The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females

Phase 4

• Conditions: Urinary Tract Infection
• Interventions: Drug: Levofloxacin; Drug: Solifenacin succinate; Drug: Placebo (for Solifenacin succinate)

• Registration Number: NCT02094703
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

Brief Summary

The efficacy of Solifenacin Succinate 5 mg as adjuvant therapy and levofloxacin (500 mg) for short-term treatment to reduce symptoms in patients with symptomatic non complicated urinary tract infection in females.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Status Verified: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Study First Posted: 2014-03-24
• Last Update Posted: 2014-03-24
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

• females (18-65 years old)
• dysuria in symptomatic non complicated urinary tract infection

Exclusion Criteria

• Pediatric Patients (< 18 years old)
• geriatric Patients (> 65 years old)
• pregnant Patients
• Patients with complicated urinary tract infection
• sexually transmitted infections
• Patients with pathological abnormalities in the urinary bladder, including stone/mass
• Catheter-mounted
• Neurological diseases/disorders
• patients with allergy/hypersensitivity with Levofloxacin/Solifenacin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levofloxacin and placebo	Levofloxacin	Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days
levofloxacin and solifenacin succinate	Levofloxacin	Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days
levofloxacin and solifenacin succinate	Solifenacin succinate	Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days
levofloxacin and placebo	Placebo (for Solifenacin succinate)	Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days

Primary Outcome Measures

Name	Time	Method
Number of participants with storage symptoms	up to three days

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, Indonesia