Overactive Bladder SyndromeNCT03331081
Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome
A study testing Bladder Training, TMAP and Bladder Training + TMAP in people with Overactive Bladder Syndrome, run by Federal University of São Paulo.
Trial summary
The question is whether vesical training and TMAP can be used in isolation without treatment of overactive bladder syndrome? ALSO will be evaluated in urinary symptoms, a function of the MAP, a quality of life and a satisfaction of the women with the treatment offered. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Bladder Training, TMAP and Bladder Training + TMAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2017to 20 Dec 2018
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with IUU and / or IUM with a predominance of urinary urgency, capable of contracting MAPs adequately, and who agree to participate in the study, signing the Informed Consent Form.
Who cannot join
- Women with a diagnosis of glaucoma, myasthenia gravis, urinary tract obstruction, neurological and chronic-degenerative diseases, decompensated diabetic patients and patients with complete denervation of the pelvic floor, pregnancy, abnormal genital bleeding, impairment of cognition, inability to fill in the diary voiding, genital dystopias beyond the vaginal introitus and urethral sphincter defect. Patients may not be in use or have used anticholinergics, tricyclic antidepressants or local hormone therapy within the six months prior to the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome - a Randomized Controlled Clinical Trial
The question is whether vesical training and TMAP can be used in isolation without treatment of overactive bladder syndrome? ALSO will be evaluated in urinary symptoms, a function of the MAP, a quality of life and a satisfaction of the women with the treatment offered.
Read the detailed description
Bladder training includes as resources the educational program, lifestyle modifications, as a strategy to suppress urgency and as programmed urges to improve the control of urgency and incontinence; increase bladder capacity, and thus prolong the intervals between such as urination; giving the patient a confidence in the bladder control. Already, a justification for the use of TMAP is a contraction of the pelvic floor muscles (MAP) inhibits detrusor contraction, improving the symptoms of detrusor overactivity.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Bladder Training, TMAP, Bladder Training + TMAP
- Keywords
- Overactive Bladder Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder TrainingOther
The patient will participate in a class in which the physiotherapist will provide the following information: on the anatomy and function of the MAP, using figures; on bladder function; guidelines on the positioning and voiding habits and the definition and main risk factors responsible for urinary incontinence. The bladder training will consist of a program of time micturition to increase bladder capacity and the interval between urinations. Urge suppression strategies will be targeted, and include distraction, relaxation, breathing, and MAP contraction (quick flicks).
TMAPOther
There will be 36 monthly series of home training (totaling at the end of the 3 months of treatment 108 series) performed 3x / week, 3x / day. The training protocol consists of three daily TMAP series. One series consists of 8 maximum voluntary contractions, with maintenance of the contraction of 6 to 10 seconds (type I muscle fibers), with twice the rest time between contractions, followed by three to five rapid contractions (muscle fibers type II ). The protocol will total 24 contractions of MAP per day performed, which will be divided in the morning (8 contractions), late (8 contractions) and night (8 contractions).
Bladder Training + TMAPOther
Will perform the exercises of the bladder training group and the TMAP in an associated way.
| Study group | Role | What they receive |
|---|---|---|
| Group Bladder Training | Experimental | Patients will receive verbal instructions on bladder function (filling and bladder emptying phases), pelvic floor musculature on bladder function; orientation on urinary positioning and habits (urinary frequency); and the definition and major risk factors responsible for urinary incontinence. Receives: Other: Bladder Training |
| Group TMAP | Active comparator | In this group the patients will perform TMAP in isolation. The training protocol aims at the work of strength and muscular hypertrophy, with concentric-isometric muscular action and load of 100% of the maximum voluntary contraction. Receives: Other: TMAP |
| Group Bladder Training + TMAP | Active comparator | In this group, the patients should perform the proposed exercises for the Bladder Training Group and the exercises proposed for the TMAP Group. The training protocol of this group will consist of exercises that have as objectives: to improve the control over the urgency and urge-incontinence; increase bladder capacity, and thus prolong the intervals between urinations; to restore confidence in bladder control; and improve MAP strength and hypertrophy. Receives: Other: Bladder Training + TMAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of subjective cure
We consider it "satisfied" when the patient does not want another treatment, and "dissatisfied" when the patient wants another treatment option.
Measured: At the end of 3 months of supervised treatment
Secondary outcomes (8)
BMI
Weight and height will be combined to report BMI in kg / m2
Measured: At the initial evaluation of the patient before starting the 3 months of treatment
Urinary symptoms
Duration of urinary symptoms
Measured: At the initial evaluation of the patient before starting the 3 months of treatment
Pregnancies and deliveries
Number of pregnancies and vaginal deliveries
Measured: At the initial evaluation of the patient before starting the 3 months of treatment
Pad test
The patient will be instructed to empty the bladder and place a preweighed absorbent. Afterwards, the patient will be asked to ingest 500 ml of sodium free (water) liquid during the first 15 minutes of the examination. After the rest period of 1 hour, the patient will be guided to walk for 30 minutes, in which she must climb and descend five flights of stairs for ten consecutive times. Next, a sequence of exercises will be performed: coughing vigorously for 10 times, squatting 10 times, jumping in place 10 times, and washing hands in running water for 1 minute. Once the activities are over, the absorbent will be weighed again to check for urinary loss.
Measured: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
V8 questionnaire
This scale includes eight issues of urgency, incontinence, nocturia, and voiding frequency. The score for each response varies from 0 (no nuisance) to 5 (extremely uncomfortable), reaching a total of 40 points, being considered positive for SBH when the sum of the questions is equal to or greater than eight.
Measured: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
Voiding diary
Patients should document how many times they go to the restroom during the day and at night, as well as the loss of urine in stressful situations (coughing, sneezing, laughter, squatting, weightlifting, walking, running), changing liner or absorbent and episodes of urgency and urgency-incontinence. The journal shall be held for a consecutive period of 24 hours, for a minimum of three consecutive days.
Measured: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
Quality of life
Incontinence Quality of Life Questionnaire - I-QoL: It is composed of 22 questions organized in three domains. Limitation of human behavior; psychosocial impact; embarrassment and social embarrassment. The values added should vary between 0 and 100 points, and the lower the number obtained the greater the impact of urinary incontinence on quality of life.
Measured: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
MAP function
NEW PERFECT: The examiner's fingers will be positioned approximately four centimeters from the vaginal introitus, and muscle function will be assessed. The examiner's fingers will be positioned approximately four centimeters from the vaginal introitus, and muscle function will be assessed.
Measured: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 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 posted6 Nov 2017
- Study start25 Nov 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion20 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Letícia de Azevedo Ferreira, Federal University of São Paulo
- Investigators
- Letícia Ferreira, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331081
- Sponsor's protocol ID
- 2
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
PubMed 37811598
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome - a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03331081
- Acronym / sponsor ID
- 2
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Overactive Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 25 Nov 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 20 Dec 2018 (estimated)
- First posted
- 6 Nov 2017 (actual)
- 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 question is whether vesical training and TMAP can be used in isolation without treatment of overactive bladder syndrome? ALSO will be evaluated in urinary symptoms, a function of the MAP, a quality of life and a satisfaction of the women with the treatment offered.
Detailed description
Bladder training includes as resources the educational program, lifestyle modifications, as a strategy to suppress urgency and as programmed urges to improve the control of urgency and incontinence; increase bladder capacity, and thus prolong the intervals between such as urination; giving the patient a confidence in the bladder control. Already, a justification for the use of TMAP is a contraction of the pelvic floor muscles (MAP) inhibits detrusor contraction, improving the symptoms of detrusor overactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Bladder Training | Experimental | Other: Bladder TrainingPatients will receive verbal instructions on bladder function (filling and bladder emptying phases), pelvic floor musculature on bladder function; orientation on urinary positioning and habits (urinary frequency); and the definition and major risk factors responsible for urinary incontinence. |
| Group TMAP | Active comparator | Other: TMAPIn this group the patients will perform TMAP in isolation. The training protocol aims at the work of strength and muscular hypertrophy, with concentric-isometric muscular action and load of 100% of the maximum voluntary contraction. |
| Group Bladder Training + TMAP | Active comparator | Other: Bladder Training + TMAPIn this group, the patients should perform the proposed exercises for the Bladder Training Group and the exercises proposed for the TMAP Group. The training protocol of this group will consist of exercises that have as objectives: to improve the control over the urgency and urge-incontinence; increase bladder capacity, and thus prolong the intervals between urinations; to restore confidence in bladder control; and improve MAP strength and hypertrophy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with IUU and / or IUM with a predominance of urinary urgency, capable of contracting MAPs adequately, and who agree to participate in the study, signing the Informed Consent Form.
Key exclusion criteria (1 listed)
- Women with a diagnosis of glaucoma, myasthenia gravis, urinary tract obstruction, neurological and chronic-degenerative diseases, decompensated diabetic patients and patients with complete denervation of the pelvic floor, pregnancy, abnormal genital bleeding, impairment of cognition, inability to fill in the diary voiding, genital dystopias beyond the vaginal introitus and urethral sphincter defect. Patients may not be in use or have used anticholinergics, tricyclic antidepressants or local hormone therapy within the six months prior to the study.
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 |
|---|---|---|
| Bladder TrainingThe patient will participate in a class in which the physiotherapist will provide the following information: on the anatomy and function of the MAP, using figures; on bladder function; guidelines on the positioning and voiding habits and the definition and main risk factors responsible for urinary incontinence. The bladder training will consist of a program of time micturition to increase bladder capacity and the interval between urinations. Urge suppression strategies will be targeted, and include distraction, relaxation, breathing, and MAP contraction (quick flicks). | Other | Group Bladder Training |
| TMAPThere will be 36 monthly series of home training (totaling at the end of the 3 months of treatment 108 series) performed 3x / week, 3x / day. The training protocol consists of three daily TMAP series. One series consists of 8 maximum voluntary contractions, with maintenance of the contraction of 6 to 10 seconds (type I muscle fibers), with twice the rest time between contractions, followed by three to five rapid contractions (muscle fibers type II ). The protocol will total 24 contractions of MAP per day performed, which will be divided in the morning (8 contractions), late (8 contractions) and night (8 contractions). | Other | Group TMAP |
| Bladder Training + TMAPWill perform the exercises of the bladder training group and the TMAP in an associated way. | Other | Group Bladder Training + TMAP |
Primary outcome
Evaluation of subjective cure
Time frame: At the end of 3 months of supervised treatment
We consider it "satisfied" when the patient does not want another treatment, and "dissatisfied" when the patient wants another treatment option.
8 secondary outcomes
BMI
Time frame: At the initial evaluation of the patient before starting the 3 months of treatment
Urinary symptoms
Time frame: At the initial evaluation of the patient before starting the 3 months of treatment
Pregnancies and deliveries
Time frame: At the initial evaluation of the patient before starting the 3 months of treatment
Pad test
Time frame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
V8 questionnaire
Time frame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
Voiding diary
Time frame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
Quality of life
Time frame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
MAP function
Time frame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 37811598Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Letícia Ferreira principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Training, TMAP and Bladder Training + TMAP in people with Overactive Bladder Syndrome, 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 1 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: status not confirmed, as of the sponsor's last update on 6 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Letícia Ferreira (11994001829, leticia_azfe@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of subjective cure (time frame: At the end of 3 months of supervised treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331081, which also lists 1 linked publication.
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 6 Nov 2017.