Clinical trial NCT05968885: Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Official title: Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Urodynamics
Effect of Drug
Keywords: Detrusor overactivity
Urodynamic study
Combined pharmacotherapy
Botulinum Toxins
Effectiveness
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 β3-adrenoceptor agonists were enrolled for prospective study

Exclusion Criteria:

* Postvoid urine retention before treatment

Primary outcomes:
measure: Short form of Urinary Distress Inventory (UDI-6)
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
measure: Short form of Incontinence Impact Questionnaire (IIQ-7)
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
measure: Overactive Bladder Symptom Score (OABSS)
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Secondary outcomes:
measure: Maximum cystometric capacity
timeFrame: Assess during 3 months - 1year after treatment
measure: Maximum detrusor pressure at first involuntary detrusor contraction
timeFrame: Assess during 3 months - 1year after treatment
measure: Volume at first involuntary detrusor contraction
timeFrame: Assess during 3 months - 1year after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Hui-Hsuan Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.