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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833663

Acronym

OAB

Enrollment

200

Registered

2013-04-17

Start date

2011-10-31

Completion date

2013-10-31

Last updated

2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder, Postmenopausal Disorder, Urination Disorders

Keywords

Overactive Bladder, Solifenacin Succinate Tablets, Estrogen

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.

Interventions

DRUGSolifenacin Succinate Tablets

DRUGEstrogen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026