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Can Pelvic Floor Muscle Training Reduce my Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pelvic floor muscle training and lifestyle advice
Lifestyle advice
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Pelvic floor muscle training, Prolapse symptoms, Pelvic organ prolapse quantification system, Ultrasonography, Predictors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Copenhagen University Hospital at Herlev

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Patient Global Index of Improvement scale (PGI-I)

Secondary Outcome Measures

Objective pelvic organ prolapse measured with the pelvic organ prolapse Quantification system (POP-Q)
Pelvic Floor Distress Inventory - short form 20 (PFDI-20)
Validated condition-specific questionnaire
Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
Validated condition-specific questionnaire
Background variables
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
as predictors of effect of the intervention
Cost-effectiveness
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)

Full Information

First Posted
June 4, 2012
Last Updated
February 2, 2016
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT01612637
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Pelvic organ prolapse, Pelvic floor muscle training, Prolapse symptoms, Pelvic organ prolapse quantification system, Ultrasonography, Predictors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training and lifestyle advice
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle advice
Intervention Description
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
Primary Outcome Measure Information:
Title
Patient Global Index of Improvement scale (PGI-I)
Time Frame
three months after ended intervention
Secondary Outcome Measure Information:
Title
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
Title
Pelvic Floor Distress Inventory - short form 20 (PFDI-20)
Description
Validated condition-specific questionnaire
Time Frame
right after, three months and 12 months after ended intervention
Title
Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
Description
Validated condition-specific questionnaire
Time Frame
right after, three months and 12 months after ended intervention
Title
Background variables
Description
age, parity, BMI, working status as predictors of effect of the intervention
Time Frame
At time of inclusion
Title
Size of levator hiatus and presence of levator ani avulsions examined through transperineal ultrasound
Description
as predictors of effect of the intervention
Time Frame
At time of inclusion
Title
Cost-effectiveness
Description
Need for further treatment and calculation of economic costs for both interventions compared to number of surgeries avoided will be evaluated
Time Frame
12 months after ended intervention
Title
Patient Global Index of Improvement scale (PGI-I)
Time Frame
Right after ended intervention and 12 months after ended intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Copenhagen University Hospital at Herlev
City
Copenhagen
ZIP/Postal Code
DK - 2730
Country
Denmark

12. IPD Sharing Statement

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