Pelvic Floor Muscle Contraction During Hypopressive Exercise in Women With Pelvic Floor Dysfunction (NCT04336150) | Clinical Trial Compass
CompletedNot Applicable
Pelvic Floor Muscle Contraction During Hypopressive Exercise in Women With Pelvic Floor Dysfunction
Spain80 participantsStarted 2019-02-10
Plain-language summary
The purpose of this randomized controlled trial is to compare the effectiveness of different modalities of hypopressive exercise in women with pelvic floor dysfunction. The study evaluates the effects of performing the hypopressive manoeuvre with or without the specific postural programme traditionally used in hypopressive exercise and with or without the addition of voluntary pelvic floor muscle contraction. Transabdominal ultrasound biofeedback is incorporated into the groups performing the hypopressive manoeuvre without the specific postural programme.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in life impact of pelvic floor dysfunction
Timeframe: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 month and 6 months after the intervention.
2
Change in symptoms and quality of life: PFDI-20
Timeframe: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months and 6 months after the intervention.