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

Dr Cipto Mangunkusumo General Hospital

Status and phase: Unknown; Phase 4

Conditions: Urinary Tract Infection

Treatments: Drug: Solifenacin succinate; Drug: Placebo (for Solifenacin succinate); Drug: Levofloxacin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02094703

URO-SOL-01-2012

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups

levofloxacin and solifenacin succinate

Experimental group

Description:

Levofloxacin 500 mg tablet and solifenacin succinate 5 mg tablet by mouth once daily for 3 days

Treatment:

Drug: Levofloxacin

Drug: Solifenacin succinate

levofloxacin and placebo

Active Comparator group

Description:

Levofloxacin 500 mg tablet and placebo (for solifenacin succinate) by mouth once daily for 3 days

Treatment:

Drug: Levofloxacin

Drug: Placebo (for Solifenacin succinate)