Urinary Bladder, Overactive Clinical Trial
Official title:
Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with either anti-muscarinics or ß3-adrenoceptor agonists were enrolled for prospective study Exclusion Criteria: - Postvoid urine retention before treatment |
Country | Name | City | State |
---|---|---|---|
Taiwan | Mackay Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Mackay Memorial Hospital |
Taiwan,
Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8. — View Citation
Mueller ER, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Stoelzel M, Yoon SJ, Al-Shukri S, Rechberger T, Gratzke C. Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study. Neurourol Urodyn. 2019 Feb;38(2):779-792. doi: 10.1002/nau.23919. Epub 2019 Jan 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short form of Urinary Distress Inventory (UDI-6) | UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence. | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment | |
Primary | Short form of Incontinence Impact Questionnaire (IIQ-7) | The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships & emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence. | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment | |
Primary | Overactive Bladder Symptom Score (OABSS) | The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms. | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment | |
Secondary | Maximum cystometric capacity | One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity | Assess during 3 months - 1year after treatment | |
Secondary | Maximum detrusor pressure at first involuntary detrusor contraction | One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity | Assess during 3 months - 1year after treatment | |
Secondary | Volume at first involuntary detrusor contraction | One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity | Assess during 3 months - 1year after treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06201013 -
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
|
N/A | |
Recruiting |
NCT05880862 -
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
|
Early Phase 1 | |
Recruiting |
NCT04807920 -
BOTOX® at the Time of Prolapse Surgery for OAB
|
Phase 4 | |
Terminated |
NCT02385500 -
Fesoterodine on Urgency Episodes in Parkinson's Disease Population
|
Phase 4 | |
Not yet recruiting |
NCT02477241 -
Brain Areas Involved in Bladder Filling and Contraction
|
N/A | |
Completed |
NCT01698138 -
Prevention of Bladder Dysfunction in Acute Spinal Cord Injury
|
Phase 4 | |
Completed |
NCT00527033 -
A Study of YM178 in Patients With Symptomatic Overactive Bladder
|
Phase 2 | |
Completed |
NCT00613327 -
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
|
Phase 4 | |
Completed |
NCT00368706 -
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
|
Phase 3 | |
Recruiting |
NCT04305743 -
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
|
Phase 4 | |
Active, not recruiting |
NCT03681678 -
Laser Therapy for Treatment of Urogenital Symptoms in Women
|
||
Completed |
NCT01655069 -
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
|
Phase 3 | |
Completed |
NCT01558856 -
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
|
N/A | |
Completed |
NCT01521767 -
Pharmacokinetics and Relative Bioavailability Study
|
Phase 1 | |
Completed |
NCT01157377 -
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
|
Phase 2 | |
Completed |
NCT01381120 -
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
|
Phase 4 | |
Completed |
NCT01194999 -
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
|
Phase 4 | |
Completed |
NCT01262391 -
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
|
Phase 1 | |
Completed |
NCT04528784 -
Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis
|
N/A | |
Completed |
NCT02849418 -
Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity
|
Phase 3 |