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

Mackay Memorial Hospital

Status and phase: Enrolling; Phase 4

Conditions: Urodynamics; Urinary Bladder, Overactive; Effect of Drug

Treatments: Procedure: Intradetrusor Botox® (onabotulinumtoxinA) injection; Drug: Combine Mirabegron and Solifenacin.

Study type: Interventional

Funder types: Other

Identifiers

NCT05968885

22MMHIS039e

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Intradetrusor onabotulinumtoxinA injection

Active Comparator group

Description:

The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.

Treatment:

Procedure: Intradetrusor Botox® (onabotulinumtoxinA) injection

Combination pharmacotherapy

Experimental group

Description:

Combine Mirabegron and Solifenacin.

Treatment:

Drug: Combine Mirabegron and Solifenacin.