Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises
1 other identifier
interventional
72
0 countries
N/A
Brief Summary
To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedAugust 3, 2016
August 1, 2016
Same day
July 28, 2016
August 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pad test
To quantify the severity of SUI and as the tool to estimate objective cure rate
Baseline, after 3 months of supervised treatment and at 9-month follow-up
Secondary Outcomes (7)
Change in 7-Day Voiding Diary
Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Oxford Grading Scale)
Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Peritron manometer)
Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
Baseline, after 3 months of supervised treatment and at 9-month follow-up
Subjective cure of SUI ("satisfied" or "dissatisfied")
After 3 months of supervised treatment and at 9-month follow-up
- +2 more secondary outcomes
Study Arms (2)
BF group
EXPERIMENTAL24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises.
PFMT group
ACTIVE COMPARATOR24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises.
Interventions
24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
Eligibility Criteria
You may qualify if:
- SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test
You may not qualify if:
- younger than 18 years old
- chronic degenerative diseases
- pelvic organ prolapse greater than stage I by POP-Q
- neurologic or psychiatric diseases
- previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatima F Fitz, M.Sc
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical Therapist
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 2, 2016
Study Start
March 1, 2011
Primary Completion
March 1, 2011
Study Completion
September 1, 2014
Last Updated
August 3, 2016
Record last verified: 2016-08