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

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.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Training of pelvic floor muscles; Procedure: Hipopressive abdominal gymnastics

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38400-678
      • Luciene Aparecida José Vaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women with IUE and with a modified Oxford scale of at least 1.

Exclusion Criteria:

• Presence of neuromuscular diseases
• Uncontrolled diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Training of pelvic floor muscles	Procedure: Training of pelvic floor muscles; 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.
Experimental: Hipopressive abdominal gymnastics	Procedure: Hipopressive abdominal gymnastics; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire Short Form	Self-administered questionnaire to evaluate the impact of incontinence on the life of the research participant.	two months
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.	two months
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.	two months
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.	two months

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Investigators: Principal Investigator: Luciene Aparecida Vaz, Federal University of Uberlandia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 26, 2017
• Study Completion (Anticipated): August 26, 2020

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 1.516.103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No