Stress Urinary IncontinenceNCT01763957
Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence
A study testing Paula Method and Pelvic Floor Muscle Training (PFMT) in people with Stress Urinary Incontinence and Sexual Satisfaction, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Sexual Satisfaction, Quality of Life
- What is being tested?
- Paula Method and Pelvic Floor Muscle Training (PFMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2013to Jun 2015
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women after menopause (12 months with no period)
- aged 40 or more
- have a positive pad test leakage of 1-50 grams
- no systemic or local hormonal therapy
- literate in Hebrew and/or English
Who cannot join
- women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)
- pelvic surgery within the last 6 months
- post hysterectomy or oophorectomy genital prolapse grade 3 or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Circular Muscle Exercise (the Paula Method) as Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence (SUI) in Menopausal Women: A Randomized Controlled Trial
The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.
- Being tested
- Paula Method, Pelvic Floor Muscle Training (PFMT)
- Medical subject headings
- Urinary Incontinence, Stress, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paula MethodBehavioural
All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list.
Pelvic Floor Muscle Training (PFMT)Behavioural
All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list .
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT) | Active comparator | Not described Receives: Behavioral: Pelvic Floor Muscle Training (PFMT) |
| Paula Method | Active comparator | Not described Receives: Behavioral: Paula Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the quantity of urinary leakage, measured by the one hour pad test
To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI
Measured: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
Secondary outcomes (3)
change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID
Measured: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
improvement of sexual function
To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI
Measured: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
improvement of quality of life
To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI
Measured: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drorith Hochner-Celnikier, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763957
- Sponsor's protocol ID
- Paula/PFMT-HMO-CTIL
- Status last verified
- Dec 2012
- First submitted
- 17 Dec 2012
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Circular Muscle Exercise (the Paula Method) as Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence (SUI) in Menopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01763957
- Acronym / sponsor ID
- Paula/PFMT-HMO-CTIL
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 9 Jan 2013 (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.
The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT) | Active comparator | Behavioral: Pelvic Floor Muscle Training (PFMT) |
| Paula Method | Active comparator | Behavioral: Paula Method |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- women after menopause (12 months with no period)
- aged 40 or more
- have a positive pad test leakage of 1-50 grams
- no systemic or local hormonal therapy
- literate in Hebrew and/or English
Key exclusion criteria (3 listed)
- women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders)
- pelvic surgery within the last 6 months
- post hysterectomy or oophorectomy genital prolapse grade 3 or higher
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 |
|---|---|---|
| Paula MethodAll subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list. | Behavioural | Paula Method |
| Pelvic Floor Muscle Training (PFMT)All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list . | Behavioural | Pelvic Floor Muscle Training (PFMT) |
Primary outcome
change in the quantity of urinary leakage, measured by the one hour pad test
Time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI
3 secondary outcomes
change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID
Time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
improvement of sexual function
Time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
improvement of quality of life
Time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention
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 11 Oct 2013.
Related trials for Stress Urinary Incontinence
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, Stress Urinary Incontinence
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
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.
Drorith Hochner-Celnikier, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paula Method and Pelvic Floor Muscle Training (PFMT) in people with Stress Urinary Incontinence and Sexual Satisfaction, run by Hadassah Medical Organization at 1 site in Israel.
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 5 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 11 Oct 2013. 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 Israel. 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 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?
change in the quantity of urinary leakage, measured by the one hour pad test (time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention). 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 11 Oct 2013.