NCT03203798

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2017

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

25 days

First QC Date

June 26, 2017

Last Update Submit

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 COMPARATOR
Procedure: Training of pelvic floor muscles

Hipopressive abdominal gymnastics

EXPERIMENTAL
Procedure: Hipopressive abdominal gymnastics

Interventions

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.

Training of pelvic floor muscles

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.

Hipopressive abdominal gymnastics

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luciene Aparecida Vaz

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

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

Locations