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

NCT01763957 | Withdrawn

• 1 other identifier: Paula/PFMT-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Urinary Incontinence; Sexual Satisfaction; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• improvement of sexual function

  1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention

• improvement of quality of life

  1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention

Study Arms (2)

Pelvic Floor Muscle Training (PFMT)

ACTIVE COMPARATOR

Behavioral: Pelvic Floor Muscle Training (PFMT)

Paula Method

ACTIVE COMPARATOR

Behavioral: Paula Method

Interventions

Paula Method BEHAVIORAL

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.

Paula Method

Pelvic Floor Muscle Training (PFMT) BEHAVIORAL

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)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Orgasm

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Study Officials

• Drorith Hochner-Celnikier, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: January 9, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 11, 2013

Record last verified: 2012-12

Locations

IL (1)