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Can Pelvic Floor Muscle Training Reduce my Prolapse

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01612637
First received: June 4, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Pelvic Organ Prolapse
Behavioral: Pelvic floor muscle training and lifestyle advice
Behavioral: Lifestyle advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Patient Global Index of Improvement scale (PGI-I) [ Time Frame: three months after ended intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective pelvic organ prolapse measured with the pelvic organ prolapse Quantification system (POP-Q) [ Time Frame: before, right after, three and 12 months after the intervention has ended ] [ Designated as safety issue: No ]
  • Pelvic Floor Distress Inventory - short form 20 (PFDI-20) [ Time Frame: right after, three months and 12 months after ended intervention ] [ Designated as safety issue: No ]
    Validated condition-specific questionnaire

  • Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7) [ Time Frame: right after, three months and 12 months after ended intervention ] [ Designated as safety issue: No ]
    Validated condition-specific questionnaire

  • Background variables [ Time Frame: At time of inclusion ] [ Designated as safety issue: No ]
    age, parity, BMI, working status as predictors of effect of the intervention

  • Size of levator hiatus and presence of levator ani avulsions examined through transperineal ultrasound [ Time Frame: At time of inclusion ] [ Designated as safety issue: No ]
    as predictors of effect of the intervention

  • Cost-effectiveness [ Time Frame: 12 months after ended intervention ] [ Designated as safety issue: No ]
    Need for further treatment and calculation of economic costs for both interventions compared to number of surgeries avoided will be evaluated

  • Patient Global Index of Improvement scale (PGI-I) [ Time Frame: Right after ended intervention and 12 months after ended intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: August 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
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 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.
Active Comparator: Group 2
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612637

Locations
Denmark
Copenhagen University Hospital at Herlev
Copenhagen, Denmark, DK - 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01612637     History of Changes
Other Study ID Numbers: H-4-2011-072
Study First Received: June 4, 2012
Last Updated: July 30, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Pelvic organ prolapse
Pelvic floor muscle training
Prolapse symptoms
Pelvic organ prolapse quantification system
Ultrasonography
Predictors

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014