Clinical trial NCT01612637: Can Pelvic Floor Muscle Training Reduce my Prolapse
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Pelvic floor muscle training
Prolapse symptoms
Pelvic organ prolapse quantification system
Ultrasonography
Predictors
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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
* Dementia
* Pregnancy or less than one year postnatal
* Disorders that can affect ability to participate in the intervention such as neurological or psychiatric disorders

Primary outcomes:
measure: Patient Global Index of Improvement scale (PGI-I)
timeFrame: three months after ended intervention
Secondary outcomes:
measure: Objective pelvic organ prolapse measured with the pelvic organ prolapse Quantification system (POP-Q)
timeFrame: before, right after, three and 12 months after the intervention has ended
measure: Pelvic Floor Distress Inventory - short form 20 (PFDI-20)
timeFrame: right after, three months and 12 months after ended intervention
measure: Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
timeFrame: right after, three months and 12 months after ended intervention
measure: Background variables
timeFrame: At time of inclusion
measure: Size of levator hiatus and presence of levator ani avulsions examined through transperineal ultrasound
timeFrame: At time of inclusion
measure: Cost-effectiveness
timeFrame: 12 months after ended intervention
measure: Patient Global Index of Improvement scale (PGI-I)
timeFrame: Right after ended intervention and 12 months after ended intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital at Herlev
Study officials:
References: