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

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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Other: Bladder Training; Other: TMAP; Other: Bladder Training + TMAP

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of 3 months of supervised treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Weight and height will be combined to report BMI in kg / m2	At the initial evaluation of the patient before starting the 3 months of treatment
Urinary symptoms	Duration of urinary symptoms	At the initial evaluation of the patient before starting the 3 months of treatment
Pregnancies and deliveries	Number of pregnancies and vaginal deliveries	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.	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.	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.	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.	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.	At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Letícia Ferreira, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2017
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): December 20, 2018

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Overactive Bladder Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Urinary Bladder, Overactive; Syndrome
• Other Study ID Numbers: 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No