Effects of Training of Pelvic Floor Muscles (MAP) on Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Training of pelvic floor muscles
Hipopressive abdominal gymnastics
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Women with IUE and with a modified Oxford scale of at least 1.
Exclusion Criteria:
- Presence of neuromuscular diseases
- Uncontrolled diabetes
Sites / Locations
- Luciene Aparecida José Vaz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Training of pelvic floor muscles
Hipopressive abdominal gymnastics
Arm Description
Outcomes
Primary Outcome Measures
Check for modification on modified oxford scale
Bidigital palpation will be performed in the vagina and requested the maximum voluntary contraction of the pelvic floor muscles.
Check for modification on Perineometry
A silicone probe will be introduced into the vaginal cavity, and then it will be inflated to 100 cm / H2O, and reset. After this will be requested the maximum voluntary contraction maintained for 5 seconds, with interval of 1 minute to rest and after it will be repeated twice.
Secondary Outcome Measures
International Consultation on Incontinence Questionnaire Short Form
Self-administered questionnaire to evaluate the impact of incontinence on the life of the research participant.
Pelvic Floor Impact Questionnaire (PFIQ-7) Floor Impact Questionnaire (PFIQ-7)
A self-administered questionnaire that presents seven questions to evaluate the impact of each subsession on the participant's quality of life.
Pelvic Floor Distress Inventory (PFDI-20)
A self-administered questionnaire composed of 20 questions applied to assess the impact of each domain on the life of the research participant.
Void diary
Diary delivered to the participant to note for seven days the urinary frequency daytime, night, amount of loss and exchange of absorbents if you use.
Full Information
NCT ID
NCT03203798
First Posted
June 26, 2017
Last Updated
October 18, 2018
Sponsor
Federal University of Uberlandia
1. Study Identification
Unique Protocol Identification Number
NCT03203798
Brief Title
Effects of Training of Pelvic Floor Muscles (MAP) on Stress Urinary Incontinence
Official Title
Effects of Pelvic Floor Muscle Training or Hipopressive Abdominal Gymnastics in the Treatment of Women's Stress Urinary Incontinence: a Prospective, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 26, 2017 (Actual)
Study Completion Date
August 26, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In the current scientific literature, it is clear that SUI can cause several social, hygienic and personal relationship problems. It has also been proven that this condition affects many more menopausal women than menacme, and this is believed to be due to the hypoestrogenism characteristic of this phase.
On the other hand, weakness of the pelvic floor muscles (PFM) is also related to the genesis of SUI. The role of these muscles would be to keep the bladder neck elevated (above the pubic symphysis) during increases in abdominal pressure, and its weakness would lead to excessive lowering of the bladder neck at these times, leading to SUI due to bladder neck hypermobility.
The conservative treatment of this condition, therefore, encompasses the strengthening of PFMs, which would avoid excessive descent of the bladder neck during increases in abdominal pressure, thereby reducing urinary loss.
In the current literature there are studies proving the effectiveness of pelvic floor muscle training; however, in relation to the literature on abdominal hipopressive gymnastics, it is observed that the scientific evidence is still poor, however, the technique is still Widely spread through extension courses offered throughout Latin America, France and Spain; With regard to the comparison of these methods with respect to their clinical efficacy and the quality of life and patient satisfaction, there are no consistent studies, and this fact motivated us to carry out this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training of pelvic floor muscles
Arm Type
Active Comparator
Arm Title
Hipopressive abdominal gymnastics
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Training of pelvic floor muscles
Intervention Description
The pelvic floor muscle training group will be composed of randomized women and participated for 12 weeks of intervention, where it was performed in groups of a maximum of 4 patients, starting in the first 4 weeks with 3 sets of 8 repetitions of contraction maintained for 5 seconds In antigravity postures, with two lying postures and one sitting posture, and evolving to the next 4 weeks for 3 sets with 10 repetitions of contraction maintained for 5 seconds being a lying posture, a seated posture and orthostatic posture in the last 4 weeks 3 Series of 12 repetitions of contraction maintained for 5 seconds in the gravitational postures, being one sitting posture and two orthostatic postures.
Intervention Type
Procedure
Intervention Name(s)
Hipopressive abdominal gymnastics
Intervention Description
The hipopressiva abdominal gymnastics group will be composed of randomized women who participated for 12 weeks of intervention, where it was performed in groups of a maximum of 4 patients, being performed respecting the basic sequence of the exercise proposed by Marcel Caufriez: 1) Inspiration, 2) Maximum Expiration, 3) Diaphragmatic aspiration being performed 3 series of 8 to 12 repetitions. The exercises will be performed in groups of a maximum of 4 patients, starting in the first 4 weeks with 3 sets of 8 repetitions in antigravity postures, with two lying postures and one sitting posture, and evolving over the next 4 weeks to 3 sets with 10 repetitions A lying posture, a sitting posture and orthostatic posture, in the last 4 weeks 3 sets of 12 repetitions in the gravitational postures, being a sitting posture and two orthostatic postures.
Primary Outcome Measure Information:
Title
Check for modification on modified oxford scale
Description
Bidigital palpation will be performed in the vagina and requested the maximum voluntary contraction of the pelvic floor muscles.
Time Frame
two months
Title
Check for modification on Perineometry
Description
A silicone probe will be introduced into the vaginal cavity, and then it will be inflated to 100 cm / H2O, and reset. After this will be requested the maximum voluntary contraction maintained for 5 seconds, with interval of 1 minute to rest and after it will be repeated twice.
Time Frame
two months
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire Short Form
Description
Self-administered questionnaire to evaluate the impact of incontinence on the life of the research participant.
Time Frame
two months
Title
Pelvic Floor Impact Questionnaire (PFIQ-7) Floor Impact Questionnaire (PFIQ-7)
Description
A self-administered questionnaire that presents seven questions to evaluate the impact of each subsession on the participant's quality of life.
Time Frame
two months
Title
Pelvic Floor Distress Inventory (PFDI-20)
Description
A self-administered questionnaire composed of 20 questions applied to assess the impact of each domain on the life of the research participant.
Time Frame
two months
Title
Void diary
Description
Diary delivered to the participant to note for seven days the urinary frequency daytime, night, amount of loss and exchange of absorbents if you use.
Time Frame
two months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with IUE and with a modified Oxford scale of at least 1.
Exclusion Criteria:
Presence of neuromuscular diseases
Uncontrolled diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciene Aparecida Vaz
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luciene Aparecida José Vaz
City
Uberlândia
State/Province
Minas Gerais
ZIP/Postal Code
38400-678
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Training of Pelvic Floor Muscles (MAP) on Stress Urinary Incontinence
We'll reach out to this number within 24 hrs