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

Overactive Bladder Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03331081
• Other study ID #: 2
• Status: Not yet recruiting
• Phase: N/A
• First received: October 25, 2017
• Last updated: October 31, 2017
• Start date: November 25, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: October 2017
• Source: Federal University of São Paulo
• Contact: Letícia Ferreira
• Phone: 11994001829
• Email: leticia_azfe[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 20, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

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).
• 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).
• Bladder Training + TMAP
Will perform the exercises of the bladder training group and the TMAP in an associated way.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Urinary symptoms	Duration of urinary symptoms	At the initial evaluation of the patient before starting the 3 months of treatment
Secondary	Pregnancies and deliveries	Number of pregnancies and vaginal deliveries	At the initial evaluation of the patient before starting the 3 months of treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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