Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction

Not Applicable

Completed

• Conditions: Pelvic Floor Disorders
• Interventions: Other: Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback; Other: Active exercises of the pelvic floor muscles & Biofeedback; Other: Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback; Other: Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback

• Registration Number: NCT04334798
• Lead Sponsor: University of Alcala

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-10
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Primary Completion: 2021-10-20
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFM&transabdominal US	Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback	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).
PFM&BFB	Active exercises of the pelvic floor muscles & Biofeedback	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).
PFM&electro&BFB	Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback	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).
PFM&electro&transabdominal US	Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback	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).

Primary Outcome Measures

Name	Time	Method
Change in life impact of pelvic floor dysfunction	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.	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	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.	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

Name	Time	Method
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.	It will be measured by dynamometry (measured in GRAMS).
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.	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	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.	It will be measured by Ultrasound
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.	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.

Trial Locations

Locations (3)

Physiotherapy in women´s health research group. University of Alcalà; 🇪🇸 Alcalà de Henares, Madrid, Spain

María Torres-Lacomba; 🇪🇸 Alcalá de Henares, Madrid, Spain

University of Alcalá. FPSM research group. HUPA; 🇪🇸 Alcalá de Henares, Madrid, Spain