Clinical Trial for the Evaluation of the Efficacy and Safety of SFE on Voiding Function

A 12 week, Multi-Center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of SFE on Voiding Function

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005752

Enrollment

100

Registered

2021-01-08

Start date

2020-07-07

Completion date

Unknown

Last updated

2021-01-28

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

Conditions

None listed

Interventions

Dietary Supplement : Subjects will be randomized to receive test group or Placebo. Subjects will take 1 tablet at a time, twice a day for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
urinary frequency	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Korea, Republic of

Contacts

Public ContactSoon Chul Myung

Chung-Ang Univerisity Hospital

Outcome results