Reproducibility Study of OABSS and Its Response to Treatment (RESORT part 2)

Astellas

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Solifenacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02667470

ATH-002

Details and patient eligibility

About

The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At screening visit (Week -2):

  • Symptoms of OAB ≥ 3 months
  • Number of urgency episodes in last 3 days ≥ 3

• Based on the 3-day micturition diary prior to Visit 1 (Week 0):

  • Number of micturition per day ≥ 8
  • Number of urgency episodes in 3 days ≥ 3

Exclusion criteria

• At screening visit (Week -2):

  • Stress is the predominant factor as determined by the investigator
  • Indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Treatment for OAB was started, quitted or changed in 4 weeks
  • Diabetic neuropathy

• At Visit 1 (Week 0):

  • Patient who did not complete the 3-day micturition diary according to the instruction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Solifenacin

Experimental group

Treatment:

Drug: Solifenacin