Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy

Not Applicable

Completed

• Conditions: Weak; Pelvic Floor; Urinary Incontinence; Weak; Muscle
• Interventions: Behavioral: pelvic floor muscle training

• Registration Number: NCT02549729
• Lead Sponsor: University of Sao Paulo

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).

The electromyography was not performed because during the collection of data from the pilot sample there was an excess of outcome measures which made the patients' adhesion unfeasible.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	pelvic floor muscle training	Experimental group not using hormonal replacement therapy will receive supervised pelvic floor muscle training.
Exercise and Hormone Therapy	pelvic floor muscle training	Experimental group using hormonal replacement therapy will receive supervised pelvic floor muscle training.

Primary Outcome Measures

Name	Time	Method
Change in Pelvic floor muscle function, evaluated by Perineometry, up to 12 weeks.	Baseline measurement of pelvic floor muscle function, and up to 12 weeks. Control group will be evaluated at baseline and up to 12 weeks.

Trial Locations

Locations (1)

School Healthy Center; 🇧🇷 Ribeirão Preto, São Paulo, Brazil