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NCT Number: NCT06197295

Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity

To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.

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Key information

Conditions

Urinary Bladder, Overactive Effect of Drug Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

Women with detrusor overactivity who were refractory to anti-muscarinics were enrolled for prospective study. Patients were divided into two groups: one receive combined pharmacotherapy with solifenacin and mirabegron, and the other received solifenacin and vaginal estrogen cream. 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 episodes of daily micturition, urgency, urinary incontinence and nocturia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 anti-muscarinics were enrolled for prospective study.

Exclusion criteria

  • 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.
  • Women who were on hormone replacement therapy within 3 months were also excluded from the study

Treatment and study plan

Solifenacin with vaginal estrogen cream

Drug

Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg

Other names: Premarin

Combination pharmacotherapy

Drug

Solifenacin 5mg and Mirabegron 25mg

Other names: Vesicare and Betmiga

Primary outcomes

  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 outcomes

  1. Episodes of daily micturition

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

    Patients report daily lower urinary tract symptoms episodes

  2. Episodes of daily urgency

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

    Patients report daily lower urinary tract symptoms episodes

  3. Episodes of daily incontinence

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

    Patients report daily lower urinary tract symptoms episodes

  4. Episodes of daily nocturia

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

    Patients report daily lower urinary tract symptoms episodes

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Hsuan Lau, MD

CONTACT

[email protected]

+886-2-25433535

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2024
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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