Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction (PFMCON)

Effectiveness of Different Modalities of Motor Learning of Pelvic Floor Muscle Contraction in Women With Pelvic Floor Dysfunction: Randomized Controlled Trial

The purpose of the study is to compare the efficacy of different modalities of 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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Other: Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback; Other: Active exercises of the pelvic floor muscles & Biofeedback; Other: Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback; Other: Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalà de Henares, Madrid, Spain, 28871
      • Physiotherapy in women´s health research group. University of Alcalà
    • Alcalá de Henares, Madrid, Spain, 28805
      • University of Alcalá. FPSM research group. HUPA
    • Alcalá de Henares, Madrid, Spain, 28005
      • María Torres-Lacomba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PFM&electro&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 pelvic floor muscles (PFM) will be performed using intravaginal palpation and electrostimulation, together with biofeedback (BFB).	Other: Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback; See information included in arm/group descriptions.
Experimental: PFM&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).	Other: Active exercises of the pelvic floor muscles & Biofeedback; See information included in arm/group descriptions.
Experimental: PFM&electro&transabdominal US; 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).	Other: Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback; See information included in arm/group descriptions.
Experimental: PFM&transabdominal US; 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).	Other: Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback; See information included in arm/group descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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.	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 Measures

Outcome Measure	Measure Description	Time Frame
Change in pelvic floor muscle strength by manual scale	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.	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 dynamometry	It will be measured by dynamometry (measured in GRAMS).	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 passive tone	It will be measured by dynamometry (measured in GRAMS).	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 the displacement of the base of the bladder during voluntary contraction of the pelvic floor	It will be measured by Ultrasound	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.

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Principal Investigator: María Torres-Lacomba, PhD, University of Alcalá

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Physiotherapy; Biofeedback; Motor Learning; Consciousness; Pelvic Floor Muscles
• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Floor Disorders
• Other Study ID Numbers: OE14/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No