Urinary Incontinence, StressNCT02851719
Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises
A study testing PFMT with biofeedback + Home PFMT and PFMT without biofeedback + Home PFMT in people with Urinary Incontinence, Stress, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- PFMT with biofeedback + Home PFMT and PFMT without biofeedback + Home PFMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Sep 2014
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test
Who cannot join
- 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
About this study
Official title: Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: a Randomized Controlled Trial
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.
Read the detailed description
Introduction: The aim of this study was to test the hypothesis that outpatient BF added to home PFMT results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. Secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not BF together with PFMT after 3 months of supervised training, and in a longer term of 9-month follow-up.
Method: 72 incontinent women were randomized to the: BF Group (outpatient BF + home PFMT) or PFMT Group (outpatient PFMT + home PFMT).
Assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home PFMT without supervision).
Primary outcomes: adherence - monthly exercises sets performed (exercise diary) and objective cure of SUI (pad test) after 3 months.
Secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- PFMT with biofeedback + Home PFMT, PFMT without biofeedback + Home PFMT
- Keywords
- Urinary Incontinence, Stress, Pelvic Floor, Exercise, Patient Compliance
- Medical subject headings
- Urinary Incontinence, Stress, Motor Activity, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMT with biofeedback + Home PFMTOther
Also called Biofeedback
24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
PFMT without biofeedback + Home PFMTOther
Also called PFMT alone
24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
| Study group | Role | What they receive |
|---|---|---|
| BF group | Experimental | 24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises. Receives: Other: PFMT with biofeedback + Home PFMT |
| PFMT group | Active comparator | 24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises. Receives: Other: PFMT without biofeedback + Home PFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pad test
To quantify the severity of SUI and as the tool to estimate objective cure rate
Measured: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Secondary outcomes (7)
Change in 7-Day Voiding Diary
To assess the loss efforts
Measured: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Oxford Grading Scale)
To assess the function of the pelvic floor muscle
Measured: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Peritron manometer)
To assess the function of the pelvic floor muscle
Measured: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
To quantify the impact of SUI on quality of life
Measured: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Subjective cure of SUI ("satisfied" or "dissatisfied")
To evaluate the patient satisfaction with treatment
Measured: After 3 months of supervised treatment and at 9-month follow-up
Frequency and adhesion to the home exercises
The weekly frequency (days/week that patients performed at least 1 set of exercises) and the number of sets per day
Measured: After 3 months of supervised treatment and at 9-month follow-up
Frequency of the outpatient sessions
The frequency of the outpatient sessions was monitored
Measured: After 3 months of supervised treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startMar 2011
- Primary completionMar 2011
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Fatima Fitz, Federal University of São Paulo
- Investigators
- Fatima F Fitz, M.Sc, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851719
- Sponsor's protocol ID
- 02
- Status last verified
- Aug 2016
- First submitted
- 28 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The individual participant data (IPD) collected in this study are being analyzed by the researchers to be available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02851719
- Acronym / sponsor ID
- 02
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Urinary Incontinence, Stress, Pelvic Floor, Exercise, Patient Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Aug 2016 (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.
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.
Detailed description
Introduction: The aim of this study was to test the hypothesis that outpatient BF added to home PFMT results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. Secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not BF together with PFMT after 3 months of supervised training, and in a longer term of 9-month follow-up.
Method: 72 incontinent women were randomized to the: BF Group (outpatient BF + home PFMT) or PFMT Group (outpatient PFMT + home PFMT).
Assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home PFMT without supervision).
Primary outcomes: adherence - monthly exercises sets performed (exercise diary) and objective cure of SUI (pad test) after 3 months.
Secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF group | Experimental | Other: PFMT with biofeedback + Home PFMT24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises. |
| PFMT group | Active comparator | Other: PFMT without biofeedback + Home PFMT24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| PFMT with biofeedback + Home PFMTAlso: Biofeedback24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment). | Other | BF group |
| PFMT without biofeedback + Home PFMTAlso: PFMT alone24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment). | Other | PFMT group |
Primary outcome
Change in pad test
Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
To quantify the severity of SUI and as the tool to estimate objective cure rate
7 secondary outcomes
Change in 7-Day Voiding Diary
Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Oxford Grading Scale)
Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Peritron manometer)
Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Subjective cure of SUI ("satisfied" or "dissatisfied")
Time frame: After 3 months of supervised treatment and at 9-month follow-up
Frequency and adhesion to the home exercises
Time frame: After 3 months of supervised treatment and at 9-month follow-up
Frequency of the outpatient sessions
Time frame: After 3 months of supervised treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: Undecided. The individual participant data (IPD) collected in this study are being analyzed by the researchers to be available.
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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.
Fatima F Fitz, M.Sc principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing PFMT with biofeedback + Home PFMT and PFMT without biofeedback + Home PFMT in people with Urinary Incontinence, Stress, run by Federal University of São Paulo.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 3 Aug 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 pad test (time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up). 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 3 Aug 2016.