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Can Pelvic Floor Muscle Training Reduce my Prolapse

2 lutego 2016 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Warunki

Wypadanie narządów miednicy mniejszej

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

108

Faza

Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Randomizowane
Model interwencyjny: Przydział równoległy
Maskowanie: Pojedynczy

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm	Interwencja / Leczenie
Eksperymentalny: 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.	Behawioralne: 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.
Aktywny komparator: 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	Behawioralne: 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

Grupa uczestników / Arm

Interwencja / Leczenie

Eksperymentalny: 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.

Behawioralne: 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.

Aktywny komparator: 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

Behawioralne: Lifestyle advice

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Ramy czasowe
Patient Global Index of Improvement scale (PGI-I) Ramy czasowe: three months after ended intervention	three months after ended intervention

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Objective pelvic organ prolapse measured with the pelvic organ prolapse Quantification system (POP-Q) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: At time of inclusion	as predictors of effect of the intervention	At time of inclusion
Cost-effectiveness Ramy czasowe: 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) Ramy czasowe: Right after ended intervention and 12 months after ended intervention		Right after ended intervention and 12 months after ended intervention

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Copenhagen University Hospital at Herlev

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 sierpnia 2012

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2015

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2015

Daty rejestracji na studia

Pierwszy przesłany

4 czerwca 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 czerwca 2012

Pierwszy wysłany (Oszacować)

6 czerwca 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

3 lutego 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lutego 2016

Ostatnia weryfikacja

1 lipca 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

H-4-2011-072

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Can Pelvic Floor Muscle Training Reduce my Prolapse