Investigations of the changes in overactive bladder symptoms after the discontinuation of drug for overactive bladder in benign prostatic hyperplasia patients with coexisting overactive bladder

Changes in overactive bladder symptoms after withdrawl of solifenacin following intitial 12-week combination therapy with tamsulosin: A multicenter prospective study in men with benign prostatic hyperplasia and coexisting overactive bladder

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000392

Enrollment

120

Registered

2012-03-28

Start date

2009-04-10

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 : All patients enrolled will be initially treated with o.2mg of tamsulosin plus 5mg of solifenacin once a day. After 12 weeks of intial combination therapy, all patients will switch to tamsulosin

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Elligible patients are men 45 years or older with a total International Prostate Symptom Score (IPSS) of 8 or higher, a total overactive bladder symptoms score (OABSS) of 3 or higher and a score of 3rd item (urgency) of the OABSS of at least 2, and findings suggestive of BPH on transrectal ultrasonography.

Exclusion criteria

Exclusion criteria: Those with acute urinary tract infection, significant renal dysfunction, significant hepatic dysfunction, a history of stroke or Parkinsonism, or a history of prostate cancer or PSA of 10ng/ml or more will be excluded. And those with postvoid residual urine (PVR) more than 100ml, or maximum flow rate less than 8ml/s will be excluded

Design outcomes

Primary

Measure	Time frame
OABSS (overactive bladder symptoms score);PPBC (the patient perception of bladder condition);storage symptom score of IPSS (international prostate symptom score);QOL score	—

Secondary

Measure	Time frame
total micturitions per 24 hours on frequency-volume chart;micturitions per night on frequency-volume chart;functional bladder capacity on frequency-volume chart;voiding symptom score of IPSS;maximum flow rate on uroflowmetyr;postvoid residual urine;patients' intention of resuming administration of solifenacin;adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactSang Wook Lee

Kangwon National University

Outcome results