Pelvic Floor DisordersHEPFDNCT02259712
Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy
A study testing Hypopressive exercises, Therapeutic education. and Pelvic-perineal physiotherapy in people with Pelvic Floor Disorders and Urinary Incontinence, run by University of Alcala at 1 site in Spain.
Trial summary
Introduction: Hypopressive Exercises are included within a method of physiotherapy which was created with the purpose of strengthening the deep muscles of the abdomen without damaging ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic floor reflexively. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Pelvic Floor Disorders, Urinary Incontinence, Fecal Incontinence
- What is being tested?
- Hypopressive exercises, Therapeutic education. and Pelvic-perineal physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who experience signs and symptoms evidencing pelvic floor dysfunction.
- Women with a medical diagnosis of pelvic floor dysfunction.
- Women with signs and or symptoms of urinary incontinence, anal incontinence, overactive bladder syndrome and prolapse in grade I-II.
- All participants must understand and sign freely Informed Consent.
Who cannot join
- Women minors.
- Pregnant women.
- Women who have had a vaginal delivery or cesarean in the past six months.
- Women with pelvic floor dysfunction which is serious and the first indication is surgical (prolapses grades III-IV).
- Women who have been treated for perineal physiotherapy in the past 12 months.
- Participants submit any pathology that may affect treatment (neurological, gynecological or urological), or recurrent urinary tract infection or hematuria.
- Women with cognitive limitations in understanding the information, respond to questionnaires, consent and / or participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
Alcalá de Henares, Madrid, 28871
About this study
Official title: Effectiveness of Hypopressive Exercises Versus Pelvic- Perineal Physiotherapy in Women With Pelvic Floor Dysfunction: Randomised, Single-blinded, Clinical Trial.
Introduction: Hypopressive Exercises are included within a method of physiotherapy which was created with the purpose of strengthening the deep muscles of the abdomen without damaging ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic floor reflexively. Although this technique has been included as treatment and a prevention method of pelvic floor dysfunction, there are few studies supporting its benefits. The investigators hypothesis is that the combination of both physiotherapy treatments will provided the best results for women who suffer pelvic floor dysfunctions.
Objective: To determine whether Hypopressive Exercises are an option to include in the physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the results reported are comparable to those provided by pelvic-perineal physiotherapy.
Read more
Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups:
- An experimental group, where the participants will be treated by Hypopressive exercises and hygienic and behavioral measures;
- Another experimental group where pelvic-perineal physiotherapy will join with Hypopressive exercises and hygienic and behavioral advises;
- And a third group where will be done pelvic-perineal physiotherapy and hygienic and behavioral measures.
Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made. The selection criteria will be: adult women who present signs and symptoms that indicate a pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must understand and sign freely Informed Consent.
Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 26 subjects were required in each group to detect a difference equal to or greater than 3 microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).
Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.
- Being tested
- Hypopressive exercises, Therapeutic education., Pelvic-perineal physiotherapy, Physical Therapy assessment
- Keywords
- Women, Pelvic floor disorders, Urinary incontinence, Fecal incontinence, Physical Therapy Modalities
- Medical subject headings
- Pelvic Floor Disorders, Urinary Incontinence, Fecal Incontinence, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypopressive exercisesOther
Also called Hypopressive kinesiotherapy
45 minutes treatment by hipopressive exercises 2 times per week during 8 weeks. They will be doing in different positions: standing, kneeling, sitting and lying. The patient will be teach a total of 30 exercises. In the week number 8 the women with the physical therapist will choose 3 exercises that will be done daily at home during 20 minutes.
Therapeutic education.Behavioural
Also called Hygienic and behavioral advises.
The therapeutic education will be doing during the 8 weeks of treatment. In the first day the knowledge and the briefs of the pelvic floor dysfunction will be assessed. Dietary and behavioral habits will also be discussed. In the second day anatomical and physiological explanation of the pelvic girdle will be the priority. In the third day will be explained the signs and symptoms of the different pelvic floor dysfunctions. In the four day will be analyzed the risk factors that may cause or worsen pelvic floor dysfunctions.
In the fifth day will be begun to correct the bad habits. In the last day will be reviewed the knowledge and new habits acquired during the treatment. In all treatment days will be discussed the doubts of the participant.
Pelvic-perineal physiotherapyOther
Also called Specific physical therapy.
45 minutes physical therapy treatment 2 times per week during 8 weeks. There will be done specific exercises of the pelvic floor muscles and coordination exercises of the pelvic floor muscles with other muscles in different positions. Electrostimulation, biofeedbak, cones and dinamometric devices can be employed to improve the muscle performance.
Physical Therapy assessmentOther
Also called Physiotherapy evaluation
Pre-treatment, post-treatment, 3, 6 and 12 months after physical therapy treatment. Will be done a specific evaluation of pelvic floor muscles using the Modified Oxford Scale, superficial electromyography, perineometry and dynamometer. For the evaluation of the impact, the signs and the symptoms questionnaires will be completed by the participants.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic-perineal physiotherapy | Active comparator | The treatment duration is 2 days per week during 8 weks (two months). The aproximate duration of the season is 45 minutes. The protocol consists in:
1. Anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity).
2. Hygienic and behavioral advises preventing pelvic floor dysfunctions.
3. Awareness of the pelvic floor muscles.
4. Strengthening the pelvic floor muscles and the entire abdominal pelvic cavity. Use of electrostimulation and biofeedback in different positions if deemed necessary.
5. Treatment the abdominal-pelvic cavity pain if it requires. Receives: Behavioral: Therapeutic education.; Other: Pelvic-perineal physiotherapy; Other: Physical Therapy assessment |
| Hyporessive and Pelvic-perineal PT | Experimental | The treatment duration is 2 days per week, 8 weeks (two months). The session is about 45 minutes. All women are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle. The participants are also treated by doing Hypopressive exercises and by specific physiotherapy for the strengthening the pelvic floor muscles. Receives: Other: Hypopressive exercises; Behavioral: Therapeutic education.; Other: Pelvic-perineal physiotherapy; Other: Physical Therapy assessment |
| Hypopressive exercises | Experimental | The treatment is done 2 times per week for 8 weeks (2 months). The session duration is about 45 minutes. All participants are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). The participants are also treated by doing Hypopressive exercises in standing, sitting, and supine fours. Receives: Other: Hypopressive exercises; Behavioral: Therapeutic education.; Other: Physical Therapy assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
- Improve the impact of pelvic floor dysfunctions by 30% according to Spanish short version of Pelvic Floor Impact Questionnaire (PFIQ-7).
Measured: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
- Improve the signs and symptoms of pelvic floor dysfunction by 30% according to Spanish short version of Pelvic Floor Distress Inventory (PFDI-20).
Measured: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Secondary outcomes (2)
The change of pelvic floor muscles strenght
- Improve the strength of the pelvic floor muscles by 2 points according to the Modified Oxford Scale.
Measured: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
The change of pelvic floor muscles pressure force
- Improve the strength of pelvic floor in 10 cm H2O measured with digital perineometer.
Measured: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2017
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Navarro Brazález, University of Alcala
- Investigators
- Beatriz N Navarro, PhD student, Principal investigator, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259712
- Sponsor's protocol ID
- OE 20/2013
- Other IDs
- OE 20/2013
- Acronym
- HEPFD
- Status last verified
- Dec 2023
- First submitted
- 5 Sep 2014
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hypopressive Exercises Versus Pelvic- Perineal Physiotherapy in Women With Pelvic Floor Dysfunction: Randomised, Single-blinded, Clinical Trial.
- ClinicalTrials.gov ID
- NCT02259712
- Acronym / sponsor ID
- HEPFD / OE 20/2013
- Keywords
- Women, Pelvic floor disorders, Urinary incontinence, Fecal incontinence, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Hypopressive Exercises are included within a method of physiotherapy which was created with the purpose of strengthening the deep muscles of the abdomen without damaging ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic floor reflexively. Although this technique has been included as treatment and a prevention method of pelvic floor dysfunction, there are few studies supporting its benefits. The investigators hypothesis is that the combination of both physiotherapy treatments will provided the best results for women who suffer pelvic floor dysfunctions.
Objective: To determine whether Hypopressive Exercises are an option to include in the physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the results reported are comparable to those provided by pelvic-perineal physiotherapy.
Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups:
- An experimental group, where the participants will be treated by Hypopressive exercises and hygienic and behavioral measures;
- Another experimental group where pelvic-perineal physiotherapy will join with Hypopressive exercises and hygienic and behavioral advises;
- And a third group where will be done pelvic-perineal physiotherapy and hygienic and behavioral measures.
Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made. The selection criteria will be: adult women who present signs and symptoms that indicate a pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must understand and sign freely Informed Consent.
Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 26 subjects were required in each group to detect a difference equal to or greater than 3 microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).
Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pelvic-perineal physiotherapy | Active comparator | Behavioral: Therapeutic education., Other: Pelvic-perineal physiotherapy, Other: Physical Therapy assessmentThe treatment duration is 2 days per week during 8 weks (two months). The aproximate duration of the season is 45 minutes. The protocol consists in: 1. Anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). 2. Hygienic and behavioral advises preventing pelvic floor dysfunctions. 3. Awareness of the pelvic floor muscles. 4. Strengthening the pelvic floor muscles and the entire abdominal pelvic cavity. Use of electrostimulation and biofeedback in different positions if deemed necessary. 5. Treatment the abdominal-pelvic cavity pain if it requires. |
| Hyporessive and Pelvic-perineal PT | Experimental | Other: Hypopressive exercises, Behavioral: Therapeutic education., Other: Pelvic-perineal physiotherapy, Other: Physical Therapy assessmentThe treatment duration is 2 days per week, 8 weeks (two months). The session is about 45 minutes. All women are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle. The participants are also treated by doing Hypopressive exercises and by specific physiotherapy for the strengthening the pelvic floor muscles. |
| Hypopressive exercises | Experimental | Other: Hypopressive exercises, Behavioral: Therapeutic education., Other: Physical Therapy assessmentThe treatment is done 2 times per week for 8 weeks (2 months). The session duration is about 45 minutes. All participants are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). The participants are also treated by doing Hypopressive exercises in standing, sitting, and supine fours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women who experience signs and symptoms evidencing pelvic floor dysfunction.
- Women with a medical diagnosis of pelvic floor dysfunction.
- Women with signs and or symptoms of urinary incontinence, anal incontinence, overactive bladder syndrome and prolapse in grade I-II.
- All participants must understand and sign freely Informed Consent.
Key exclusion criteria (7 listed)
- Women minors.
- Pregnant women.
- Women who have had a vaginal delivery or cesarean in the past six months.
- Women with pelvic floor dysfunction which is serious and the first indication is surgical (prolapses grades III-IV).
- Women who have been treated for perineal physiotherapy in the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypopressive exercisesAlso: Hypopressive kinesiotherapy45 minutes treatment by hipopressive exercises 2 times per week during 8 weeks. They will be doing in different positions: standing, kneeling, sitting and lying. The patient will be teach a total of 30 exercises. In the week number 8 the women with the physical therapist will choose 3 exercises that will be done daily at home during 20 minutes. | Other | Hypopressive exercises, Hyporessive and Pelvic-perineal PT |
| Therapeutic education.Also: Hygienic and behavioral advises.The therapeutic education will be doing during the 8 weeks of treatment. In the first day the knowledge and the briefs of the pelvic floor dysfunction will be assessed. Dietary and behavioral habits will also be discussed. In the second day anatomical and physiological explanation of the pelvic girdle will be the priority. In the third day will be explained the signs and symptoms of the different pelvic floor dysfunctions. In the four day will be analyzed the risk factors that may cause or worsen pelvic floor dysfunctions. In the fifth day will be begun to correct the bad habits. In the last day will be reviewed the knowledge and new habits acquired during the treatment. In all treatment days will be discussed the doubts of the participant. | Behavioural | Hypopressive exercises, Hyporessive and Pelvic-perineal PT, Pelvic-perineal physiotherapy |
| Pelvic-perineal physiotherapyAlso: Specific physical therapy.45 minutes physical therapy treatment 2 times per week during 8 weeks. There will be done specific exercises of the pelvic floor muscles and coordination exercises of the pelvic floor muscles with other muscles in different positions. Electrostimulation, biofeedbak, cones and dinamometric devices can be employed to improve the muscle performance. | Other | Hyporessive and Pelvic-perineal PT, Pelvic-perineal physiotherapy |
| Physical Therapy assessmentAlso: Physiotherapy evaluationPre-treatment, post-treatment, 3, 6 and 12 months after physical therapy treatment. Will be done a specific evaluation of pelvic floor muscles using the Modified Oxford Scale, superficial electromyography, perineometry and dynamometer. For the evaluation of the impact, the signs and the symptoms questionnaires will be completed by the participants. | Other | Hypopressive exercises, Hyporessive and Pelvic-perineal PT, Pelvic-perineal physiotherapy |
Primary outcome
The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
Time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
- Improve the impact of pelvic floor dysfunctions by 30% according to Spanish short version of Pelvic Floor Impact Questionnaire (PFIQ-7).
The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
Time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
- Improve the signs and symptoms of pelvic floor dysfunction by 30% according to Spanish short version of Pelvic Floor Distress Inventory (PFDI-20).
2 secondary outcomes
The change of pelvic floor muscles strenght
Time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
The change of pelvic floor muscles pressure force
Time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Women's Health Research Group InfoLink provided by the sponsor.
Related trials for Pelvic Floor Disorders
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz N Navarro, PhD student principal investigator
University of Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypopressive exercises, Therapeutic education. and Pelvic-perineal physiotherapy in people with Pelvic Floor Disorders and Urinary Incontinence, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of signs, symptoms and impact of pelvic floor dysfunction between reviews (time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.