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Pelvic Floor Muscle Training on the Quality of Life in Women With Urinary Incontinence

Primary Purpose

Urinary Incontinence, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental
Control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Women, Pelvic Floor Muscles

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female;
  • Have urinary incontinence;
  • Age between 35 and 70 years;
  • Have sexual intercourse in the last 6 months;
  • Participants should understand the instruments used in the research;
  • Accept to participate in the study and sign the Term of Free and Informed Consent.

Exclusion Criteria:

  • Latex allergy;
  • Have performed or are undergoing pelvic radiotherapy;
  • Be performing chemotherapy treatment;
  • Women who delivered during the last 12 months;
  • Have participated in individual or group MAP training in the last 6 months;
  • Have contraction of the pelvic floor muscles grade zero (0).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    Pelvic Floor Muscle Training in group. Exercise Protocol: The exercise group was supervised and met for 1 hour, one time per week, for 12 weeks. Participants were instructed to perform their respective daily exercises.

    Pelvic Floor Muscle Training in home Exercise Protocol:The same exercise were performed at home for 12 weeks, without supervision. Participants were instructed to perform their respective daily exercises.

    Outcomes

    Primary Outcome Measures

    Quality of life in women with urinary incontinence
    International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 20, 2018
    Last Updated
    May 1, 2018
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03514147
    Brief Title
    Pelvic Floor Muscle Training on the Quality of Life in Women With Urinary Incontinence
    Official Title
    The Effect of Pelvic Floor Muscle Training on the Quality of Life and Functionality in Women With Urinary Incontinence: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim: To assess the influence of pelvic floor muscles group training in the quality of life and functionality of these muscles in women with UI. Study design: This is a randomized controlled trial.
    Detailed Description
    Search location: Urogynecology Ambulatory Care of Porto Alegre Clinical Hospital (HCPA) Patients or participants: Women will be included in aged 35-70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, besides signing an informed consent form. Women will be excluded with latex allergy, who have made pelvic radiotherapy, or be undergoing chemotherapy, puerperal a year, or who use antidepressants and / or anxiolytics. Intervention and measures: The evaluation consists of a medical history form, which will include personal data; the assessment of the MAP function is performed by the pressure biofeedback; for assessment of quality of life will use the questionnaire ICQI-SF and sexual function the PISQ-12 before and after Pelvic Floor Muscle Training. Expected results: To estimate effectiveness of Pelvic Floor Muscle Training in the quality of life and functionality of these muscles in women with urinary incontinence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence, Quality of Life
    Keywords
    Women, Pelvic Floor Muscles

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Pelvic Floor Muscle Training in group. Exercise Protocol: The exercise group was supervised and met for 1 hour, one time per week, for 12 weeks. Participants were instructed to perform their respective daily exercises.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Pelvic Floor Muscle Training in home Exercise Protocol:The same exercise were performed at home for 12 weeks, without supervision. Participants were instructed to perform their respective daily exercises.
    Intervention Type
    Other
    Intervention Name(s)
    Experimental
    Other Intervention Name(s)
    Pelvic Floor Muscle Training in group
    Intervention Description
    Profile of participants: an anamnesis file was used to collect personal data; To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention; To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Other Intervention Name(s)
    Pelvic Floor at Home
    Intervention Description
    Profile of participants: an anamnesis file was used to collect personal data; To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention; To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;
    Primary Outcome Measure Information:
    Title
    Quality of life in women with urinary incontinence
    Description
    International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - scored between 0 and 21.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female; Have urinary incontinence; Age between 35 and 70 years; Have sexual intercourse in the last 6 months; Participants should understand the instruments used in the research; Accept to participate in the study and sign the Term of Free and Informed Consent. Exclusion Criteria: Latex allergy; Have performed or are undergoing pelvic radiotherapy; Be performing chemotherapy treatment; Women who delivered during the last 12 months; Have participated in individual or group MAP training in the last 6 months; Have contraction of the pelvic floor muscles grade zero (0).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    José Geraldo Lopes Ramos
    Organizational Affiliation
    Hospital de Clínicas de Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Pelvic Floor Muscle Training on the Quality of Life in Women With Urinary Incontinence

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