Pelvic Floor DisordersHIPOSPFDNCT04336150
Pelvic Floor Muscle Contraction During Hypopressive Exercise in Women With Pelvic Floor Dysfunction
A study testing Hypopressive exercises, Hypopressive maneuver and Hypopressive exercises plus pelvic floor muscle contraction in people with Pelvic Floor Disorders, run by University of Alcala at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Hypopressive exercises, Hypopressive maneuver and Hypopressive exercises plus pelvic floor muscle contraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2019to 10 Dec 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women diagnosed with pelvic floor dysfunction by their doctor.
- With minimum strength of the pelvic floor muscles of 3 according to Modified Oxford Score
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Voluntary Pelvic Floor Muscle Contraction During Different Modalities of Hypopressive Exercise in Women With Pelvic Floor Dysfunction: A Randomized Controlled Trial
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.
Read the detailed description
This is a four-arm, parallel-group randomized controlled trial conducted in women with pelvic floor dysfunction. Participants are randomly allocated to one of four intervention groups combining different components of hypopressive exercise: the hypopressive manoeuvre performed within the specific postural programme traditionally used in hypopressive exercise, with or without voluntary pelvic floor muscle contraction; or the hypopressive manoeuvre performed without the specific postural programme, with or without voluntary pelvic floor muscle contraction.
All interventions are delivered individually under physiotherapist supervision and include an educational component addressing the anatomy and physiology of the abdominopelvic cavity and pelvic floor, together with hygienic and behavioural recommendations for the prevention and management of pelvic floor dysfunction.
The hypopressive manoeuvre consists of expiration followed by expiratory apnoea and active rib-cage expansion without inhalation, accompanied by inward and cranial displacement of the abdominal wall. In the groups using the specific hypopressive postural programme, the manoeuvre is incorporated into a sequence of postures performed in different body positions according to the principles of Hypopressive Abdominal Gymnastics.
In the groups performing the hypopressive manoeuvre without the specific postural programme, real-time transabdominal ultrasound imaging is used as visual biofeedback to facilitate motor learning and contraction of the transversus abdominis muscle during performance of the manoeuvre.
Interventions are performed twice weekly in individually supervised 45-minute sessions. Participants following the specific hypopressive postural programme receive 16 sessions over 8 weeks, whereas participants performing the hypopressive manoeuvre without the specific postural programme receive 12 sessions over 6 weeks.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Hypopressive exercises, Hypopressive maneuver, Hypopressive exercises plus pelvic floor muscle contraction, Hypopressive maneuver plus pelvic floor muscle contraction
- Keywords
- Hypopressive exercises, Pelvic floor muscle trianing, Ultrasound, Active pelvic floor muscle contraction
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypopressive exercisesOther
See information included in arm/group descriptions.
Hypopressive maneuverOther
See information included in arm/group descriptions.
Hypopressive exercises plus pelvic floor muscle contractionOther
See information included in arm/group descriptions.
Hypopressive maneuver plus pelvic floor muscle contractionOther
See information included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Hypopressive exercises | Experimental | Hypopressive exercises described according to Dr. Caufriez
1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
2. Hypopressive exercises according to the original method described by Dr. Caufriez, which is based on performing the hypopressive maneuver in 33 postures that he described (1,2). Receives: Other: Hypopressive exercises |
| Hypopressive exercises&PFM contraction | Experimental | Hypopressive exercises + active pelvic floor muscle contraction:
1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
2. Hypopressive exercises according to the original method described by Dr.Caufriez, which is based on performing the hypopressive maneuver in 33 postures he described, plus the active contraction of the pelvic floor muscles (PFM) during the hypopressive maneuver. Receives: Other: Hypopressive exercises plus pelvic floor muscle contraction |
| Hypopressive maneuver | Experimental | Hypopressive maneuver:
1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
2. Hypopressive maneuver with transabdominal ultrasound biofeedback. Receives: Other: Hypopressive maneuver |
| Hypopressive maneuver&PFM contraction | Experimental | Hypopressive maneuver + pelvic floor muscles contraction:
1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity).
2. Hypopressive maneuver plus active contraction of the pelvic floor muscles with transabdominal ultrasound biofeedback. Receives: Other: Hypopressive maneuver plus pelvic floor muscle contraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in life impact of pelvic floor dysfunction
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).
Measured: 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.
Change in symptoms and quality of life: PFDI-20
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.
Measured: 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.
Secondary outcomes (2)
Change in pelvic floor muscle strength by dinamometry
It will be measured by dynamometry (measured in GRAMS).
Measured: 4 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months and 6 months after the intervention.
Change in pelvic floor muscle pasive tone
It will be measured by dinamometry (measured in GRAMS)
Measured: 4 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months and 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start10 Feb 2019
- Primary completion20 Dec 2024
- Study completion10 Dec 2025
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Torres Lacomba, University of Alcala
- Investigators
- María Torres-Lacomba, PhD, Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336150
- Sponsor's protocol ID
- OE13/2017
- Acronym
- HIPOSPFD
- Status last verified
- Jan 2024
- First submitted
- 31 Mar 2020
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Voluntary Pelvic Floor Muscle Contraction During Different Modalities of Hypopressive Exercise in Women With Pelvic Floor Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04336150
- Acronym / sponsor ID
- HIPOSPFD / OE13/2017
- Conditions
- Pelvic Floor Disorders
- Keywords
- Hypopressive exercises, Pelvic floor muscle trianing, Ultrasound, Active pelvic floor muscle contraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 7 Apr 2020 (actual)
- 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.
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.
Detailed description
This is a four-arm, parallel-group randomized controlled trial conducted in women with pelvic floor dysfunction. Participants are randomly allocated to one of four intervention groups combining different components of hypopressive exercise: the hypopressive manoeuvre performed within the specific postural programme traditionally used in hypopressive exercise, with or without voluntary pelvic floor muscle contraction; or the hypopressive manoeuvre performed without the specific postural programme, with or without voluntary pelvic floor muscle contraction.
All interventions are delivered individually under physiotherapist supervision and include an educational component addressing the anatomy and physiology of the abdominopelvic cavity and pelvic floor, together with hygienic and behavioural recommendations for the prevention and management of pelvic floor dysfunction.
The hypopressive manoeuvre consists of expiration followed by expiratory apnoea and active rib-cage expansion without inhalation, accompanied by inward and cranial displacement of the abdominal wall. In the groups using the specific hypopressive postural programme, the manoeuvre is incorporated into a sequence of postures performed in different body positions according to the principles of Hypopressive Abdominal Gymnastics.
In the groups performing the hypopressive manoeuvre without the specific postural programme, real-time transabdominal ultrasound imaging is used as visual biofeedback to facilitate motor learning and contraction of the transversus abdominis muscle during performance of the manoeuvre.
Interventions are performed twice weekly in individually supervised 45-minute sessions. Participants following the specific hypopressive postural programme receive 16 sessions over 8 weeks, whereas participants performing the hypopressive manoeuvre without the specific postural programme receive 12 sessions over 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypopressive exercises | Experimental | Other: Hypopressive exercisesHypopressive exercises described according to Dr. Caufriez 1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity). 2. Hypopressive exercises according to the original method described by Dr. Caufriez, which is based on performing the hypopressive maneuver in 33 postures that he described (1,2). |
| Hypopressive exercises&PFM contraction | Experimental | Other: Hypopressive exercises plus pelvic floor muscle contractionHypopressive exercises + active pelvic floor muscle contraction: 1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity). 2. Hypopressive exercises according to the original method described by Dr.Caufriez, which is based on performing the hypopressive maneuver in 33 postures he described, plus the active contraction of the pelvic floor muscles (PFM) during the hypopressive maneuver. |
| Hypopressive maneuver | Experimental | Other: Hypopressive maneuverHypopressive maneuver: 1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity). 2. Hypopressive maneuver with transabdominal ultrasound biofeedback. |
| Hypopressive maneuver&PFM contraction | Experimental | Other: Hypopressive maneuver plus pelvic floor muscle contractionHypopressive maneuver + pelvic floor muscles contraction: 1. Anatomical and physiological explanation of the abdomen-pelvic cavity (perineal organs, bone, ligament and muscle structures of the entire abdomen-pelvic cavity). 2. Hypopressive maneuver plus active contraction of the pelvic floor muscles with transabdominal ultrasound biofeedback. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women diagnosed with pelvic floor dysfunction by their doctor.
- With minimum strength of the pelvic floor muscles of 3 according to Modified Oxford Score
Key exclusion criteria (8 listed)
- 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.
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 exercisesSee information included in arm/group descriptions. | Other | Hypopressive exercises |
| Hypopressive maneuverSee information included in arm/group descriptions. | Other | Hypopressive maneuver |
| Hypopressive exercises plus pelvic floor muscle contractionSee information included in arm/group descriptions. | Other | Hypopressive exercises&PFM contraction |
| Hypopressive maneuver plus pelvic floor muscle contractionSee information included in arm/group descriptions. | Other | Hypopressive maneuver&PFM contraction |
Primary outcome
Change in life impact of pelvic floor dysfunction
Time frame: 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.
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: 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.
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.
2 secondary outcomes
Change in pelvic floor muscle strength by dinamometry
Time frame: 4 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months and 6 months after the intervention.
Change in pelvic floor muscle pasive tone
Time frame: 4 assessments to evaluate change from baseline after the intervention period (2 months from baseline), 3 months and 6 months after the intervention.
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 14 Aug 2026.
- Individual participant dataSharing planned: No
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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.
María Torres-Lacomba, PhD principal investigator
University of Alcalá
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, Hypopressive maneuver and Hypopressive exercises plus pelvic floor muscle contraction in people with Pelvic Floor Disorders, 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 2 inclusion and 8 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 14 Aug 2026. 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?
Change in life impact of pelvic floor dysfunction (time frame: 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.). 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 14 Aug 2026.