Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder

NCT06479720 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 22MMHIS039e-3
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder

Conditions

Effect of Drug; Urinary Bladder, Overactive

Keywords

Detrusor overactivity; Combined pharmacotherapy; Estrogens; 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 (4)

• Episodes of daily micturition

  Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

• Episodes of daily urgency

  Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

• Episodes of daily incontinence

  Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

• Episodes of daily nocturia

  Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment

Study Arms (3)

Solifenacin and mirabegron

ACTIVE COMPARATOR

Solifenacin 5mg and Mirabegron 25mg

Drug: Combined pharmacotherapy with Solifenacin and Mirabegron

Solifenacin with vaginal estrogen cream

EXPERIMENTAL

Solifenacin 5mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.

Drug: Solifenacin with vaginal estrogen cream

Mirabegron with vaginal estrogen cream

EXPERIMENTAL

Mirabegron 25mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week.

Drug: Mirabegron with vaginal estrogen cream

Interventions

Combined pharmacotherapy with Solifenacin and Mirabegron DRUG

Solifenacin (5mg) is anticholinergic and Mirabegron (25mg) is a beta-3 adrenergic agonist.

Also known as: Vesicare and Betmiga

Solifenacin and mirabegron

Solifenacin with vaginal estrogen cream DRUG

Solifenacin (5mg) is anticholinergic. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).

Also known as: Vesicare and Premarin

Solifenacin with vaginal estrogen cream

Mirabegron with vaginal estrogen cream DRUG

Mirabegron (25mg) is a beta-3 adrenergic agonist. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).

Also known as: Betmiga and Premarin

Mirabegron with vaginal estrogen cream

Eligibility Criteria

• Age: 40 Years - 90 Years
• Gender Eligibility Details: The study focus on female overactive bladder.
• 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 anti-muscarinics were enrolled for prospective study.

You may not qualify if:

• Postvoid urine retention before treatment
• Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension
• Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding.

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

• Cardozo L, Lose G, McClish D, Versi E. A systematic review of the effects of estrogens for symptoms suggestive of overactive bladder. Acta Obstet Gynecol Scand. 2004 Oct;83(10):892-7. doi: 10.1111/j.0001-6349.2004.00581.x.

  PMID: 15453881 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate; mirabegron; Estrogens, Conjugated (USP)

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)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

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: NON 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: June 23, 2024
• First Posted: June 28, 2024
• Study Start: June 16, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 9, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)