Can Pelvic Floor Muscle Training Reduce my Prolapse
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Copenhagen, Dinamarca, DK - 2730
- Copenhagen University Hospital at Herlev
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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Comparador activo: 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
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Patient Global Index of Improvement scale (PGI-I)
Periodo de tiempo: three months after ended intervention
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three months after ended intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Objective pelvic organ prolapse measured with the pelvic organ prolapse Quantification system (POP-Q)
Periodo de tiempo: before, right after, three and 12 months after the intervention has ended
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before, right after, three and 12 months after the intervention has ended
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Pelvic Floor Distress Inventory - short form 20 (PFDI-20)
Periodo de tiempo: right after, three months and 12 months after ended intervention
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Validated condition-specific questionnaire
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right after, three months and 12 months after ended intervention
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Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
Periodo de tiempo: right after, three months and 12 months after ended intervention
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Validated condition-specific questionnaire
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right after, three months and 12 months after ended intervention
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Background variables
Periodo de tiempo: At time of inclusion
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age, parity, BMI, working status as predictors of effect of the intervention
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At time of inclusion
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Size of levator hiatus and presence of levator ani avulsions examined through transperineal ultrasound
Periodo de tiempo: At time of inclusion
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as predictors of effect of the intervention
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At time of inclusion
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Cost-effectiveness
Periodo de tiempo: 12 months after ended intervention
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Need for further treatment and calculation of economic costs for both interventions compared to number of surgeries avoided will be evaluated
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12 months after ended intervention
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Patient Global Index of Improvement scale (PGI-I)
Periodo de tiempo: Right after ended intervention and 12 months after ended intervention
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Right after ended intervention and 12 months after ended intervention
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-4-2011-072
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