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

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ClinicalTrials.gov Identifier: NCT05968885
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
Hui-Hsuan Lau, Mackay Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Urodynamics Effect of Drug Procedure: Intradetrusor Botox® (onabotulinumtoxinA) injection Drug: Combine Mirabegron and Solifenacin. Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intradetrusor 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.
 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.
Experimental: Combination pharmacotherapy
Combine Mirabegron and Solifenacin.
 Drug: Combine Mirabegron and Solifenacin.
Combination pharmacotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Short form of Urinary Distress Inventory (UDI-6) [ Time Frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment ]
    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.

  2. Short form of Incontinence Impact Questionnaire (IIQ-7) [ Time Frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment ]
    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.

  3. Overactive Bladder Symptom Score (OABSS) [ Time Frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment ]
    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.


Secondary Outcome Measures :
  1. Maximum cystometric capacity [ Time Frame: Assess during 3 months - 1year after treatment ]
    One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity

  2. Maximum detrusor pressure at first involuntary detrusor contraction [ Time Frame: Assess during 3 months - 1year after treatment ]
    One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity

  3. Volume at first involuntary detrusor contraction [ Time Frame: Assess during 3 months - 1year after treatment ]
    One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study focus on female detrusor overactivity.
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05968885


Contacts
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Contact: Hui-Hsuan Lau, MD +886-2-25433535 huihsuan1220@gmail.com

Locations
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Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Jiun Chyi Hwang, MD    +886-2-2543-3535    jiun1989@gmail.com   
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
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Principal Investigator: Hui-Hsuan Lau, MD Mackay Memorial Hospital
More Information
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Publications:

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Responsible Party: Hui-Hsuan Lau, Head of urogynecology, Associate Professor, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT05968885    
Other Study ID Numbers: 22MMHIS039e
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: August 1, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hui-Hsuan Lau, Mackay Memorial Hospital:
Detrusor overactivity
Urodynamic study
Combined pharmacotherapy
Botulinum Toxins
Effectiveness
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Solifenacin Succinate
Mirabegron
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Muscarinic Antagonists
Cholinergic Antagonists
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents