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Clinical Trials/NCT06209333
NCT06209333
Recruiting
N/A

Effect of Bladder Training and Pelvic Floor Exercise Training on Urinary Symptoms and Quality of Life in Patients With Overactive Bladder Syndrome

Hacettepe University1 site in 1 country50 target enrollmentOctober 15, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overactive Bladder Syndrome (OABS)
Sponsor
Hacettepe University
Enrollment
50
Locations
1
Primary Endpoint
International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 15, 2023
End Date
October 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ceren Gursen

Associate professor

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • over the age of 18 (those with a Mini Mental Test score of 24 and above for individuals over the age of 65),
  • Who has Non-Neurogenic Overactive Bladder Syndrome,
  • Patients who received Routine Botulinum Toxin-A administration because they did not respond to conservative treatment,
  • Patients who volunteer to participate in the study will be included.

Exclusion Criteria

  • Patients with Neurogenic Overactive Bladder Syndrome,
  • Pregnant Women,
  • Lack of cooperation in evaluation and/or treatment and lack of literacy status,
  • Patients with urogynocological/anatomical abnormalities,
  • Patients receiving pelvic radiation therapy,
  • Patients with psychiatric or neurogenic disorders and
  • Patients who have not given consent to the study and do not have an informed consent form (BGOF).

Outcomes

Primary Outcomes

International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)

Time Frame: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life

Storage symptoms are scored as 0-16 points, urination symptoms are scored as 0-12, incontinence symptoms are scored as 0-20 points. The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 48. A higher score means a worse outcome.

International Incontinence Consultation Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)

Time Frame: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life

This scale aims to evaluate male lower urinary tract symptoms in the last 4 weeks and the effects of symptoms on quality of life with 13 questions. The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 52. A higher score means a worse outcome.

Secondary Outcomes

  • Global Perception of Improvement Scale(Change from baseline patient global change at 12 weeks)
  • Compliance with Bladder Training(Compliance with Bladder Training at the end of 12 weeks)
  • International Incontinence Consultation Bladder Diary (ICIQ-Bladder Diary):(change in the severity of urinary incontinence from the beginning to the end of 12 weeks)
  • 1-Hour Ped Test(change in the severity of urinary incontinence from the beginning to the end of 12 weeks)
  • International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS):(Change in quality of life from baseline at 12 weeks)
  • Compliance with Standard Patient Education(compliance with Standard Patient Education at the end of 12 weeks)
  • Compliance with Pelvic Floor Exercise Training(Compliance with Pelvic Floor Exercise Training at the end of 12 weeks)

Study Sites (1)

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