The efficacy combined therapy with silodosin and solifenasin in female overactive bladder patients with voiding symptom
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0003202
- Lead Sponsor
- Korea University Ansan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 338
1. Women aged 19 ~79 years
2. OAB patients planned treat with solifenacin
3. OABSS total score = 3,OABSS subscore (Q3)=2 and more than 6 points of Voiding sx subscore (sum of 1,3,5,6 items) on IPSS
4. =3 urgency episodes per 24 h in a 3-day voiding diary
5. Those who have symptoms of overactive bladder symptom for more than 3 months before screening
6. Those who have the ability to write the voiding diary and the questionnaire accurately
7. A person who voluntarily participates in the observation study and agrees in writing to the subject consent form.
1. Patients with acute cystitis.
2. Patients with undergoing alphablocker or anticholinergics.
3. Patients who do not agree with this study.
4. Pregnant and lactating women.
5. Patient with hypersensitivity of TruPass 8 mg or Vesicare 5 mg.
6. Patients with residual urine >200cc
7. Those with a history of acute urinary retention.
8. Patients with acute myocardiac infarction, angina, arrythemia or cardiac pacemaker
9. Those who underwent surgery that could affect urinary function within 24 hours of screening
10. Severe gastrointestinal disease or myasthenia gravis
11. Patients with narrow angle glaucoma
12. patients who treated with hemodialysis
13. Patients with severe renal impairment (CCr <30 ml / min) who have moderate hepatic impairment and are co-administered with potent CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, itraconazole, ritonavir)
14. Those who participated in other interventional clinical trials within 3 months of screening
15. A person who has or has a history of a malignant tumor.
16. Patients with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency, glucose-galactose uptake disorder
17. Any other person who is ineligible to participate in the observational study when the examiner or the examiner judges
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change subscore of IPSS (Voiding symptom score, sum 1,3,5,6)
- Secondary Outcome Measures
Name Time Method Total IPSS score;QoL score on IPSS;Change of OABSS score;Change of Q max in uroflowmetry;safety