Back to resultsEffectiveness of Different Hypopressive Exercises in Pelvic Floor Dysfunction (HIPOSPFD)
Primary Purpose
Pelvic Floor Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hypopressive exercises
Hypopressive maneuver
Hypopressive exercises plus pelvic floor muscle contraction
Hypopressive maneuver plus pelvic floor muscle contraction
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring Hypopressive exercises, Pelvic floor muscle trianing, Ultrasound
Eligibility Criteria
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.
Sites / Locations
- MaríaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Hypopressive exercisesE
Hypopressive exercises&PFM contraction
Hypopressive maneuver
Hypopressive maneuver&PFM contraction
Arm Description
Hypopressive exercises described according to Dr. Caufriez Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity). 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).
Hypopressive exercises + active pelvic floor muscle contraction: Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity). 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.
Hypopressive maneuver: Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity). Hypopressive maneuver with transabdominal ultrasound biofeedback.
Hypopressive maneuver + pelvic floor muscles contraction: Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity). Hypopressive maneuver plus active contraction of the pelvic floor muscles with transabdominal ultrasound biofeedback.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Change in pelvic floor muscle strength
It will be measured by Modified Oxford Scale to rate pelvic floor muscle contraction on a scale of 0-5: 0 = no contraction; 1 = minor muscle; 'flicker'; 2 = weak muscle; contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction. T)
Change in pelvic floor muscle strength
It will be measured by dynamometry (measured in GRAMS).
Change in pelvic floor muscle pasive tone
It will be measured by dinamometry (measured in GRAMS)
Cahnge in the displacement of the base of the bladder during voluntary contraction of the pelvic floor
It will be measured by Ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04336150
Brief Title
Effectiveness of Different Hypopressive Exercises in Pelvic Floor Dysfunction
Acronym
HIPOSPFD
Official Title
Effectiveness of Different Hypopressive Exercises for Treating Pelvic Floor Dysfunction in Women: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
April 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Hypopressive exercises, Pelvic floor muscle trianing, Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypopressive exercisesE
Arm Type
Experimental
Arm Description
Hypopressive exercises described according to Dr. Caufriez
Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
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).
Arm Title
Hypopressive exercises&PFM contraction
Arm Type
Experimental
Arm Description
Hypopressive exercises + active pelvic floor muscle contraction:
Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
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.
Arm Title
Hypopressive maneuver
Arm Type
Experimental
Arm Description
Hypopressive maneuver:
Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
Hypopressive maneuver with transabdominal ultrasound biofeedback.
Arm Title
Hypopressive maneuver&PFM contraction
Arm Type
Experimental
Arm Description
Hypopressive maneuver + pelvic floor muscles contraction:
Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
Hypopressive maneuver plus active contraction of the pelvic floor muscles with transabdominal ultrasound biofeedback.
Intervention Type
Other
Intervention Name(s)
Hypopressive exercises
Intervention Description
See information included in arm/group descriptions.
Intervention Type
Other
Intervention Name(s)
Hypopressive maneuver
Intervention Description
See information included in arm/group descriptions.
Intervention Type
Other
Intervention Name(s)
Hypopressive exercises plus pelvic floor muscle contraction
Intervention Description
See information included in arm/group descriptions.
Intervention Type
Other
Intervention Name(s)
Hypopressive maneuver plus pelvic floor muscle contraction
Intervention Description
See information included in arm/group descriptions.
Primary Outcome Measure Information:
Title
Change in life impact of pelvic floor dysfunction
Description
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).
Time Frame
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.
Title
Change in symptoms and quality of life: PFDI-20
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change in pelvic floor muscle strength
Description
It will be measured by Modified Oxford Scale to rate pelvic floor muscle contraction on a scale of 0-5: 0 = no contraction; 1 = minor muscle; 'flicker'; 2 = weak muscle; contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction. T)
Time Frame
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.
Title
Change in pelvic floor muscle strength
Description
It will be measured by dynamometry (measured in GRAMS).
Time Frame
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.
Title
Change in pelvic floor muscle pasive tone
Description
It will be measured by dinamometry (measured in GRAMS)
Time Frame
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.
Title
Cahnge in the displacement of the base of the bladder during voluntary contraction of the pelvic floor
Description
It will be measured by Ultrasound
Time Frame
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.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Torres-Lacomba, PhD
Phone
918854828
Email
maria.torres@uah.es
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz Navarro-Brazález, PhD
Phone
918854828
Email
b.navarrobrazalez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Torres-Lacomba, PhD
Organizational Affiliation
University of Alcalá
Official's Role
Principal Investigator
Facility Information:
Facility Name
María
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Torres-Lacomba, PhD
Phone
918854828
Email
maria.torres@uah.es
First Name & Middle Initial & Last Name & Degree
Beatriz Navarro-Brazález
Phone
918854828
Email
b.navarrobrazalez@gmail.com
First Name & Middle Initial & Last Name & Degree
Beatriz Arranz-Martín, MsC
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effectiveness of Different Hypopressive Exercises in Pelvic Floor Dysfunction
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