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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Disorder; Urination Disorders; Overactive Bladder

Treatments: Drug: Estrogen; Drug: Solifenacin Succinate Tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01833663

XH-WXK-001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Solifenacin Succinate Tablets and Estrogen capsules

Experimental group

Description:

Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks

Treatment:

Drug: Solifenacin Succinate Tablets

Drug: Estrogen

Solifenacin Succinate Tablets

Active Comparator group

Description:

Solifenacin Succinate Tablets (5mg/d) for 12 weeks

Treatment:

Drug: Solifenacin Succinate Tablets