Effects of Training of Pelvic Floor Muscles (MAP) on Stress Urinary Incontinence
Effects of Pelvic Floor Muscle Training or Hipopressive Abdominal Gymnastics in the Treatment of Women's Stress Urinary Incontinence: a Prospective, Randomized, Controlled Study
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2020
CompletedOctober 19, 2018
October 1, 2018
25 days
June 26, 2017
October 18, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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.
two months
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.
two months
Secondary Outcomes (4)
International Consultation on Incontinence Questionnaire Short Form
two months
Pelvic Floor Impact Questionnaire (PFIQ-7) Floor Impact Questionnaire (PFIQ-7)
two months
Pelvic Floor Distress Inventory (PFDI-20)
two months
Void diary
two months
Study Arms (2)
Training of pelvic floor muscles
ACTIVE COMPARATORHipopressive abdominal gymnastics
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Women with IUE and with a modified Oxford scale of at least 1.
You may not qualify if:
- Presence of neuromuscular diseases
- Uncontrolled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Luciene Aparecida José Vaz
Uberlândia, Minas Gerais, 38400-678, Brazil
Related Publications (1)
Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PMID: 39704322DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luciene Aparecida Vaz
Federal University of Uberlandia
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
- Principal Investigator
Study Record Dates
First Submitted
June 26, 2017
First Posted
June 29, 2017
Study Start
September 1, 2017
Primary Completion
September 26, 2017
Study Completion
August 26, 2020
Last Updated
October 19, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share