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Clinical Trials/NCT03203798
NCT03203798UnknownNot Applicable

Effects of Pelvic Floor Muscle Training or Hipopressive Abdominal Gymnastics in the Treatment of Women's Stress Urinary Incontinence: a Prospective, Randomized, Controlled Study

Federal University of Uberlandia2 sites in 1 country42 target enrollmentStarted: September 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
42
Locations
2
Primary Endpoint
Check for modification on modified oxford scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Presence of neuromuscular diseases
  • Uncontrolled diabetes

Outcomes

Primary Outcomes

Check for modification on modified oxford scale

Time Frame: two months

Bidigital palpation will be performed in the vagina and requested the maximum voluntary contraction of the pelvic floor muscles.

Check for modification on Perineometry

Time Frame: two months

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 Outcomes

  • Pelvic Floor Distress Inventory (PFDI-20)(two months)
  • International Consultation on Incontinence Questionnaire Short Form(two months)
  • Pelvic Floor Impact Questionnaire (PFIQ-7) Floor Impact Questionnaire (PFIQ-7)(two months)
  • Void diary(two months)

Investigators

Sponsor
Federal University of Uberlandia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Luciene Aparecida José Vaz

Principal Investigator

Federal University of Uberlandia

Study Sites (2)

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