Providing high-quality evidence to guide prolapse care pathways

Funded by prestigious grants from the Chief Scientist Office and Wellbeing of Women, two award-winning landmark randomised controlled trials (RCT) have demonstrated that Pelvic Floor Muscle Training (PFMT) is both clinically effective and cost effective for the prevention and treatment of pelvic organ prolapse. The resultant Lancet publications in 2014¹ and 2017² have become primary references for guiding prolapse care.

Two-thirds of women affected by pelvic organ prolapse will choose a vaginal support pessary to treat their symptoms which is usually fitted at a gynaecological clinic and the women return every six months to have it removed and changed. The TOPSY trial³- Treatment of Prolapse with Self-care pessary - is a large multi-centre RCT funded by the NIHR HTA, investigating whether women can remove, clean and reinsert the pessary themselves at home, empowering women to manage their own prolapse treatment and care. It will assess whether this method of self-management is more effective at improving women’s quality of life in comparison to standard follow-up care.

The annual incidence of surgery for pelvic organ prolapse is within the range of 15–49 cases per 10,000 women-years, and it is likely to double in the next 30 years. The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy. Existing trials of these augmentations are individually too small to be conclusive. The aim of the PROSPECT trial⁴, again funded by the prestigious UK NIHR HTA, was to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against standard repair in women. This study has demonstrated that in women having primary repairs, there was no evidence of benefit from the use of mesh inlay or biological graft compared to standard repair in terms of efficacy and quality of life in the short term.

Enabling healthcare professionals and policymakers to improve prolapse care pathways for patients globally

Two decades ago, evidence of the effectiveness of PFMT was scarce and national guidance did not exist. In addition, there was a lack of a brief, reliable measure of prolapse symptoms. Professor Hagen has worked closely with healthcare professionals, in particular pelvic floor physiotherapists, to develop and validate a tool to measure and monitor prolapse symptoms known as the Pelvic Organ Prolapse Symptom Score⁵ (POP-SS). Through a global survey of healthcare professionals involved in the management of prolapse, the team evaluated the impact in a real-world setting of using the POP-SS. A physiotherapist from Nepal said: "It helped in assessing the symptoms of pelvic organ prolapse and helps in monitoring change in symptoms after interventions."

Furthermore, work with policymakers within healthcare systems and the Scottish Government has led to improvements in national and international guidelines related to prolapse and this work is leading to a step-change in how PFMT is delivered to women.

Summary of the impact

• GCU-led research has led to the development of guidelines recommending that PFMT is the first-line treatment for prolapse and has been incorporated into the International Consultation on Incontinence reviews in 2013 and 2017. This publication serves as a key reference point for any healthcare professional involved in pelvic organ prolapse care.
• PFMT has been adopted by NICE guidelines in 2019 and incorporated within the guidelines of a number of European Gynaecology and Obstetrics Societies which should lead to improvements in prolapse for women offered treatment.
• Professor Hagen has contributed to Scottish Government enquiries related to transvaginal implants in prolapse surgery, leading to recommendations for a scoping review of physiotherapy capacity to improve the provision of prolapse healthcare for women.
• The Pelvic Organ Prolapse Symptom Score has received international recognition and been applied in healthcare and research settings globally in countries such as Ethiopia, India, Brazil, Nepal and Turkey and has been translated into Amharic, Turkish, Nepalese, Chinese, Russian and Samoan.
• GCU research has recently contributed to the development of the first UK Clinical Pessary Guidelines for pelvic organ prolapse management published in March 2021 which supports the NICE recommendation that a pessary should be considered as a non-surgical option for symptomatic prolapse with low-risk complications.
• The PROSPECT trial has recently been incorporated into NICE Guidelines in 2019 and provided economic evidence of surgical management of prolapse which was directly applicable to the NICE decision making context. This trial also contributed to the conclusions and recommendations contained within the final report of the Scottish Independent Review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women, leading to the recommendation not to offer transvaginal mesh procedures routinely and to seek other appropriate treatments where possible.

References

1. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial
2. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial
3. Does self-management of vaginal pessaries improve care for women with pelvic organ prolapse?
4. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT)
5. Psychometric properties of the pelvic organ prolapse symptom score