Effect of BT and PFET on Urinary Symptoms and Quality of Life in Patients With OABS

Summary

The aim of this study was to examine the effects of bladder training and pelvic floor exercise training programs given in addition to Botulinum Toxin-A (BTx-A) application on urinary symptoms and quality of life in patients with Overactive Bladder Syndrome (AAMS) who do not respond to conservative treatments.

Individuals who meet the criteria for inclusion in the study and agree to participate in the study will be divided into 2 separate research branches.The patients to be included in the study will be divided into two groups as "Group 1=Botox + physiotherapy " or "Group 2=Botox group ". In addition to the BTx-A application, bladder training and pelvic floor exercise training will be applied to patients in the first group, while standard patient training will be provided to patients in the second group.

Severity of urinary symptoms, quality of life and subjective perception of improvement Before BTx-A application, 2 weeks and 12 weeks after BTX-A application, International Incontinence Consultation Questionnaire - Women's Lower Urinary Tract Symptoms (ICIQ-FLUTS), 1-hour ped test, International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS) and Global Perception of Improvement will be evaluated.

Conditions

• Overactive Bladder Syndrome (OABS)

Interventions

OTHER

Standard Patient Education

Standard Patient Education will take approximately 20 minutes. Within the scope of standard patient education, some recommendations will be made to the patient to lose weight, drink sufficient water, avoid consuming caffeinated foods and beverages, acidic/carbonated or alcoholic beverages, spicy/acidic foods, and quit smoking. Patients will be evaluated on the day they receive standard patient training (before receiving this training) and 10 weeks after the training.

OTHER

bladder training

Interval urination in bladder training in bladder training will be determined according to the bladder diaries filled in by the patients. If the patient is able to do it, bladder education will be improved by increasing the interval urination in bladder training. A total of 5 sessions of bladder training will be applied to patients, the first session of which will be face-to-face. Within the scope of Bladder Training, the patient will be given information about bladder, pelvic floor, incontinence and relaxation techniques. The patient will be asked to fill out a 3-day bladder diary before starting bladder training, and an appropriate progressive timed voiding program will be drawn according to the bladder diaries, and the patient will be given a training brochure to implement this program.

OTHER

pelvic floor exercise

This training will take between 45 and 60 minutes.Within the scope of exercise training, patients will be taught 3 types of contractions: maximal (fast), slow and submaximal contractions. The patient will be asked to continue the maximum and submaximal contraction for 1-2 seconds, and to continue the Deceleration contraction for 3-10 seconds. These contractions will be performed in different positions such as supine, lying on the side, sitting, crawling, squatting and standing, specifically for the pelvic floor November muscle strength of the patient. These exercises will be performed every day and each type of contraction (maximal, slow and submaximal contraction) will be performed 8-12 repetitions, 3 sets per day. Progress will be achieved with follow-ups.

Sponsors & Collaborators

• Hacettepe University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-15

Primary Completion

2024-10-15

Completion

2024-10-15

Countries

• Turkey (Türkiye)

Study Locations