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

NCT05968885 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 22MMHIS039e
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Bladder, Overactive; Urodynamics; Effect of Drug

Keywords

Detrusor overactivity; Urodynamic study; Combined pharmacotherapy; Botulinum Toxins; Effectiveness

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Maximum cystometric capacity

  Assess during 3 months - 1year after treatment

• Maximum detrusor pressure at first involuntary detrusor contraction

  Assess during 3 months - 1year after treatment

• Volume at first involuntary detrusor contraction

  Assess during 3 months - 1year after treatment

Study Arms (2)

Intradetrusor onabotulinumtoxinA injection

ACTIVE COMPARATOR

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

Combination pharmacotherapy

EXPERIMENTAL

Combine Mirabegron and Solifenacin.

Drug: Combine Mirabegron and Solifenacin.

Interventions

Intradetrusor Botox® (onabotulinumtoxinA) injection PROCEDURE

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

Intradetrusor onabotulinumtoxinA injection

Combine Mirabegron and Solifenacin. DRUG

Combination pharmacotherapy

Combination pharmacotherapy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Gender Eligibility Details: The study focus on female detrusor overactivity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Postvoid urine retention before treatment

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

RECRUITING

Related Publications (3)

• 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.

  PMID: 31039103 BACKGROUND

• 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.

  PMID: 30644570 BACKGROUND

• Hsieh MH, Hwang JC, Su TH, Lau HH. The Efficacy and Safety Between Intradetrusor OnabotulinumtoxinA Injection and Combined Pharmacotherapy in Patients With Refractory Overactive Bladder: A Randomized Controlled Trial. J Urol. 2025 Oct;214(4):344-353. doi: 10.1097/JU.0000000000004660. Epub 2025 Jul 1.

  PMID: 40590342 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A; Injections; Solifenacin Succinate

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hui-Hsuan Lau, MD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Hsuan Lau, MD

CONTACT

+886-2-25433535; huihsuan1220@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of urogynecology, Associate Professor

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: August 1, 2023
• Study Start: October 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)