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The efficacy combined therapy with silodosin and solifenasin in female overactive bladder patients with voiding symptom

The efficacy combined therapy with silodosin and solifenasin in female overactive bladder patients with voiding symptom

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003202
Enrollment
338
Registered
2018-09-20
Start date
2018-10-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : Patients with OAB and voidng symptoms were treated with antimuscarinic Vesicare 5 mg (Solifenacin Succinate 5 mg) once daily and with antimuscarinic Vesicare 5 mg (Solifenacin Succinate 5 mg) a

Sponsors

Korea University Ansan Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Change subscore of IPSS (Voiding symptom score, sum 1,3,5,6)

Secondary

MeasureTime frame
Total IPSS score;QoL score on IPSS;Change of OABSS score;Change of Q max in uroflowmetry;safety

Countries

Korea, Republic of

Contacts

Public ContactBum Sik Tae

Korea University Ansan Hospital

bumsik4ever@hanmail.net+82-31-412-5191

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026