Pelvic Floor Muscle SyndromePhase 2/3NCT01585090
Effect of Ankle Position and Pelvic Floor Muscle Force With Relaxation of Pelvic Floor Muscles Syndrome
A Phase 2/3 study testing doing strengthening exercises of pelvic floor muscles in people with Pelvic Floor Muscle Syndrome, run by Mashhad University of Medical Sciences.
Trial summary
Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female pelvic floor dysfunction. Actually the best position to facilitate PFM force is controversial in different studies. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Pelvic Floor Muscle Syndrome
- What is being tested?
- doing strengthening exercises of pelvic floor muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 25 to 55 years
- Women only
- Adult
Who may be able to join
- age 25-55
- bma 20-30
- women with relaxation of pelvic floor muscles syndrome in ph.ex and inspection
Who cannot join
- severe deformity in knee joint and ankle
- regular exercise or yoga
- severe or moderate vaginal atrophy
About this study
Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female pelvic floor dysfunction. Actually the best position to facilitate PFM force is controversial in different studies. The aim of this study is to assess the effect of ankle positions on pelvic floor muscle force during PFM exercises.
This clinical trial study was carried out on 58 women aged 25-55 years with relaxation of pelvic floor muscles who referred to women's clinic of educational hospitals of Mashhad University of Medical Sciences in 1389. After clinical examination and confirmation of pelvic floor muscle relaxation, women were randomize divided into 3 groups, doing strengthening exercises of PFM in standing position with passive ankle dorsi flexion (on wooden surface with 15 degree angle)(n=20), active ankle plantar flexion with arm up (standing on toe)(n=20) and horizontal standing position (n=19) for 8 weeks. PFM exercises were instructed to women by using a pamphlet and face to face education. They were followed up every two week by telephone call and were asked to refer to women's clinic after 4 \& 8 weeks. Pelvic floor muscles strength was assessed with brink score before and after intervention. Data analyzed by using analytic-descriptive statistics.
- Conditions
- Pelvic Floor Muscle Syndrome
- Being tested
- doing strengthening exercises of pelvic floor muscles
- Keywords
- Ankle positions, pelvic floor muscles strength, relaxation of pelvic floor muscles syndrome, doing strengthening exercises of pelvic floor muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doing strengthening exercises of pelvic floor musclesOther
| Study group | Role | What they receive |
|---|---|---|
| passive ankle dorsi flexion | Experimental | doing strengthening exercises of PFM in standing position with passive ankle dorsi flexion (on wooden surface with 15 degree angle) Receives: Other: doing strengthening exercises of pelvic floor muscles |
| active ankle plantar flexion with arm up | Experimental | doing strengthening exercises of PFM in standing position with active ankle plantar flexion with arm up (standing on toe)(n=20) and horizontal standing position Receives: Other: doing strengthening exercises of pelvic floor muscles |
| horizontal standing position | No intervention | doing strengthening exercises of PFM in standing position with horizontal standing position Receives: Other: doing strengthening exercises of pelvic floor muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic floor muscles force
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle SyndromeStudies 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 2/3
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nahid golmakani, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585090
- Sponsor's protocol ID
- 89094
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ankle Position and Pelvic Floor Muscle Force With Relaxation of Pelvic Floor Muscles Syndrome
- ClinicalTrials.gov ID
- NCT01585090
- Acronym / sponsor ID
- 89094
- Conditions
- Pelvic Floor Muscle Syndrome
- Keywords
- Ankle positions, pelvic floor muscles strength, relaxation of pelvic floor muscles syndrome, doing strengthening exercises of pelvic floor muscles
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- First posted
- 25 Apr 2012 (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.
Strengthening exercises of Pelvic Floor Muscles (PFM) is the first line treatment for female pelvic floor dysfunction. Actually the best position to facilitate PFM force is controversial in different studies. The aim of this study is to assess the effect of ankle positions on pelvic floor muscle force during PFM exercises.
This clinical trial study was carried out on 58 women aged 25-55 years with relaxation of pelvic floor muscles who referred to women's clinic of educational hospitals of Mashhad University of Medical Sciences in 1389. After clinical examination and confirmation of pelvic floor muscle relaxation, women were randomize divided into 3 groups, doing strengthening exercises of PFM in standing position with passive ankle dorsi flexion (on wooden surface with 15 degree angle)(n=20), active ankle plantar flexion with arm up (standing on toe)(n=20) and horizontal standing position (n=19) for 8 weeks. PFM exercises were instructed to women by using a pamphlet and face to face education. They were followed up every two week by telephone call and were asked to refer to women's clinic after 4 \& 8 weeks. Pelvic floor muscles strength was assessed with brink score before and after intervention. Data analyzed by using analytic-descriptive statistics.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| passive ankle dorsi flexion | Experimental | Other: doing strengthening exercises of pelvic floor musclesdoing strengthening exercises of PFM in standing position with passive ankle dorsi flexion (on wooden surface with 15 degree angle) |
| active ankle plantar flexion with arm up | Experimental | Other: doing strengthening exercises of pelvic floor musclesdoing strengthening exercises of PFM in standing position with active ankle plantar flexion with arm up (standing on toe)(n=20) and horizontal standing position |
| horizontal standing position | No intervention | Other: doing strengthening exercises of pelvic floor musclesdoing strengthening exercises of PFM in standing position with horizontal standing position |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 25-55
- bma 20-30
- women with relaxation of pelvic floor muscles syndrome in ph.ex and inspection
Key exclusion criteria (3 listed)
- severe deformity in knee joint and ankle
- regular exercise or yoga
- severe or moderate vaginal atrophy
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 |
|---|---|---|
| doing strengthening exercises of pelvic floor muscles | Other | active ankle plantar flexion with arm up, horizontal standing position, passive ankle dorsi flexion |
Primary outcome
pelvic floor muscles force
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing doing strengthening exercises of pelvic floor muscles in people with Pelvic Floor Muscle Syndrome, run by Mashhad University of Medical Sciences.
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 3 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: withdrawn, as of the sponsor's last update on 25 Apr 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 muscles force. 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 25 Apr 2012.