Effectiveness of Different Hypopressive Exercises for Treating Pelvic Floor Dysfunction in Women: Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Floor Disorders
- Sponsor
- University of Alcala
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in life impact of pelvic floor dysfunction
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of the study is to compare the efficacy of different modalities of hypopressive exercises and biofeedback with ultrasound 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
Female 18-65 years old Inclusion Criteria: Women diagnosed with pelvic floor dysfunction by their doctor. With minimum strength of the pelvic floor muscles of 3 according to Modified Oxford Score 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 only urinary incontinence or fecal urgency. 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 10cm, the maximum pain that the participant can imagine. Women who have received pelvic floor physiotherapy treatment in the last 12 months. 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. 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.
Investigators
Maria Torres Lacomba
Principal investigator & Professor
University of Alcala
Eligibility Criteria
Inclusion Criteria
- •Women diagnosed with pelvic floor dysfunction by their doctor.
- •With minimum strength of the pelvic floor muscles of 3 according to Modified Oxford Score
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 only urinary incontinence or fecal urgency.
- •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 10cm, the maximum pain that the participant can imagine.
- •Women who have received pelvic floor physiotherapy treatment in the last 12 months.
- •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
- •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.
Outcomes
Primary Outcomes
Change in life impact of pelvic floor dysfunction
Time Frame: 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 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: PFDI-20
Time Frame: 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 PFDI-20 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 Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.
Secondary Outcomes
- Change in pelvic floor muscle strength by dinamometry(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 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 pasive 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.)
- Cahnge 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.)