Clinical trial NCT06197295: Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity
Official title: Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Effect of Drug
Keywords: Detrusor overactivity
Combined pharmacotherapy
Estrogens
Effectiveness
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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 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

Primary outcomes:
measure: Short form of Urinary Distress Inventory (UDI-6)
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
measure: Short form of Incontinence Impact Questionnaire (IIQ-7)
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
measure: Overactive Bladder Symptom Score (OABSS)
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Secondary outcomes:
measure: Episodes of daily micturition
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
measure: Episodes of daily urgency
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
measure: Episodes of daily incontinence
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
measure: Episodes of daily nocturia
timeFrame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Hui-Hsuan Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.