Measuring changes in vaginal pressure pre and post prolapse surgery
Research type
Research Study
Full title
An observational pilot study to evaluate changes in intra-vaginal pressure profiles following Pelvic Organ Prolapse (POP) surgery using novel intra-vaginal pressure sensing device (IVPSD).
IRAS ID
243881
Contact name
Swati Jha
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
This is an observational pilot study in which we will be measuring the vaginal pressures of pelvic floor muscles before and after surgery for pelvic organ prolapse (POP) using a novel intravaginal pressure array sensor device (IVPSD).
Pelvic floor muscle weakness, often caused from childbirth, can lead to pelvic organ(s) descending or prolapsing into the vagina, as well as urinary incontinence (UI). This is a very important womens’ health issue with 25% of
women having symptoms associated with POP/UI.A team in Auckland University has developed an IVPSD to measure the pressures exerted on the vaginal wall by surrounding pelvic floor muscles and organs and to detect changes in vaginal pressure during pelvic floor muscle contraction. The IVPSD is a slim and flexible device that conforms to the vaginal anatomy without introducing a pressure itself. It has a much smaller diameter than a gynaecological speculum. Pressure profiles will be measured preoperatively and at 12 weeks post surgery using the IVPSD in thirty consenting women undergoing elective POP surgery in Jessop Wing, Royal Hallamshire Hospital, Sheffield. The symptoms and experience of vaginal prolapse for women will be measured using validated questionnaires at the same two time points.
By measuring vaginal pressures for women before and after POP surgery, we can understand more about how surgery restores the pelvic floor anatomy (structure) and whether there is improved pelvic floor muscle strength (function) following POP surgery. We will be evaluating the associations between measured vaginal pressures and patient symptoms/experiences determined from questionnaires before and after POP surgery.
Overall aim is to give both women and researchers more information on the impact of POP surgery on the structure and function of the pelvic floor.This is a novel concept and it is anticipated that this new information will be clinically valuable for longer term strategies to prevent and treat POP.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
19/EM/0006
Date of REC Opinion
2 Feb 2019
REC opinion
Further Information Favourable Opinion