Can Pelvic Floor Muscle Training Reduce my Prolapse? A Randomised Controlled Trial Comparing the Effect of Pelvic Floor Muscle Training and Lifestyle Advice on Pelvic Organ Prolapse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Patient Global Index of Improvement scale (PGI-I)
Study Overview
Brief Summary
Purpose The aim of this study is to examine if a structured pelvic floor muscle training combined with lifestyle advice with can improve pelvic organ prolapse (POP) symptoms more than structured lifestyle advice programme alone.
Background Pelvic organ prolapse (POP) is a common condition among adult women and almost one in ten women experience symptoms caused by POP. The key symptom of POP is seeing or feeling a bulge in the vaginal opening but POP often gives other symptoms, such as pain, difficulty emptying the bladder or the bowel, incontinence and sexual problems such as dyspareunia.
A majority of women with POP will be offered reconstructive surgery but the risk of reoperations is substantial and surgery may cause new symptoms. In one out of four women surgery does not relieve symptoms and the women have been exposed to unnecessary risk of complications.
It is therefore important to evaluate the effect of conservative treatments for POP. New studies have shown that pelvic floor muscle training offered in combination with lifestyle advice has a significant on POP symptoms and objective measures of POP compared to a lifestyle advice leaflet alone.
No studies have compared the effect of a combined pelvic floor muscle training and lifestyle advice programme with a structured programme of lifestyle advice and hypothetically the structured lifestyle advice programme could have a substantial effect on its own. Our hypothesis is that the pelvic floor muscle training is a vital component of a conservative treatment for POP.
Methods In this single-blind randomised controlled study women with POP will randomised to either a programme of structured pelvic floor muscle training combined with lifestyle advice or a structured lifestyle advice programme alone. Both groups will receive the same lifestyle advices through six (separate) lectures within 12 weeks. The training group will be examined and individually instructed in pelvic floor muscle training before the intervention starts and they will, in continuation with their lifestyle lectures, perform pelvic floor muscle training as group training
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age female reporting bothersome symptoms of any type of POP
- •Newly referred to the hospital clinic
- •Prolapse ≥II POP-Q
- •Understand and write Danish
Exclusion Criteria
- •Instruction in pelvic floor muscle training within the last two years
- •Pregnancy or less than one year postnatal
- •Disorders that can affect ability to participate in the intervention such as neurological or psychiatric disorders
Outcomes
Primary Outcomes
Patient Global Index of Improvement scale (PGI-I)
Time Frame: three months after ended intervention
Secondary Outcomes
- Background variables(At time of inclusion)
- Size of levator hiatus and presence of levator ani avulsions examined through transperineal ultrasound(At time of inclusion)
- Cost-effectiveness(12 months after ended intervention)
- Patient Global Index of Improvement scale (PGI-I)(Right after ended intervention and 12 months after ended intervention)
- Objective pelvic organ prolapse measured with the pelvic organ prolapse Quantification system (POP-Q)(before, right after, three and 12 months after the intervention has ended)
- Pelvic Floor Distress Inventory - short form 20 (PFDI-20)(right after, three months and 12 months after ended intervention)
- Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)(right after, three months and 12 months after ended intervention)