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Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331081
Recruitment Status : Unknown
Verified October 2017 by Letícia de Azevedo Ferreira, Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Letícia de Azevedo Ferreira, Federal University of São Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Other: Bladder Training Other: TMAP Other: Bladder Training + TMAP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome - a Randomized Controlled Clinical Trial
Estimated Study Start Date : November 25, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group Bladder Training
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.
Other: Bladder Training
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).

Active Comparator: Group TMAP
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.
Other: TMAP
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).

Active Comparator: Group Bladder Training + TMAP
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.
Other: Bladder Training + TMAP
Will perform the exercises of the bladder training group and the TMAP in an associated way.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. BMI [ Time Frame: At the initial evaluation of the patient before starting the 3 months of treatment ]
    Weight and height will be combined to report BMI in kg / m2

  2. Urinary symptoms [ Time Frame: At the initial evaluation of the patient before starting the 3 months of treatment ]
    Duration of urinary symptoms

  3. Pregnancies and deliveries [ Time Frame: At the initial evaluation of the patient before starting the 3 months of treatment ]
    Number of pregnancies and vaginal deliveries

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331081


Contacts
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Contact: Letícia Ferreira 11994001829 leticia_azfe@hotmail.com

Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Letícia Ferreira Federal University of São Paulo

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Responsible Party: Letícia de Azevedo Ferreira, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03331081    
Other Study ID Numbers: 2
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Letícia de Azevedo Ferreira, Federal University of São Paulo:
Overactive Bladder Syndrome
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Syndrome
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms