Mild Pelvic Floor DysfunctionUVa_1NCT02212418
Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women
A study testing Abdominal hypopressive technique in people with Mild Pelvic Floor Dysfunction, run by Rafael J. Curbelo.
Trial summary
Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic floor dysfunctions in the postpartum. In the last years it has been extended out of such medical context but there is a lack of scientific evidence, and the endurability of the effects of this technique are unknown. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Mild Pelvic Floor Dysfunction
- What is being tested?
- Abdominal hypopressive technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Aug 2013
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- no systematic participation in sports or physical activities (≤ 3 sessions per week, ≤ 2 weeks per month)
- between 20 and 65 years old
- with availability for three afternoons per week.
Who cannot join
- hypertension
- serious diseases
- pregnancy
- postpartum phase up to 2 months after delivery.
About this study
Official title: Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women: A Randomized Cross-over Trial
Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic floor dysfunctions in the postpartum. In the last years it has been extended out of such medical context but there is a lack of scientific evidence, and the endurability of the effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a 12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary incontinence, in women out of the postpartum phase. In addition the investigators looked for the endurability of its effect.
Methods: The investigators performed a cross-over blinded intervention study of 4 month duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2 months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2 months versus AHT.
The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms, as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired as adequate.
- Conditions
- Mild Pelvic Floor Dysfunction
- Being tested
- Abdominal hypopressive technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal hypopressive techniqueOther
postural technique based on self-elongating, body axis anteriorization, shoulders extension, and maintenance of an expiratory apnea as long as possible
| Study group | Role | What they receive |
|---|---|---|
| Abdominal hypopressive technique | Experimental | Not described Receives: Other: Abdominal hypopressive technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pelvic floor tone at 2 months and after 4 months
Pelvic floor tone was measured by a tonometer (PhoenixTM USB2, France) in a PelvimètreTM, and results are expressed in g/cm2. A physiotherapist specialist in urogynecology did the measurement. This measure was not available for women in their first three days of menstruation or virgins
Measured: at baseline, after 2 months, and after 4 months
Secondary outcomes (1)
change of urinary incontinence at 2 months and after 4 months
Urinary incontinence was measured with the International Consultation on Incontinence Questionnaire - Short Form (ICIQ_SF) . The questionnaire includes three scored items about frequency, severity and perceived impact of incontinence.
Measured: perfomed at baseline, after 2 months, and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Pelvic Floor DysfunctionStudies 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
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafael J. Curbelo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafael J. Curbelo, University of Valladolid
- Investigators
- Lidon Soriano, PhD, Principal investigator, Alfonso X El Sabio UniversityRafael J Curbelo, PhD, Principal investigator, University of ValladolidLoreto Carmona, PhD, Study director, Instituto de Salud Músculo Esquelética
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212418
- Sponsor's protocol ID
- UValladolid_1
- Acronym
- UVa_1
- Status last verified
- Aug 2014
- First submitted
- 2 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women: A Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT02212418
- Acronym / sponsor ID
- UVa_1 / UValladolid_1
- Conditions
- Mild Pelvic Floor Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rafael J. CurbeloUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Aug 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.
Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic floor dysfunctions in the postpartum. In the last years it has been extended out of such medical context but there is a lack of scientific evidence, and the endurability of the effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a 12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary incontinence, in women out of the postpartum phase. In addition the investigators looked for the endurability of its effect.
Methods: The investigators performed a cross-over blinded intervention study of 4 month duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2 months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2 months versus AHT.
The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms, as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired as adequate.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal hypopressive technique | Experimental | Other: Abdominal hypopressive technique |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- no systematic participation in sports or physical activities (≤ 3 sessions per week, ≤ 2 weeks per month)
- between 20 and 65 years old
- with availability for three afternoons per week.
Key exclusion criteria (4 listed)
- hypertension
- serious diseases
- pregnancy
- postpartum phase up to 2 months after delivery.
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 |
|---|---|---|
| Abdominal hypopressive techniquepostural technique based on self-elongating, body axis anteriorization, shoulders extension, and maintenance of an expiratory apnea as long as possible | Other | Abdominal hypopressive technique |
Primary outcome
change of pelvic floor tone at 2 months and after 4 months
Time frame: at baseline, after 2 months, and after 4 months
Pelvic floor tone was measured by a tonometer (PhoenixTM USB2, France) in a PelvimètreTM, and results are expressed in g/cm2. A physiotherapist specialist in urogynecology did the measurement. This measure was not available for women in their first three days of menstruation or virgins
1 secondary outcome
change of urinary incontinence at 2 months and after 4 months
Time frame: perfomed at baseline, after 2 months, and after 4 months
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 8 Aug 2014.
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.
Lidon Soriano, PhD principal investigator
Alfonso X El Sabio University
Rafael J Curbelo, PhD principal investigator
University of Valladolid
Loreto Carmona, PhD study director
Instituto de Salud Músculo Esquelética
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal hypopressive technique in people with Mild Pelvic Floor Dysfunction, run by Rafael J. Curbelo.
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 3 inclusion and 4 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 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 of pelvic floor tone at 2 months and after 4 months (time frame: at baseline, after 2 months, and after 4 months). 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 8 Aug 2014.