Effectiveness of Different Hypopressive Exercises in Pelvic Floor Dysfunction

NCT ID: NCT04336150

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-10

Study Completion Date

2022-04-10

Brief Summary

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The purpose of the study is to compare the efficacy of different modalities of hypopressive exercises and biofeedback with ultrasound in women with pelvic floor dysfunctions, considering the efficacy of the treatment as improving the specific quality of life related to pelvic floor dysfunctions and improvement of the muscular properties of the pelvic floor muscles.

Detailed Description

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Female 18-65 years old

Inclusion Criteria:

Women diagnosed with pelvic floor dysfunction by their doctor. With minimum strength of the pelvic floor muscles of 3 according to Modified Oxford Score

Exclusion Criteria:

Women who are pregnant or women who have had a vaginal or caesarean birth in the past six months.

Women whose PFD is severe and the first indication is surgical (POP-Q grade III-IV prolapses).

Women with only urinary incontinence or fecal urgency. Women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10cm, the maximum pain that the participant can imagine.

Women who have received pelvic floor physiotherapy treatment in the last 12 months.

Women who are unable to voluntarily contract the pelvic floor muscles, quantified by the Modified Oxford Score by a score less than or equal to 2.

Women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria.

Women with cognitive limitations to understand the information, answer the questionnaires, consent and / or participate in the study.

Conditions

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Pelvic Floor Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Hypopressive exercisesE

Hypopressive exercises described according to Dr. Caufriez

1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
2. Hypopressive exercises according to the original method described by Dr. Caufriez, which is based on performing the hypopressive maneuver in 33 postures that he described (1,2).

Group Type EXPERIMENTAL

Hypopressive exercises

Intervention Type OTHER

See information included in arm/group descriptions.

Hypopressive exercises&PFM contraction

Hypopressive exercises + active pelvic floor muscle contraction:

1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
2. Hypopressive exercises according to the original method described by Dr.Caufriez, which is based on performing the hypopressive maneuver in 33 postures he described, plus the active contraction of the pelvic floor muscles (PFM) during the hypopressive maneuver.

Group Type EXPERIMENTAL

Hypopressive exercises plus pelvic floor muscle contraction

Intervention Type OTHER

See information included in arm/group descriptions.

Hypopressive maneuver

Hypopressive maneuver:

1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
2. Hypopressive maneuver with transabdominal ultrasound biofeedback.

Group Type EXPERIMENTAL

Hypopressive maneuver

Intervention Type OTHER

See information included in arm/group descriptions.

Hypopressive maneuver&PFM contraction

Hypopressive maneuver + pelvic floor muscles contraction:

1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
2. Hypopressive maneuver plus active contraction of the pelvic floor muscles with transabdominal ultrasound biofeedback.

Group Type EXPERIMENTAL

Hypopressive maneuver plus pelvic floor muscle contraction

Intervention Type OTHER

See information included in arm/group descriptions.

Interventions

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Hypopressive exercises

See information included in arm/group descriptions.

Intervention Type OTHER

Hypopressive maneuver

See information included in arm/group descriptions.

Intervention Type OTHER

Hypopressive exercises plus pelvic floor muscle contraction

See information included in arm/group descriptions.

Intervention Type OTHER

Hypopressive maneuver plus pelvic floor muscle contraction

See information included in arm/group descriptions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with pelvic floor dysfunction by their doctor.
* With minimum strength of the pelvic floor muscles of 3 according to Modified Oxford Score

Exclusion Criteria

* Women who are pregnant or women who have had a vaginal or caesarean birth in the past six months.
* Women whose PFD is severe and the first indication is surgical (POP-Q grade III-IV prolapses).
* Women with only urinary incontinence or fecal urgency.
* Women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10cm, the maximum pain that the participant can imagine.
* Women who have received pelvic floor physiotherapy treatment in the last 12 months.
* Women who are unable to voluntarily contract the pelvic floor muscles, quantified by the Modified Oxford Score by a score less than or equal to 2.
* Women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria.
* Women with cognitive limitations to understand the information, answer the questionnaires, consent and / or participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Maria Torres Lacomba

Principal investigator & Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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María Torres-Lacomba, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá

Locations

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María

Alcalá de Henares, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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OE13/2017

Identifier Type: -

Identifier Source: org_study_id

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