Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05968885
• Other study ID #: 22MMHIS039e
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Effect of Drug
• Urinary Bladder, Overactive
• Urodynamics

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