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

The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Symptomatic Non-complicated Urinary Tract Infection in Females

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02094703
Enrollment
126
Registered
2014-03-24
Start date
2013-04-30
Completion date
2014-12-31
Last updated
2014-03-24

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

Conditions

Urinary Tract Infection

Keywords

female, age 18-65 years, storage symptoms, clinical urinary tract infection, non complicated

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.

Interventions

DRUGLevofloxacin
DRUGSolifenacin succinate
DRUGPlacebo (for Solifenacin succinate)

Sponsors

Astellas Pharma Indonesia Inc.
CollaboratorINDUSTRY
Pharos Life Corporation
CollaboratorINDUSTRY
Dr Cipto Mangunkusumo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of participants with storage symptomsup to three days

Countries

Indonesia

Outcome results

None listed

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