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Can Pelvic Floor Muscle Training Reduce my Prolapse

2 februari 2016 bijgewerkt door: Copenhagen University Hospital at Herlev

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

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

Studie Overzicht

Toestand

Voltooid

Conditie

Verzakking van het bekkenorgaan

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

108

Fase

Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Denemarken
- - Copenhagen, Denemarken, DK - 2730
    - Copenhagen University Hospital at Herlev

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Enkel

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: 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.	Gedragsmatig: 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.
Actieve vergelijker: 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	Gedragsmatig: 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

Deelnemersgroep / Arm

Interventie / Behandeling

Experimenteel: 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.

Gedragsmatig: 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.

Actieve vergelijker: 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

Gedragsmatig: Lifestyle advice

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Patient Global Index of Improvement scale (PGI-I) Tijdsspanne: three months after ended intervention	three months after ended intervention

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Objective pelvic organ prolapse measured with the pelvic organ prolapse Quantification system (POP-Q) Tijdsspanne: before, right after, three and 12 months after the intervention has ended		before, right after, three and 12 months after the intervention has ended
Pelvic Floor Distress Inventory - short form 20 (PFDI-20) Tijdsspanne: right after, three months and 12 months after ended intervention	Validated condition-specific questionnaire	right after, three months and 12 months after ended intervention
Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7) Tijdsspanne: right after, three months and 12 months after ended intervention	Validated condition-specific questionnaire	right after, three months and 12 months after ended intervention
Background variables Tijdsspanne: At time of inclusion	age, parity, BMI, working status as predictors of effect of the intervention	At time of inclusion
Size of levator hiatus and presence of levator ani avulsions examined through transperineal ultrasound Tijdsspanne: At time of inclusion	as predictors of effect of the intervention	At time of inclusion
Cost-effectiveness Tijdsspanne: 12 months after ended intervention	Need for further treatment and calculation of economic costs for both interventions compared to number of surgeries avoided will be evaluated	12 months after ended intervention
Patient Global Index of Improvement scale (PGI-I) Tijdsspanne: Right after ended intervention and 12 months after ended intervention		Right after ended intervention and 12 months after ended intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Copenhagen University Hospital at Herlev

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2012

Primaire voltooiing (Werkelijk)

1 april 2015

Studie voltooiing (Werkelijk)

1 april 2015

Studieregistratiedata

Eerst ingediend

4 juni 2012

Eerst ingediend dat voldeed aan de QC-criteria

5 juni 2012

Eerst geplaatst (Schatting)

6 juni 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

3 februari 2016

Laatste update ingediend die voldeed aan QC-criteria

2 februari 2016

Laatst geverifieerd

1 juli 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

H-4-2011-072

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Can Pelvic Floor Muscle Training Reduce my Prolapse