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

Last updated: January 16, 2024
Sponsor: Hacettepe University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Standard Patient Education

bladder training

pelvic floor exercise

Clinical Study ID

NCT06209333
KA-23003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • over the age of 18 (those with a Mini Mental Test score of 24 and above forindividuals over the age of 65),
  • Who has Non-Neurogenic Overactive Bladder Syndrome,
  • Patients who received Routine Botulinum Toxin-A administration because they did notrespond to conservative treatment,
  • Patients who volunteer to participate in the study will be included.

Exclusion

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 consentform (BGOF).

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Standard Patient Education
Phase:
Study Start date:
October 15, 2023
Estimated Completion Date:
October 15, 2024

Connect with a study center

  • Aslı Aslan

    Ankara, 06100
    Turkey

    Active - Recruiting

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