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

NCT ID: NCT03331081

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-25

Study Completion Date

2018-12-20

Brief Summary

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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

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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.

Conditions

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Overactive Bladder Syndrome

Keywords

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Bladder Training

Intervention Type OTHER

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).

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.

Group Type ACTIVE_COMPARATOR

TMAP

Intervention Type OTHER

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).

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.

Group Type ACTIVE_COMPARATOR

Bladder Training + TMAP

Intervention Type OTHER

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

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Bladder Training + TMAP

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Letícia de Azevedo Ferreira

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Letícia Ferreira

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Central Contacts

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Letícia Ferreira

Role: CONTACT

Phone: 11994001829

Email: [email protected]

References

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Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

Reference Type DERIVED
PMID: 37811598 (View on PubMed)

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id