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

NCT03331081 | Unknown

• 1 other identifier: 2
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder Syndrome

Keywords

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• BMI

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

• Urinary symptoms

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

• Pregnancies and deliveries

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

• Pad test

  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

  At the initial evaluation of the patient before starting the 3 months of treatment and the end of 3 months of supervised treatment

Study Arms (3)

Group Bladder Training

EXPERIMENTAL

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

Group TMAP

ACTIVE COMPARATOR

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

Group Bladder Training + TMAP

ACTIVE COMPARATOR

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

Interventions

Bladder Training 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 Bladder Training

TMAP 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 TMAP

Bladder Training + TMAP OTHER

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

Group Bladder Training + TMAP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Related Publications (1)

• 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.

  PMID: 37811598 DERIVED

MeSH Terms

Interventions

4,4',5'-trimethylazapsoralen

Study Officials

• Letícia Ferreira

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Letícia Ferreira

CONTACT

11994001829; leticia_azfe@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 6, 2017
• Study Start: November 25, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 20, 2018
• Last Updated: November 6, 2017

Record last verified: 2017-10