Pelvic Floor Consciousness in Women With Pelvic Floor Dysfunction

Pelvic Floor Disorders Clinical Trial

— PFMCON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334798
• Other study ID #: OE14/2020
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Other:
• Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback
See information included in arm/group descriptions.
• Active exercises of the pelvic floor muscles & Biofeedback
See information included in arm/group descriptions.
• Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback
See information included in arm/group descriptions.
• Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback
See information included in arm/group descriptions.

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.