Effect of BT and PFET on Urinary Symptoms and Quality of Life in Patients With OABS
- Conditions
- Overactive Bladder Syndrome (OABS)
- Interventions
- Other: Standard Patient EducationOther: bladder trainingOther: pelvic floor exercise
- Registration Number
- NCT06209333
- Lead Sponsor
- Hacettepe University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard patient education Standard Patient Education - pelvic physiotherapy pelvic floor exercise - pelvic physiotherapy bladder training -
- Primary Outcome Measures
Name Time Method International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) 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) 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 Outcome Measures
Name Time Method Global Perception of Improvement Scale Change from baseline patient global change at 12 weeks The Global Perception of Improvement Scale, the perception of changes in patients' complaints related to overactive bladder symptoms after the study compared to the beginning of the study, will be evaluated by the Global Perception of Improvement Scale, which is a 7-item scale (1-I am much better, 7-much worse). A higher score means a worse outcome.
Compliance with Bladder Training Compliance with Bladder Training at the end of 12 weeks It will be evaluated with a Visual Analog Scale. 12. at the end of the week, they will be asked to mark on the VAS how much they have implemented this training throughout the study.
International Incontinence Consultation Bladder Diary (ICIQ-Bladder Diary): change in the severity of urinary incontinence from the beginning to the end of 12 weeks ICIQ-Bladder Diary is a volume-frequency chart that allows patients to record the frequency of urination, the volume of mixing and fluid intake (quantity, duration and type), bladder sensation and pad use at each time.
1-Hour Ped Test change in the severity of urinary incontinence from the beginning to the end of 12 weeks Just before this test, the patient is asked to empty his bladder and put the pad, the weight of which is known in advance, in his clothes.
Then, the patient is asked to do 500 mL of oral hydration while sitting for 15 minutes. the time is completed with other activities.
60. the pad is taken from the patient per minute. During this time, the weight difference on the pad is measured and the test is interpreted according to the difference.International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS): Change in quality of life from baseline at 12 weeks Quality of life will be evaluated by the International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS). This scale consists of 20 questions that evaluate different sub-areas of quality of life (work life, daily life, travel and sexuality).The highest possible score is 76. A higher score means a worse outcome.
Compliance with Standard Patient Education compliance with Standard Patient Education at the end of 12 weeks It will be evaluated with a Visual Analog Scale. The Visual Analog Scale (VAS) is a horizontal line of 0-10 cm that expresses that it does not fit education at all at one end and that it adapts to patient education to the maximum extent at the other end. A higher score means better fit.
Compliance with Pelvic Floor Exercise Training Compliance with Pelvic Floor Exercise Training at the end of 12 weeks It will be evaluated with exercise diaries.
Trial Locations
- Locations (1)
Aslı Aslan
🇹🇷Ankara, Turkey