Can Pelvic Floor Muscle Training Reduce my Prolapse

NCT01612637 | Completed DMC

• 1 other identifier: H-4-2011-072
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse; Pelvic floor muscle training; Prolapse symptoms; Pelvic organ prolapse quantification system; Ultrasonography; Predictors

Outcome Measures

Primary Outcomes (1)

• Patient Global Index of Improvement scale (PGI-I)

  three months after ended intervention

Secondary Outcomes (7)

• 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

• Background variables

  At time of inclusion

• Size of levator hiatus and presence of levator ani avulsions examined through transperineal ultrasound

  At time of inclusion

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 will be individually examined and instructed in pelvic floor muscle training before the intervention starts by specialized physiotherapists. The examination includes a vaginal or an anal examination. The women attend six group sessions within 12 weeks containing structured information about POP and the possible affection of POP on quality of life, exercising and sexual relationship. The lifestyle advice contains information about life style changes that could improve POP symptoms, such as bladder and bowel habits, coughing, heavy lifting, eating habits and weight loss. The women will perform pelvic floor muscle training in the group and they will perform pelvic floor muscle training at home. The training will be individually planned according to the findings of the pelvic floor physiotherapist. The women in the intervention group fill in an exercise diary and also describe on a Visual Analog Scale if the training causes any bother.

Behavioral: Pelvic floor muscle training and lifestyle advice

Group 2

ACTIVE COMPARATOR

Group 2 attend six group sessions within 12 weeks containing structured information about POP and the possible affection of POP on quality of life, exercising and sexual relationship. The lifestyle advice contains information about life style changes that could improve POP symptoms, such as bladder and bowel habits, coughing, heavy lifting, eating habits and weight loss

Behavioral: Lifestyle advice

Interventions

Pelvic floor muscle training and lifestyle advice BEHAVIORAL

Group 1 will be individually examined and instructed in pelvic floor muscle training before the intervention starts by specialized physiotherapists. The examination includes a vaginal or an anal examination. The women attend six group sessions within 12 weeks containing structured information about POP and the possible affection of POP on quality of life, exercising and sexual relationship and information that could improve POP symptoms, such as bladder and bowel habits, coughing, heavy lifting, eating habits and weight loss. The women will perform pelvic floor muscle training in the group and perform pelvic floor muscle training at home. The training will be individually planned according to the findings of the pelvic floor physiotherapist. The women in the intervention group fill in an exercise diary and also describe on a Visual Analog Scale if the training causes any bother.

Group 1

Lifestyle advice BEHAVIORAL

Group 2 attend six group sessions within 12 weeks containing structured information about POP and the possible affection of POP on quality of life, exercising and sexual relationship. The lifestyle advice contains information about life style changes that could improve POP symptoms, such as bladder and bowel habits, coughing, heavy lifting, eating habits and weight loss

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Copenhagen University Hospital at Herlev

Copenhagen, DK - 2730, Denmark

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 6, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2014-07

Locations

DK (1)