Pelvic organ prolapse Urological and Genital Diseases
Conditions
Interventions
Supervised pelvic floor muscle training (PFMT) is an effective non-surgical option for treating and preventing prolapse symptoms and is first-line management. A vaginal pessary, a support device inser
Sponsors
Glasgow Caledonian University
Eligibility
Sex/Gender
Female
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Women who have been referred for PFMT for prolapse, even if they have had previous prolapse treatment (PFMT, pessary, surgery) as currently PFMT would be offered for all such women. If a woman has significant vaginal tissue atrophy, participation in the trial would be delayed until after this has been treated.
Exclusion criteria
Exclusion criteria: 1. Women for whom prolapse is not the main presenting problem 2. Women currently using a vaginal pessary (unless they discontinue for 1 month) 3. Women who are pregnant or less than 6 months postnatal 4. Women having active treatment for pelvic cancer 5. Women with severe vulval disease 6. Women who have cognitive impairment affecting capacity to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant-reported symptoms of pelvic floor dysfunction measured using the Pelvic Floor Dysfunction Inventory-20 (PFDI-20) questionnaire at baseline, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Participant-reported condition-specific quality of life measured using the Pelvic Floor Impact Questionnaire-7 (PFIQ-7) at baseline, 6 and 12 months 2. Patient-reported generic quality of life measured using the general health-related quality of life questionnaire (EQ-5D-5L) at baseline, 6 and 12 months 3. Patient-reported improvement in condition measured using the Global Impression of Improvement (PGI-I) scale validated for prolapse at 6 and 12 months, compared to Patient Global Impression of Severity (PGI-S) at baseline 4. Patient-reported sexual function measured using ICIQ-Vaginal Symptoms module (ICIQ-VS), Sexual Matters subscale at baseline, 6 and 12 months 5. Patient-reported uptake of other prolapse treatment measured using items on unvalidated items on the participant questionnaire at baseline, 6 and 12 months 6. Patient-reported self-efficacy for Pelvic Floor Muscle Training measured using Pelvic Floor Muscle Exercise Self-efficacy Scale at baseline, 6 and 12 months 7. Patient-reported intervention adherence measured using the participant exercise and pessary use diary completed for 7 days at 4 timepoints during the intervention period, and 6 and 12-month questionnaires 8. Pelvic floor muscle strength and function measured using the Modified Oxford Scale (MOS), assessed by a clinician via digital palpation at baseline and 12 months 9. Prolapse severity measured by a clinician using a Pelvic Organ Prolapse Quantification (POP-Q) method at baseline and 12 months 10. Economic outcomes measured using Quality Adjusted Life Years (QALYS) calculated from the EQ-5D-5L at baseline, 6 and 12 months 11. Economic outcomes measured using the Healthcare utilisation questionnaire at baseline, 6 and 12 months | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactSuzanne;Catriona Hagen;O’Dolan
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Outcome results
None listed