Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    200
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.
Study Started
Oct 31
2011
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Last Update
Mar 20
2014
Estimate

Drug Solifenacin Succinate Tablets

Drug Estrogen

Solifenacin Succinate Tablets and Estrogen capsules Experimental

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

Solifenacin Succinate Tablets Active Comparator

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

Criteria

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.
No Results Posted