Effect of the Pelvic Floor Training on Pelvic Floor Muscle Strength in Postmenopausal Women With or Without Hormonal Therapy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Change in Pelvic floor muscle function, evaluated by Perineometry, up to 12 weeks.
Study Overview
Brief Summary
The purpose of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on muscle function of postmenopausal women using or not using hormonal therapy replacement (HTR). The study will evaluate also the prevalence of urinary incontinence reports, its severity and impact on quality of life.
Detailed Description
The climacteric period is marked by the decline of estrogens and androgens which represents negative effect on the urogenital system and may present, as a consequence, pelvic floor muscles (PFM) dysfunction and urinary incontinence (UI). The pelvic floor muscles training (PFMT) and hormone therapy (HT) could result in a significant increase in muscle mass with functional improvement and consequent decrease in complaints of urine loss. The aim of this study is to evaluate the effect of PFMT on muscle function, in the presence of UI, severity and impact on quality of life in postmenopausal women with or without HT.
The variable sexual function was abandoned due to the fact that the majority of the women do not presented active sexual life, which is a criteria to answer the questionnaire Index of Female Sexual Function (IFSF), or did not agree to answer the questionnaire. The anxiety scale was also abandoned because it was a tool to assess sexual function in a broader way.
This is a randomized controlled trial. Postmenopausal women will be divided into 4 groups:
- Group 1- without exercise and without HT
- Group 2 - with exercise and without HT
- Group 3 - without exercise and with HT
- Group 4 - with exercise and HT
Women will be evaluated at baseline and up to 12 weeks. The evaluations of the PFM function will be accomplished through the use of vaginal palpation using the Modified Oxford Scale (MOS) and perineometry. The International Consultation on Incontinence Questionnaire- Short Form (ICIQ - SF) will be used to assess reports of UI, quality of life will be evaluated by the SF36 (Medical Outcomes Study 36 - Item Short - Form Health Survey).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Postmenopausal women with a maximum of ten years of menopause.
- •It is considered menopausal cessation of menstrual cycles for more than twelve months (WHO).
- •To be included women must have the ability to contract the pelvic floor muscle (PFM) and have never done PFM training.
Exclusion Criteria
- •Women with diabetes mellitus, thyroid disease, hyperprolactinemia, genital prolapse (above grade 1), neuropathy and vasculopathy.
- •Those who are intolerant (pain, allergy gel or latex condom or other discomfort) to PFM function evaluation and those that deny answer the questionnaires during the protocol.
Arms & Interventions
Control
Control group not using hormonal replacement therapy will not receive supervised pelvic floor muscle training. This group will be assessed at baseline and up to 12 weeks. For ethics reason at the end of the study women of the control group will be invited to receive the pelvic floor muscle training program. However, this will not be part of the study.
Exercise
Experimental group not using hormonal replacement therapy will receive supervised pelvic floor muscle training.
Intervention: pelvic floor muscle training (Behavioral)
Hormone Therapy
Experimental group using hormonal replacement therapy will not receive supervised pelvic floor muscle training.
Exercise and Hormone Therapy
Experimental group using hormonal replacement therapy will receive supervised pelvic floor muscle training.
Intervention: pelvic floor muscle training (Behavioral)
Outcomes
Primary Outcomes
Change in Pelvic floor muscle function, evaluated by Perineometry, up to 12 weeks.
Time Frame: Baseline measurement of pelvic floor muscle function, and up to 12 weeks. Control group will be evaluated at baseline and up to 12 weeks.
Secondary Outcomes
No secondary outcomes reported
Investigators
Flávia Ignácio Antônio Vassimon
PT Master Degree
University of Sao Paulo