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Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PFMT in group
PFMT at home
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 Physiotherapy, Pelvic floor, Urinary Incontinence

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Be female;
  • Have urinary incontinence;
  • Between 30 and 70 years old;
  • Have had 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:

  • Have allergy to latex;
  • 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 PFMT in the last 6 months;
  • Have contraction of the pelvic floor muscles grade zero (0).

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PFMT in group

PFMT at home

Arm Description

Participants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again.

Randomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again.

Outcomes

Primary Outcome Measures

Functionality of pelvic floor muscles
Capacity of voluntary contraction that reduces light and vaginal length, generating intravaginal pressure, in the case of this study evaluated by PERFECT Scale.

Secondary Outcome Measures

Sexual function
A set of four successive stages: desire, arousal, orgasm and resolution, which have subjective, interpersonal, psychological, muscular and reflex characteristics, in the case of this study evaluated by the Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire (PISQ-12) .
Quality of life in urinary incontinence
The presence of urinary incontinence causes a substantial and substantial negative impact on the quality of life of women living with this symptom. This impact on quality of life can be measured by the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).

Full Information

First Posted
October 19, 2017
Last Updated
March 4, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03500185
Brief Title
Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence
Official Title
Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence: a Randomized Clinical Test
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to compare the efficacy of a protocol, pelvic floor muscle training (PFMT), applied in a group and at home for urinary incontinence (UI) in women. Probably, the group-applied PFMT protocol is more effective in women with UI than the home protocol.
Detailed Description
Introduction: One of the female pelvic floor (PF) papers is to control urinary continence. Changes in your PF function and structure can cause the dysfunction of the PF. Among these UI is more commonly reported and affects one-third of adult women and generates significant impact on the quality and life of these, including sexual activity. Among the possibilities to treat UI in a conservative manner, the PFMT should be recommended as an intervention of first-line treatment for women with such symptoms. Such training can be developed individually or in a group, just to be prescribed and performed 6-12 weeks to demonstrate such effectiveness. Nevertheless they are still scarce in the literature studies involving the PFMT, group and individual in application, that have validated and well-defined protocols and, in addition, protocols that are easy to understand and play by the patients. Objective: The aim of the study is to compare the efficacy of a protocol of PFMT applied in a group and at home for UI in women. Methodology: The study presents an experimental design type randomized blind clinical trial. The sample is not probabilistic for convenience, which shall contain the minimum number of 28 women in each group, obtained in the sample calculation. Women will be included from age 30 to 70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, and sign the consent form. Women will be excluded with latex allergy, who have made treatment of pelvic radiotherapy, or are undergoing chemotherapy, women who had childbirth in the last 12 months which have participated in PFMT individually or in groups in the past six months. The assessment consists of a medical history form, which will include personal data; the evaluation of the function of PF is performed by the muscles pressure biofeedback apparatus which measures pressure peak contraction of the pelvic floor via a cuff connected to the pressure transducer; to assess the impact of UI on quality of life will use the International Consultation on Incontinence Questionnaire (ICIQ-SF); for evaluation of sexual function is used Pelvic Organ Prolapse Quiz / Urinary Incontinence Sexual Questionnaire (PISQ-12). Statistical analysis will be performed using the Shapiro-Wilk test to verify the normality of the data. Descriptive analysis of parametric data will be expressed as mean and standard deviation, and the nonparametric median and interquartile range. The qualitative variables are expressed as absolute and relative frequency. In the inferential analysis will be used for comparison of continuous variables parametric intragroup, ANOVA and non-parametric variables the Wilcoxon test. In the analysis of categorical variables will be used the McNemar test. As for the inferential analysis will be used for comparison of continuous variables parametric intergroup, ANOVA and non-parametric variables the Mann-Whitney test. In the analysis of categorical variables will be used chi-square test. For all analyzes will be of significance level of 5% (p ≤ 0.05).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Physiotherapy, Pelvic floor, Urinary Incontinence

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PFMT in group
Arm Type
Experimental
Arm Description
Participants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again.
Arm Title
PFMT at home
Arm Type
Active Comparator
Arm Description
Randomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again.
Intervention Type
Other
Intervention Name(s)
PFMT in group
Intervention Description
Participants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again.
Intervention Type
Other
Intervention Name(s)
PFMT at home
Intervention Description
Randomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again.
Primary Outcome Measure Information:
Title
Functionality of pelvic floor muscles
Description
Capacity of voluntary contraction that reduces light and vaginal length, generating intravaginal pressure, in the case of this study evaluated by PERFECT Scale.
Time Frame
Evaluation after 24 weeks
Secondary Outcome Measure Information:
Title
Sexual function
Description
A set of four successive stages: desire, arousal, orgasm and resolution, which have subjective, interpersonal, psychological, muscular and reflex characteristics, in the case of this study evaluated by the Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire (PISQ-12) .
Time Frame
Evaluation after 24 weeks
Title
Quality of life in urinary incontinence
Description
The presence of urinary incontinence causes a substantial and substantial negative impact on the quality of life of women living with this symptom. This impact on quality of life can be measured by the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).
Time Frame
Evaluation after 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be female; Have urinary incontinence; Between 30 and 70 years old; Have had 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: Have allergy to latex; 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 PFMT 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
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

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Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary Incontinence

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