Effectiveness of Different Hypopressive Exercises in Pelvic Floor Dysfunction

NCT04336150 | Completed

• 1 other identifier: OE13/2017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Floor Disorders

Keywords

Hypopressive exercises; Pelvic floor muscle trianing; Ultrasound

Outcome Measures

Primary Outcomes (2)

• Change in life impact of pelvic floor dysfunction

  It will be assessed by the PFIQ-7 Spanish version. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).

  5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

• Change in symptoms and quality of life: PFDI-20

  It will be assessed by PFDI-20 that is both a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse quality of life. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.

  5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

Secondary Outcomes (4)

• Change in pelvic floor muscle strength by manual scale

  5 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

• Change in pelvic floor muscle strength by dinamometry

  5 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

• Change in pelvic floor muscle pasive tone

  5 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

• Cahnge in the displacement of the base of the bladder during voluntary contraction of the pelvic floor

  5 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.

Study Arms (4)

Hypopressive exercisesE

EXPERIMENTAL

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).

Other: Hypopressive exercises

Hypopressive exercises&PFM contraction

EXPERIMENTAL

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.

Other: Hypopressive exercises plus pelvic floor muscle contraction

Hypopressive maneuver

EXPERIMENTAL

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.

Other: Hypopressive maneuver

Hypopressive maneuver&PFM contraction

EXPERIMENTAL

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.

Other: Hypopressive maneuver plus pelvic floor muscle contraction

Interventions

Hypopressive exercises OTHER

See information included in arm/group descriptions.

Hypopressive exercisesE

Hypopressive maneuver OTHER

See information included in arm/group descriptions.

Hypopressive maneuver

Hypopressive exercises plus pelvic floor muscle contraction OTHER

See information included in arm/group descriptions.

Hypopressive exercises&PFM contraction

Hypopressive maneuver plus pelvic floor muscle contraction OTHER

See information included in arm/group descriptions.

Hypopressive maneuver&PFM contraction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

María

Alcalá de Henares, Madrid, 28005, Spain

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• María Torres-Lacomba, PhD

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator & Professor

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 7, 2020
• Study Start: February 10, 2019
• Primary Completion: December 20, 2021
• Study Completion: April 10, 2022
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)