Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01763957
• Other study ID #: Paula/PFMT-HMO-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: December 17, 2012
• Last updated: October 10, 2013
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2012
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Quality of Life
• Sexual Satisfaction
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• Paula Method
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)
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 .

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention	No
Secondary	change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID		1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention	No
Secondary	improvement of sexual function	To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI	1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention	No
Secondary	improvement of quality of life	To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI	1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention	No