NCT02549729

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

Effect of the Pelvic Floor Training on Pelvic Floor Muscle Strength in Postmenopausal Women With or Without Hormonal Therapy: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-09-15
• Last updated: 2017-03-17

Locations

1 site across 1 country: Brazil