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Pelvic Floor Consciousness (PFMCON)

Primary Purpose

Pelvic Floor Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback
Active exercises of the pelvic floor muscles & Biofeedback
Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback
Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring Motor Learning, Pelvic Floor Muscles, Physiotherapy, Biofeedback, Consciousness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women diagnosed with pelvic floor dysfunction by their doctor.
  • 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.

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 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 10 cm, the maximum pain that the participant can imagine.
  • Women who have received pelvic floor physiotherapy treatment in the last 12 months.
  • 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

  • Physiotherapy in women´s health research group. University of AlcalàRecruiting
  • María Torres-LacombaRecruiting
  • University of Alcalá. FPSM research group. HUPARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

PFM&electro&BFB

PFM&BFB

PFM&electro&transabdominal US

PFM&transabdominal US

Arm Description

An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the pelvic floor muscles (PFM) will be performed using intravaginal palpation and electrostimulation, together with biofeedback (BFB).

An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation together with biofeedback (BFB).

An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation and electrostimulation, together with transabdominal ultrasound biofeedback (BFB).

An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation together with transabdominal ultrasound biofeedback (BFB).

Outcomes

Primary Outcome Measures

Change in life impact of pelvic floor dysfunction
It will be assessed by the Pelvic Floor Impact Questionnaire-7 (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
It will be assessed by the Pelvic Floor Distress Inventory-20 (PFDI-20) Spanish version 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 (POP) Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about Urinary Incontinence (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.
Change in pelvic floor muscle strength
It will be measured by dynamometry (measured in GRAMS).
Change in pelvic floor muscle passive tone
It will be measured by dynamometry (measured in GRAMS).
Change in the displacement of the base of the bladder during voluntary contraction of the pelvic floor
It will be measured by Ultrasound

Full Information

First Posted
April 2, 2020
Last Updated
April 3, 2020
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT04334798
Brief Title
Pelvic Floor Consciousness
Acronym
PFMCON
Official Title
Effectiveness of Different Modalities of Motor Learning of Pelvic Floor Muscle Contraction in Women With Pelvic Floor Dysfunction: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
October 20, 2021 (Anticipated)
Study Completion Date
December 10, 2021 (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 ofof motor learning of pelvic floor muscle contraction 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
Motor Learning, Pelvic Floor Muscles, Physiotherapy, Biofeedback, Consciousness

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
PFM&electro&BFB
Arm Type
Experimental
Arm Description
An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the pelvic floor muscles (PFM) will be performed using intravaginal palpation and electrostimulation, together with biofeedback (BFB).
Arm Title
PFM&BFB
Arm Type
Experimental
Arm Description
An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation together with biofeedback (BFB).
Arm Title
PFM&electro&transabdominal US
Arm Type
Experimental
Arm Description
An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation and electrostimulation, together with transabdominal ultrasound biofeedback (BFB).
Arm Title
PFM&transabdominal US
Arm Type
Experimental
Arm Description
An educational program (anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity; knack) will be implemented, and active exercises of the PFM will be performed using intravaginal palpation together with transabdominal ultrasound biofeedback (BFB).
Intervention Type
Other
Intervention Name(s)
Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback
Intervention Description
See information included in arm/group descriptions.
Intervention Type
Other
Intervention Name(s)
Active exercises of the pelvic floor muscles & Biofeedback
Intervention Description
See information included in arm/group descriptions.
Intervention Type
Other
Intervention Name(s)
Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback
Intervention Description
See information included in arm/group descriptions.
Intervention Type
Other
Intervention Name(s)
Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback
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 Pelvic Floor Impact Questionnaire-7 (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
Description
It will be assessed by the Pelvic Floor Distress Inventory-20 (PFDI-20) Spanish version 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 (POP) Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about Urinary Incontinence (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.
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 passive tone
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 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
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. 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. 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 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 10 cm, the maximum pain that the participant can imagine. Women who have received pelvic floor physiotherapy treatment in the last 12 months. 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
+34918854828
Email
maria.torres@uah.es
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz Navarro-Brazález, PhD
Phone
+34678900061
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
Physiotherapy in women´s health research group. University of Alcalà
City
Alcalà de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Torres-Lacomba, PhD
Email
maria.torres@uah.es
Facility Name
María Torres-Lacomba
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
+34678900061
Email
maria.torres@uah.es
First Name & Middle Initial & Last Name & Degree
Beatriz Navarro-Brazález, PhD
Email
b.navarrobrazalez@gmail.com
First Name & Middle Initial & Last Name & Degree
Beatriz Arrainz Martín, MsC
Facility Name
University of Alcalá. FPSM research group. HUPA
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Torres-Lacomba, PhD
Email
maria.torres@uah.es
First Name & Middle Initial & Last Name & Degree
Beatriz Navarro-Brazález, PhD
Email
b.navarrobrazalez@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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