Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction

NCT04334798 | Completed

• 1 other identifier: OE14/2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pelvic Floor Disorders

Keywords

Motor Learning; Pelvic Floor Muscles; Physiotherapy; Biofeedback; Consciousness

Outcome Measures

Primary Outcomes (2)

• 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 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 dynamometry

  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

  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

  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)

PFM&electro&BFB

EXPERIMENTAL

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

PFM&BFB

EXPERIMENTAL

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

PFM&electro&transabdominal US

EXPERIMENTAL

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

PFM&transabdominal US

EXPERIMENTAL

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

Interventions

Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback OTHER

See information included in arm/group descriptions.

PFM&electro&BFB

Active exercises of the pelvic floor muscles & Biofeedback OTHER

See information included in arm/group descriptions.

PFM&BFB

Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback OTHER

See information included in arm/group descriptions.

PFM&transabdominal US

Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback OTHER

See information included in arm/group descriptions.

PFM&electro&transabdominal US

Eligibility Criteria

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

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (3)

Physiotherapy in women´s health research group. University of Alcalà

Alcalà de Henares, Madrid, 28871, Spain

Location

María Torres-Lacomba

Alcalá de Henares, Madrid, 28005, Spain

Location

University of Alcalá. FPSM research group. HUPA

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

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: April 2, 2020
• First Posted: April 6, 2020
• Study Start: January 10, 2019
• Primary Completion: October 20, 2021
• Study Completion: December 31, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)