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

NCT02549729 | Completed DMC

• 1 other identifier: 1.076.422
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Weak; Pelvic Floor; Weak; Muscle; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Control

NO INTERVENTION

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

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

Behavioral: pelvic floor muscle training

Hormone Therapy

NO INTERVENTION

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

Exercise and Hormone Therapy

EXPERIMENTAL

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

Behavioral: pelvic floor muscle training

Interventions

pelvic floor muscle training 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.

Exercise; Exercise and Hormone Therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School Healthy Center

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 29914808 DERIVED

MeSH Terms

Conditions

Asthenia; Urinary Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT Master Degree

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

BR (1)