Clinical Trial for the Evaluation of the Efficacy and Safety of SFE on Voiding Functio
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0005752
- Lead Sponsor
- BIO-FD&C
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Subjects between 35 ~ 75 years of age
2) Overactive bladder symptoms(frequency of urination more than 8 times a day with urinary urgency and nocturia(0~4 times)) that last longer than one month
3) Subject with overactive bladder symptoms(frequency of urination more than 8 times a day with urinary urgency and nocturia(0~4 times)) in visit2 urination diary
4) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
1) Subject with severe cerebrovascular disease (infarct, hemorrage), cardiac disease (angina, myocardiac infarct, heart failure, arrhythmias that require treatment). (If that patient's clinical status is stable, they can participate in the clinical trial according to investigator)
2) Subject with bladder tumor, bladder outlet obstruction, urinary stone, urethral stricture, bladder neck contracture, lower urinary tract(bladder, urethra) inflammation, urinary tuberculosis, benign prostatic hyperplasia(Prostate volume over 35cc)
3) Subject who have taken drugs that affect urination function within 3 months of visit1
4) Subject who have received treatment that affect urination function within 30 days of visit1
5) Subject who undergone stress incontinence surgery
6) Subject who residual urine over 150 mL
7) Unregulated diabetic patients(fasting blood sugar over 180 mg/dL )
8) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization)
9) Subject who TSH = 0.1 µU/ml or = 10 µU/ml
10) Subject who more than 2 times the upper limit of normal Creatinine of clinical trial institution
11) Subject who more than 3 times the upper limit of normal AST(GOT) or ALT(GPT) of clinical trial institution
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method urinary frequency
- Secondary Outcome Measures
Name Time Method urinary volume, urinary urgency, urinary incontinence;uroflow(maximum, average);residual urine;Modified Overactive Bladder-Validated 8-question Screener(OAB-V8);International Prostate Symptom Score(IPSS);5-item version of the International Index of Erectile Function(IIEF-5);Estradiol;High sensitivity C-reactiveprotein(hs-CRP);urine Nerve Growth Factor(urine NGF);Overactive Bladder Symptom Score(OABSS);urine Prostaglandin E(urine PGE);urine Adenosine Triphosphate(urine ATP);urinary urgency;urinary incontinence