Clinical trial NCT06209333: Effect of BT and PFET on Urinary Symptoms and Quality of Life in Patients With OABS
Official title: Effect of Bladder Training and Pelvic Floor Exercise Training on Urinary Symptoms and Quality of Life in Patients With Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder Syndrome (OABS)
Keywords: pelvic floor exercise
bladder training
standard patient education
botulinum toxin-A
BTx-A
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
timeFrame: 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
measure: International Incontinence Consultation Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
timeFrame: 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
Secondary outcomes:
measure: International Incontinence Consultation Bladder Diary (ICIQ-Bladder Diary):
timeFrame: change in the severity of urinary incontinence from the beginning to the end of 12 weeks
measure: 1-Hour Ped Test
timeFrame: change in the severity of urinary incontinence from the beginning to the end of 12 weeks
measure: International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS):
timeFrame: Change in quality of life from baseline at 12 weeks
measure: Global Perception of Improvement Scale
timeFrame: Change from baseline patient global change at 12 weeks
measure: Compliance with Standard Patient Education
timeFrame: compliance with Standard Patient Education at the end of 12 weeks
measure: Compliance with Bladder Training
timeFrame: Compliance with Bladder Training at the end of 12 weeks
measure: Compliance with Pelvic Floor Exercise Training
timeFrame: Compliance with Pelvic Floor Exercise Training at the end of 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Aslı Aslan
Study officials:
References:
citation: The Overactive Bladder: From Basic Science to Clinical Management Consensus Conference. Proceedings. London, England, June 29, 1997. Urology. 1997 Dec;50(6A Suppl):1-114. No abstract available.
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citation: Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
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citation: Shen L, Hou L, Li B, Jin X, Han F, Wang Y. Translation of the ICIQ-bladder diary and its validation among Chinese females with lower urinary tract symptoms. Int Urogynecol J. 2020 Dec;31(12):2535-2542. doi: 10.1007/s00192-020-04339-9. Epub 2020 May 28.
citation: Castellani D, Saldutto P, Galica V, Pace G, Biferi D, Paradiso Galatioto G, Vicentini C. Low-Dose Intravaginal Estriol and Pelvic Floor Rehabilitation in Post-Menopausal Stress Urinary Incontinence. Urol Int. 2015;95(4):417-21. doi: 10.1159/000381989. Epub 2015 May 30.
citation: Ptak M, Ciecwiez S, Brodowska A, Starczewski A, Nawrocka-Rutkowska J, Diaz-Mohedo E, Rotter I. The Effect of Pelvic Floor Muscles Exercise on Quality of Life in Women with Stress Urinary Incontinence and Its Relationship with Vaginal Deliveries: A Randomized Trial. Biomed Res Int. 2019 Jan 6;2019:5321864. doi: 10.1155/2019/5321864. eCollection 2019.