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
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Women, Pelvic Floor Muscles
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).
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
NCT ID
NCT03514147
First Posted
April 20, 2018
Last Updated
May 1, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
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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