A Simple Test of Pelvic Sensation
Research type
Research Study
Full title
Pelvic Sensorineuropathy: A comparison between quantitative sensory testing and a simple hand held device
IRAS ID
173962
Contact name
Charlotte Mahoney
Contact email
Sponsor organisation
Central Manchester University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
One in three women experience symptoms of prolapse in their lifetime. Studies have shown women with symptoms of prolapse have reduced sensation in the pelvis, called pelvic sensorineuropathy.
The test for female pelvic sensation uses specialised equipment which is large and expensive, and so unsuitable for use in the general gynaecology clinic. A simple device to test for female pelvic sensation could allow the general gynaecologist to screen for pelvic sensorineuropathy.
To date no study has linked sensory function in the vagina with a histological assessment of nerve fibres, therefore the study will also aim to address this question.
The study will test sensation using the Gold Standard for pelvic sensory testing using specialist equipment and compare this to a simple hand held vibration device. If the hand held vibration device proves to be a good test of impaired pelvic sensation in women, this could be explored by the manufacturers to increase the license and allow Doctors to screen for pelvic sensorineuropathy in women attending the Urogynaecology clinic. Women who choose to participate will undergo pelvic sensory testing with the gold standard specialised equipment and the simple hand-held screening tool.
The study will also correlate sensory function with what is happening to nerve fibres at a microscopic level. Women undergoing surgery for their prolapse will be invited to donate the excess vaginal mucosa. A small group of women without prolapse undergoing gynaecological surgery will also be invited to donate a sample of vaginal mucosa and undergo pelvic sensory testing for a control comparison. Nerve fibres in both groups will be examined using a range of histological techniques, and this will be correlated with sensory function.
The study will involve women attending the Urogynaecology department at St Mary’s Hospital. The study will last up to 12 months.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
16/NW/0715
Date of REC Opinion
30 Nov 2016
REC opinion
Further Information Favourable Opinion