Treatment of prolapse with self-care pessary: the TOPSY trial

Conditions

Pelvic organ prolapse Urological and Genital Diseases

Bugge C, Dembinsky M, Khunda A, Graham M, Kearney R, Goodman K, Melone L, Guerrero K, Dwyer L, Hagen S, TOPSY team.

2025-12-05

Four Year Clinical and Cost Effectiveness of Vaginal Pessary Self‐Management Versus Clinic‐Based Care for Pelvic Organ Prolapse (<scp>TOPSY</scp>): Long Term Follow‐Up of a Randomised Controlled Superiority Trial

Carol Bugge, Rohna Kearney, Catherine Best, Kirsteen Goodman, Sarkis Manoukian et al. (23 authors)

BJOG An International Journal of Obstetrics & Gynaecology2025-08-201 citations

10.1111/1471-0528.18333

Clinical and cost‐effectiveness of pessary self‐management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation

Carol Bugge, Suzanne Hagen, Andrew Elders, Helen Mason, Kirsteen Goodman et al. (23 authors)

Health Technology Assessment2024-05-012 citations

10.3310/nwtb5403

Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial.

Hagen S, Kearney R, Goodman K, Best C, Elders A, Melone L, Dwyer L, Dembinsky M, Graham M, Agur W, Breeman S, Culverhouse J, Forrest A, Forrest M, Guerrero K, Hemming C, Khunda A, Manoukian S, Mason H, McClurg D, Norrie J, Thakar R, Bugge C.

2023-11-2310 citations

10.1016/j.eclinm.2023.102326

Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse

Lucy Dwyer, Carol Bugge, Suzanne Hagen, Kirsteen Goodman, Wael Agur et al. (15 authors)

Trials2022-09-0511 citations

10.1186/s13063-022-06681-3

Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.

Hagen S, Kearney R, Goodman K, Melone L, Elders A, Manoukian S, Agur W, Best C, Breeman S, Dembinsky M, Dwyer L, Forrest M, Graham M, Guerrero K, Hemming C, Khunda A, Mason H, McClurg D, Norrie J, Karachalia-Sandri A, Thakar R, Bugge C.

2020-10-0811 citations

10.1186/s13063-020-04738-9

The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation

Carol Bugge, Rohna Kearney, Melanie Dembinsky, Aethele Khunda, Margaret Graham et al. (19 authors)

Trials2020-10-087 citations

10.1186/s13063-020-04729-w

Interventions

Current intervention as of 31/08/2022: Women with any severity or kind of prolapse will be invited to take part in the study as long as they have successfully used a pessary for at least 2 weeks. Elig

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Women with pelvic organ prolapse of any type or stage 2. Aged =18 years 3. Women treated with a vaginal pessary 4. Pessary retained for 2 weeks or more

Exclusion criteria

Exclusion criteria: 1. Women with a shelf or Gellhorn pessary as these are difficult for women to remove and replace themselves 2. Women lacking in manual dexterity, e.g. those with arthritis, as women would not be able to remove and replace her own pessary 3. Women judged by the treating clinician to have a cognitive deficit such that she would be unable to give informed consent or understand self-management instruction 4. Pregnant women

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 31/08/2022: Prolapse-specific quality of life, measured using PFIQ-7 at baseline, 6, 12 and 18 months and 4 years _____ Previous primary outcome measure: Prolapse-specific quality of life, measured using PFIQ-7 at baseline, 6, 12 and 18 months	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 31/08/2022: 1. Generic quality of life, measured using EQ-5D-5L at baseline, 6, 12 and 18 months and 4 years 2. Prolapse symptoms, measured using PFDI-21 at baseline and 18 months and 4 years 3. Sexual dysfunction, measured using PISQ-12 at baseline and 18 months and 4 years 4. Need for other prolapse treatment, measured at 6, 12 and 18 months and 4 years 5. Self-efficacy, measured using GSE/SESPPFE at baseline and 18 months and 4 years 6. Treatment acceptability, measured at at baseline and 18 months and 4 years 7. Patterns of pessary use, measured at baseline, 6, 12 and 18 months and 4 years 8. Pessary complications, measured at baseline, 6, 12 and 18 months and 4 years 9. Pessary discontinuation, measured at baseline, 6, 12 and 18 months and 4 years 10. Adherence to self-management/standard pessary care, measured continuously throughout trial 11. Crossover to other group, measured continuously throughout trial 12. Everyday physical activity assessed using the International Physical Activity Questionnaire modified for the elderly (IPAQ-E) at 4 years. The four questions ask about the amount of time in days and minutes, people spend sitting, walking, doing moderate and vigorous physical activity in the last 7 days. _____ Previous secondary outcome measures: 1. Generic quality of life, measured using EQ-5D-5L at baseline, 6, 12 and 18 months 2. Prolapse symptoms, measured using PFDI-21 at baseline and 18 months 3. Sexual dysfunction, measured using PISQ-12 at baseline and 18 months 4. Need for other prolapse treatment, measured at 6, 12 and 18 months 5. Self-efficacy, measured using GSE/SESPPFE at baseline and 18 months 6. Treatment acceptability, measured at at baseline and 18 months 7. Patterns of pessary use, measured at baseline, 6, 12 and 18 months 8. Pessary complications, measured at baseline, 6, 12 and 18 months 9. Pessary discontinuation, measured at baseline, 6, 12 and 18 months 10. Adherence to self-management/s	—

Measure

Time frame

Current secondary outcome measures as of 31/08/2022: 1. Generic quality of life, measured using EQ-5D-5L at baseline, 6, 12 and 18 months and 4 years 2. Prolapse symptoms, measured using PFDI-21 at baseline and 18 months and 4 years 3. Sexual dysfunction, measured using PISQ-12 at baseline and 18 months and 4 years 4. Need for other prolapse treatment, measured at 6, 12 and 18 months and 4 years 5. Self-efficacy, measured using GSE/SESPPFE at baseline and 18 months and 4 years 6. Treatment acceptability, measured at at baseline and 18 months and 4 years 7. Patterns of pessary use, measured at baseline, 6, 12 and 18 months and 4 years 8. Pessary complications, measured at baseline, 6, 12 and 18 months and 4 years 9. Pessary discontinuation, measured at baseline, 6, 12 and 18 months and 4 years 10. Adherence to self-management/standard pessary care, measured continuously throughout trial 11. Crossover to other group, measured continuously throughout trial 12. Everyday physical activity assessed using the International Physical Activity Questionnaire modified for the elderly (IPAQ-E) at 4 years. The four questions ask about the amount of time in days and minutes, people spend sitting, walking, doing moderate and vigorous physical activity in the last 7 days. _____ Previous secondary outcome measures: 1. Generic quality of life, measured using EQ-5D-5L at baseline, 6, 12 and 18 months 2. Prolapse symptoms, measured using PFDI-21 at baseline and 18 months 3. Sexual dysfunction, measured using PISQ-12 at baseline and 18 months 4. Need for other prolapse treatment, measured at 6, 12 and 18 months 5. Self-efficacy, measured using GSE/SESPPFE at baseline and 18 months 6. Treatment acceptability, measured at at baseline and 18 months 7. Patterns of pessary use, measured at baseline, 6, 12 and 18 months 8. Pessary complications, measured at baseline, 6, 12 and 18 months 9. Pessary discontinuation, measured at baseline, 6, 12 and 18 months 10. Adherence to self-management/s

—

Countries

England, United Kingdom

Outcome results

None listed