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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05968885
Other study ID # 22MMHIS039e
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 1, 2021
Est. completion date June 30, 2025

Study information

Verified date July 2023
Source Mackay Memorial Hospital
Contact Hui-Hsuan Lau, MD
Phone +886-2-25433535
Email huihsuan1220@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.


Description:

Patients with detrusor overactivity who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study. Patient were divided in two groups, intradetrusor onabotulinumtoxinA injection and combined pharmacotherapy with Mirabegron and Solifenacin. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in daily urgency episodes, urinary incontinence episodes, maximum cystometric capacity, maximum detrusor pressure (Pdetmax) at first involuntary detrusor contraction and volume at first involuntary detrusor contraction were measured.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intradetrusor Botox® (onabotulinumtoxinA) injection
The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
Drug:
Combine Mirabegron and Solifenacin.
Combination pharmacotherapy

Locations

Country Name City State
Taiwan Mackay Memorial Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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

Outcome

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
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