Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

Condition(s) targeted: Urinary Bladder, Overactive; Overactive Bladder

Intervention: Solifenacin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

Overall contact:
Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com

The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.

Official title: Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: percentage of patients who are maintaining solifenacin treatment

Secondary outcome:

percentage of patients who discontinued solifenacin treatment

percentage of patients who switched to other OAB medication

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Overactive bladder symptoms lasting for more than 3 months

- The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum

score of OABSS ≥ 3

- Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency

Perception Scale (UPS)

Exclusion Criteria:

- Any condition that would contraindicate their usage of anticholinergic treatment,

including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis

- Symptomatic acute urinary tract infection (UTI)

- Diagnosed or suspected of interstitial cystitis

- Treatment with anticholinergic drugs for over 3 months within 12 months prior to the

study

- Pregnant or nursing women

- Treatment within the 14 days before the study or expected to initiate treatment

during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs

- Any other condition which, in the opinion of the investigator, makes the patient

unsuitable for inclusion

Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com

Bucheon 420-717, Korea, Republic of; Recruiting

Bucheon 420-767, Korea, Republic of; Recruiting

Busan 602-702, Korea, Republic of; Recruiting

Busan 602-715, Korea, Republic of; Recruiting

Busan 602-739, Korea, Republic of; Recruiting

Busan 614-735, Korea, Republic of; Recruiting

Chonju 361-711, Korea, Republic of; Recruiting

Chonju 380-704, Korea, Republic of; Recruiting

Chuncheon 200-704, Korea, Republic of; Recruiting

Daegu 700-721, Korea, Republic of; Recruiting

Daegu 700-712, Korea, Republic of; Recruiting

Daegu 705-718, Korea, Republic of; Recruiting

Daegu 705-717, Korea, Republic of; Recruiting

Daejeon 302-718, Korea, Republic of; Recruiting

Daejeon 302-799, Korea, Republic of; Recruiting

Daejeon 301-721, Korea, Republic of; Recruiting

Gangneung 201-711, Korea, Republic of; Recruiting

Gumi-si 730-728, Korea, Republic of; Recruiting

Gwangju 503-715, Korea, Republic of; Recruiting

Gwangju 501-757, Korea, Republic of; Recruiting

Gwangju 501-717, Korea, Republic of; Recruiting

Gyongju 780-350, Korea, Republic of; Recruiting

Hwasun 519-809, Korea, Republic of; Recruiting

Iksan 570-160, Korea, Republic of; Recruiting

Inchon 405-760, Korea, Republic of; Recruiting

Inchon 400-711, Korea, Republic of; Recruiting

Jeonju 561-712, Korea, Republic of; Recruiting

Masan 630-522, Korea, Republic of; Recruiting

Seongnam 463-707, Korea, Republic of; Recruiting

Seoul 143-729, Korea, Republic of; Recruiting

Seoul 130-702, Korea, Republic of; Recruiting

Seoul 136-705, Korea, Republic of; Recruiting

Seoul 137-701, Korea, Republic of; Recruiting

Seoul 100-380, Korea, Republic of; Recruiting

Seoul 110-744, Korea, Republic of; Recruiting

Seoul 138-736, Korea, Republic of; Recruiting

Seoul 139-711, Korea, Republic of; Recruiting

Seoul 158-710, Korea, Republic of; Recruiting

Seoul 133-792, Korea, Republic of; Recruiting

Suwon 443-721, Korea, Republic of; Recruiting

Ulsan 682-714, Korea, Republic of; Recruiting

Starting date: August 2009
Last updated: September 25, 2009