Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women

Study Overview
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Brief Summary
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This study is a multi-site, randomized, opened and parallel-controlled clinical study. The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.

Official Title
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Multi-site, Randomized, Opened and Controlled Comparison Study on the Effectiveness and Safety of Solifenacin Succinate Tablets and Solifenacin Succinate Tablets + Estrogen for Overactive Bladder in the Post-menopausal Women

Conditions
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Overactive Bladder, Postmenopausal Disorder, Urination Disorders

Intervention / Treatment
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* Drug: Solifenacin Succinate Tablets
* Drug: Estrogen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menopausal women aged ≤75. Signing of ICF. Willing to and able to correctly complete the urination diary. Complications of OAB for ≥12 weeks (including: urgent micturition, frequent urination (≥8 times in the daytime, and ≥2 times at the night) and/or urgent urinary incontinence). No dosing of other drugs of same kind within 14d. -≥8 urination times (24h) in the 1d urination diary. Exclusion Criteria: Clinically-significant dysuria(at the investigators' viewpoints). Serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators. At the ongoing intubatton or the intermittent self-intubatton. Evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors. Uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints. Non-pharmacotherapy (including electrotherapy) or bladder training within 2 weeks before the study initiation (or during the study). Dosing of diuretics and drugs with the cholinergic or anti-cholinergic adverse reactions Known or suspicious allergy to Solifenacin Succinate, other anti-cholinergic drugs or lactose. Clinically-significant symptoms inapplicable for clinical study at the investigators' viewpoints. Participation in other clinical studies within 30d before the random grouping. No completion of urination diary according to relevant instructions. Potentially clinically significant abnormalities (PCSA) inapplicable for clinical study at the investigators' viewpoints.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solifenacin Succinate Tablets and Estrogen capsules<br>Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks | Drug: Solifenacin Succinate Tablets<br> <br> Drug: Estrogen<br> <br> |
| Active Comparator: Solifenacin Succinate Tablets<br>Solifenacin Succinate Tablets (5mg/d) for 12 weeks | Drug: Solifenacin Succinate Tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the mean urination times (24h) at the end of treatment and the baseline value |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the mean urgent micturition times (24h) and the baseline value |  | on week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Solifenacin Succinate Tablets, Estrogen