Pelvic Floor Disorders
Conditions
Keywords
Motor Learning, Pelvic Floor Muscles, Physiotherapy, Biofeedback, Consciousness
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.
Interventions
OTHERActive exercises of the pelvic floor muscles & Electrostimulation & Biofeedback
See information included in arm/group descriptions.
OTHERActive exercises of the pelvic floor muscles & Biofeedback
See information included in arm/group descriptions.
OTHERActive exercises of the pelvic floor muscles & Transabdominal US Biofeedback
See information included in arm/group descriptions.
OTHERActive exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback
See information included in arm/group descriptions.
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 |
Countries
Spain
Outcome results
None listed