PFMCON: Pelvic Floor Consciousness

Sponsor

University of Alcala (Other)

Overall Status

Unknown status

CT.gov ID

NCT04334798

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders	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 & Transabdominal US Biofeedback Other: Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2019

Anticipated Primary Completion Date :

Oct 20, 2021

Anticipated Study Completion Date :

Dec 10, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Change in pelvic floor muscle strength [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 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 [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 measured by dynamometry (measured in GRAMS).
Change in pelvic floor muscle passive tone [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 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: at 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physiotherapy in women´s health research group. University of Alcalà	Alcalà de Henares	Madrid	Spain	28871
2	María Torres-Lacomba	Alcalá de Henares	Madrid	Spain	28005
3	University of Alcalá. FPSM research group. HUPA	Alcalá de Henares	Madrid	Spain	28805