Pelvic Organ ProlapseNCT01196598
Pelvic Floor Muscle Training and Hypopressive Exercises for Pelvic Organ Prolapse
A study testing Exercises in people with Pelvic Organ Prolapse, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
To verify if pelvic floor muscle training program and/or a hypopressive exercise program could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor muscle strength. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Jan 2011
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with stage II of pelvic organ prolapse, preferably symptomatic and not to be submitted to surgery to correct pelvic organ prolapse during the study
Who cannot join
- Neuromuscular diseases and use of hormonal therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pelvic Floor Muscle Training and Hypopressive Exercises in Women With Pelvic Organ Prolapse: Randomized Controlled Trial
To verify if pelvic floor muscle training program and/or a hypopressive exercise program could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor muscle strength.
Read the detailed description
To verify if three months of an exercise program could improve stage II of pelvic organ prolapse, as a conservative treatment.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Exercises
- Keywords
- pelvic floor, pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Three individual initial sessions for learn about pelvic floor muscle localization and function; receive lifestyle advice and practice the exercises correctly.
The control group receive only lifestyle advice.
Followed by three months of home training with appointments each two weeks with physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| PFMT group | Active comparator | Women who undergo to three months of a pelvic floor muscle training program. Receives: Other: Exercises |
| HE + PFM group | Active comparator | Women who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program. Receives: Other: Exercises |
| HE group | Active comparator | Women who undergo to three months of a hypopressive exercises program. Receives: Other: Exercises |
| Control | Active comparator | Women who undergo to a session for lifestyle advice. Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle changes
Digital palpation - Evaluates the pelvic floor muscle contraction and assign values according to scales: Oxford (previously validated) and muscular endurance (measured in seconds)
Surface electromyography - evaluates the electrical activity generated by activation of motor units of pelvic floor muscles - during the rest and during the maximum voluntary contraction
2D perineal ultrasound - evaluates the cross sectional area of levator ani muscle.
Measured: 3 months after the begining of treatment
Secondary outcomes (1)
Pelvic Organ Prolapse changes
Quantification of stage of pelvic organ prolapse. Measured during gynecology exam by pelvic organ prolapse quantification (POP-Q)exam.
Measure of changes in symptoms of pelvic organ prolapse using a questionnaire.
Measured: 3 months after the begining of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startJan 2008
- Primary completionOct 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Ana Paula M. Resende, Principal investigator, Post graduate student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196598
- Sponsor's protocol ID
- 1978/07
- Status last verified
- Aug 2010
- First submitted
- 1 Sep 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.
PubMed 30311680Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9. doi: 10.1590/s1516-31802012000100002.
PubMed 22344353
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pelvic Floor Muscle Training and Hypopressive Exercises in Women With Pelvic Organ Prolapse: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01196598
- Acronym / sponsor ID
- 1978/07
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic floor, pelvic organ prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 8 Sep 2010 (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.
To verify if pelvic floor muscle training program and/or a hypopressive exercise program could improve women with stage II of pelvic organ prolapse, their symptoms or pelvic floor muscle strength.
Detailed description
To verify if three months of an exercise program could improve stage II of pelvic organ prolapse, as a conservative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PFMT group | Active comparator | Other: ExercisesWomen who undergo to three months of a pelvic floor muscle training program. |
| HE + PFM group | Active comparator | Other: ExercisesWomen who undergo to three months of a hypopressive exercises plus pelvic floor muscle contraction program. |
| HE group | Active comparator | Other: ExercisesWomen who undergo to three months of a hypopressive exercises program. |
| Control | Active comparator | Other: ExercisesWomen who undergo to a session for lifestyle advice. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with stage II of pelvic organ prolapse, preferably symptomatic and not to be submitted to surgery to correct pelvic organ prolapse during the study
Key exclusion criteria (1 listed)
- Neuromuscular diseases and use of hormonal therapy
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 |
|---|---|---|
| ExercisesThree individual initial sessions for learn about pelvic floor muscle localization and function; receive lifestyle advice and practice the exercises correctly. The control group receive only lifestyle advice. Followed by three months of home training with appointments each two weeks with physiotherapist. | Other | Control, HE + PFM group, HE group, PFMT group |
Primary outcome
Pelvic floor muscle changes
Time frame: 3 months after the begining of treatment
Digital palpation - Evaluates the pelvic floor muscle contraction and assign values according to scales: Oxford (previously validated) and muscular endurance (measured in seconds) Surface electromyography - evaluates the electrical activity generated by activation of motor units of pelvic floor muscles - during the rest and during the maximum voluntary contraction 2D perineal ultrasound - evaluates the cross sectional area of levator ani muscle.
1 secondary outcome
Pelvic Organ Prolapse changes
Time frame: 3 months after the begining of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Derived from this study: PubMed 30311680Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.
- Derived from this study: PubMed 22344353Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9. doi: 10.1590/s1516-31802012000100002.
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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.
Ana Paula M. Resende principal investigator
Post graduate student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Pelvic Organ Prolapse, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Sep 2010. 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 Brazil. 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?
Results are not available in the source record.
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?
Pelvic floor muscle changes (time frame: 3 months after the begining of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01196598, which also lists 2 linked publications.
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 Sep 2010.