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

NCT ID: NCT02549729

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

Weak; Pelvic Floor; Weak; Muscle; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise

Experimental group not using hormonal replacement therapy will receive supervised pelvic floor muscle training.

Group Type: EXPERIMENTAL

pelvic floor muscle training

Intervention Type: BEHAVIORAL

Women will be instructed to perform pelvic floor muscle training daily at home 4 sets of 10 maximum perceived voluntary contraction of the pelvic floor muscle sustained for 6 seconds followed by 5 flick voluntary contraction of the pelvic floor muscle. The 4 sets will be performed in 4 different positions (supine, all four, sit and standing). Twice a week they will receive a supervised session using the same protocol described above.

Hormone Therapy

Experimental group using hormonal replacement therapy will not receive supervised pelvic floor muscle training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise and Hormone Therapy

Experimental group using hormonal replacement therapy will receive supervised pelvic floor muscle training.

Group Type: EXPERIMENTAL

pelvic floor muscle training

Intervention Type: BEHAVIORAL

Women will be instructed to perform pelvic floor muscle training daily at home 4 sets of 10 maximum perceived voluntary contraction of the pelvic floor muscle sustained for 6 seconds followed by 5 flick voluntary contraction of the pelvic floor muscle. The 4 sets will be performed in 4 different positions (supine, all four, sit and standing). Twice a week they will receive a supervised session using the same protocol described above.

Interventions

pelvic floor muscle training

Women will be instructed to perform pelvic floor muscle training daily at home 4 sets of 10 maximum perceived voluntary contraction of the pelvic floor muscle sustained for 6 seconds followed by 5 flick voluntary contraction of the pelvic floor muscle. The 4 sets will be performed in 4 different positions (supine, all four, sit and standing). Twice a week they will receive a supervised session using the same protocol described above.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Flávia Ignácio Antônio Vassimon

PT Master Degree

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School Healthy Center

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

Ignacio Antonio F, Herbert RD, Bo K, Rosa-E-Silva ACJS, Lara LAS, Franco MM, Ferreira CHJ. Pelvic floor muscle training increases pelvic floor muscle strength more in post-menopausal women who are not using hormone therapy than in women who are using hormone therapy: a randomised trial. J Physiother. 2018 Jul;64(3):166-171. doi: 10.1016/j.jphys.2018.05.002. Epub 2018 Jun 15.

Reference Type: DERIVED

PMID: 29914808 (View on PubMed)

Other Identifiers

1.076.422

Identifier Type: -

Identifier Source: org_study_id