Clinical trial NCT03331081: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: Overactive Bladder Syndrome
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of subjective cure
timeFrame: At the end of 3 months of supervised treatment
Secondary outcomes:
measure: BMI
timeFrame: At the initial evaluation of the patient before starting the 3 months of treatment
measure: Urinary symptoms
timeFrame: At the initial evaluation of the patient before starting the 3 months of treatment
measure: Pregnancies and deliveries
timeFrame: At the initial evaluation of the patient before starting the 3 months of treatment
measure: Pad test
timeFrame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
measure: V8 questionnaire
timeFrame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
measure: Voiding diary
timeFrame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
measure: Quality of life
timeFrame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
measure: MAP function
timeFrame: At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Letícia Ferreira
role: PRINCIPAL_INVESTIGATOR
References: