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

Urinary Bladder, Overactive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197295
• Other study ID #: 22MMHIS039e-2
• Status: Recruiting
• Phase: Phase 4
• Start date: June 16, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Mackay Memorial Hospital
• Contact: Hui-Hsuan Lau, MD
• Phone: +886-2-25433535
• Email: huihsuan1220[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Effect of Drug
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin with vaginal estrogen cream
Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg
• Combination pharmacotherapy
Solifenacin 5mg and Mirabegron 25mg

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Episodes of daily micturition	Patients report daily lower urinary tract symptoms episodes	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Secondary	Episodes of daily urgency	Patients report daily lower urinary tract symptoms episodes	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Secondary	Episodes of daily incontinence	Patients report daily lower urinary tract symptoms episodes	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Secondary	Episodes of daily nocturia	Patients report daily lower urinary tract symptoms episodes	Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment