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

Phase 4

Completed

• Conditions: Overactive Bladder; Postmenopausal Disorder; Urination Disorders
• Interventions: Drug: Solifenacin Succinate Tablets; Drug: Estrogen

• Registration Number: NCT01833663
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-14
• Study First Posted: 2013-04-17
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solifenacin Succinate Tablets and Estrogen capsules	Solifenacin Succinate Tablets	Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks
Solifenacin Succinate Tablets and Estrogen capsules	Estrogen	Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks
Solifenacin Succinate Tablets	Solifenacin Succinate Tablets	Solifenacin Succinate Tablets (5mg/d) for 12 weeks

Primary Outcome Measures

Name	Time	Method
Difference between the mean urination times (24h) at the end of treatment and the baseline value	12 weeks

Secondary Outcome Measures

Name	Time	Method
Difference between the mean urgent micturition times (24h) and the baseline value	on week 12

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China