedures performed annually in England and Wales for stress incontinence of urine and pelvic organ prolapse.

Pelvic floor weakness can lead to prolapse. However, the clinical assessment of prolapse is hampered by a lack of standardisation. To assess pelvic floor weakness, the patient needs to generate raised intra-abdominal pressure, which causes the pelvic floor to distort and descend, which can then be quantified by the clinician. Different clinicians currently ask people to raise their intra-abdominal pressure in different ways, and patients may find it difficult or embarrassing to do this fully.

If the assessment of pelvic floor weakness could be accurately standardised there would be much greater validity in the assessment of the effectiveness of different interventions, both in individuals with different conditions, and in the same individuals in response to treatment over time.

The Solution

If people could raise their intra-abdominal pressure (IAP) to a standard level it would enable clinicians to assess the degree of pelvic floor distortion more easily. IAP can be measured using a pressure-sensitive rectal balloon, but this is an unwelcome invasive investigation. We are therefore exploring an alternative. We are investigating whether raising intrapulmonary pressure (IPP) by blowing into a tube correlates with raised IAP. This has required significant technical expertise in combination with specialist clinical knowledge. This correlation has been demonstrated in a small-scale trial with healthy individuals. If this correlation proves sufficiently robust in people with known pelvic floor muscle weakness we will seek further funding to develop a device designed with users to enable standard assessments of pelvic floor muscle weakness.

Impact

Pre- and post-operative clinical assessment of prolapse is being hampered by a lack of standardisation.  If the assessment of pelvic floor weakness could be accurately standardised there would be much greater validity in the assessment of the value of different interventions. This could lead to more appropriate use of existing treatments, and better outcomes for patients. It could also create an environment that provides greater opportunity for new treatments to be developed.

Men do not suffer from pelvic floor weaknesses to the same extent as women. They do however suffer from hernias of the abdominal wall. These are usually diagnosed by the patient being asked to cough, which raises the IAP causing the hernia to bulge out of the abdominal wall.  However, coughing is unlikely to produce a consistent and repeatable IAP. The development of a way to consistently and easily raise IAP has the potential to enable easier assessments of hernias in addition to pelvic floor weakness.

Partners

  • Central Manchester University Hospitals NHS Foundation Trust
  • Trustech
  • Devices for Dignity at Sheffield Teaching Hospitals NHS Foundation Trust

Image Attribution:

Image ‘Blowing Bubbles’ courtesy of Christos Loufopoulos. Image reproduced unaltered and licensed under CC BY 2.0. Source.