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

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Bladder Training

TMAP

Bladder Training + TMAP

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring Overactive Bladder Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group Bladder Training

Group TMAP

Group Bladder Training + TMAP

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

BMI

Weight and height will be combined to report BMI in kg / m2

Urinary symptoms

Duration of urinary symptoms

Pregnancies and deliveries

Number of pregnancies and vaginal deliveries

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03331081

First Posted

October 25, 2017

Last Updated

October 31, 2017

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03331081

Brief Title

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

Official Title

Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome - a Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 25, 2017 (Anticipated)

Primary Completion Date

June 30, 2018 (Anticipated)

Study Completion Date

December 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder Syndrome

Keywords

Overactive Bladder Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group Bladder Training

Arm Type

Experimental

Arm Description

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.

Arm Title

Group TMAP

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group Bladder Training + TMAP

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Bladder Training

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

TMAP

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Bladder Training + TMAP

Intervention Description

Will perform the exercises of the bladder training group and the TMAP in an associated way.

Primary Outcome Measure Information:

Title

Evaluation of subjective cure

Description

We consider it "satisfied" when the patient does not want another treatment, and "dissatisfied" when the patient wants another treatment option.

Time Frame

At the end of 3 months of supervised treatment

Secondary Outcome Measure Information:

Title

BMI

Description

Weight and height will be combined to report BMI in kg / m2

Time Frame

At the initial evaluation of the patient before starting the 3 months of treatment

Title

Urinary symptoms

Description

Duration of urinary symptoms

Time Frame

At the initial evaluation of the patient before starting the 3 months of treatment

Title

Pregnancies and deliveries

Description

Number of pregnancies and vaginal deliveries

Time Frame

At the initial evaluation of the patient before starting the 3 months of treatment

Title

Pad test

Description

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.

Time Frame