Introduction

Pelvic organ prolapse (POP) affects up to 65% of women, particularly as they age. This condition, where pelvic organs descend into the vaginal canal, can significantly impact a woman’s quality of life. Traditional treatment options include both conservative measures and surgery. However, recent research highlights the potential benefits of self-management of vaginal pessaries, a conservative treatment option. The TOPSY trial compared self-management with clinic-based care for women using vaginal pessaries.

Understanding Pelvic Organ Prolapse

Pelvic organ prolapse occurs when the pelvic organs, such as the bladder, uterus, or rectum, descend from their usual position into the vaginal canal. Symptoms include a sensation of something “coming down” into the vaginal space, urinary and bowel issues, sexual dysfunction, and pain. As the population ages, the prevalence of prolapse is expected to rise, making effective management strategies crucial.

Traditional Treatment Approaches

Prolapse can be managed conservatively or surgically. Conservative treatments often involve the use of vaginal pessaries, mechanical devices inserted into the vaginal canal to support the pelvic organs. Pessaries are widely used, with two-thirds of women in the National Health Service (NHS) opting for this method initially. However, traditional clinic-based pessary care requires women to visit a clinic every six months for removal and replacement, which can be inconvenient.

The TOPSY Trial: A New Approach

The treatment of prolapse with self-care pessary (TOPSY) study aimed to assess the clinical and cost-effectiveness of pessary self-management compared to clinic-based care. The trial involved 340 women from 21 UK centres, randomly assigned to either self-management or clinic-based care. The primary outcome was prolapse-specific quality of life, measured using the Pelvic Floor Impact Questionnaire-7.

Key Findings:

1. Quality of Life: There was no significant difference in prolapse-specific quality of life between the self-management and clinic-based care groups.
2. Complications: Women in the self-management group reported fewer pessary-related complications than those in the clinic-based care group.
3. Cost-Effectiveness: Self-management was more cost-effective, with lower mean costs (£578 vs. £728). The willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained was £564 and a high probability of cost-effectiveness (80.8%).

Implementation and Training

For self-management to be effective, proper training and support are essential. The TOPSY trial provided women with a 30-minute teaching session, an information leaflet, a follow-up call, and access to a telephone helpline. Healthcare professionals also received training to ensure consistent and effective delivery of the intervention.

Future Research and Recommendations

While the TOPSY trial demonstrated the feasibility and benefits of self-management, further research is needed to:

1. Develop Sensitive Quality of Life Measures: Current measures may not fully capture the impact of self-management on women’s quality of life.
2. Assess Effectiveness Across Diverse Populations: Future trials should include a wider range of ethnic groups and women with different abilities.
3. Explore Follow-Up Strategies: Research should investigate whether follow-up can be initiated by women or if planned intervals are necessary.

Conclusion

The TOPSY trial provides robust evidence that self-management of vaginal pessaries is a viable alternative to clinic-based care. It offers women greater control, reduces complications, and is cost-effective. Healthcare professionals and policymakers should consider incorporating self-management into standard pessary care services, providing women with the training and support they need to manage their pelvic organ prolapse effectively.