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Effectiveness of Different Hypopressive Exercises in Pelvic Floor Dysfunction (HIPOSPFD)

U

University of Alcala

Status

Completed

Conditions

Pelvic Floor Disorders

Treatments

Other: Hypopressive exercises
Other: Hypopressive maneuver plus pelvic floor muscle contraction
Other: Hypopressive maneuver
Other: Hypopressive exercises plus pelvic floor muscle contraction

Study type

Interventional

Funder types

Other

Identifiers

NCT04336150
OE13/2017

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 4 patient groups

Hypopressive exercisesE
Experimental group
Description:
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).
Treatment:
Other: Hypopressive exercises
Hypopressive exercises&PFM contraction
Experimental group
Description:
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.
Treatment:
Other: Hypopressive exercises plus pelvic floor muscle contraction
Hypopressive maneuver
Experimental group
Description:
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.
Treatment:
Other: Hypopressive maneuver
Hypopressive maneuver&PFM contraction
Experimental group
Description:
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.
Treatment:
Other: Hypopressive maneuver plus pelvic floor muscle contraction

Trial contacts and locations

1

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Central trial contact

María Torres-Lacomba, PhD; Beatriz Navarro-Brazález, PhD

Data sourced from clinicaltrials.gov

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