Overactive Bladder Clinical Trial
Official title:
Validation of MenHealth Mobile Uroflowmetry Application
Verified date | March 2021 |
Source | BE Technologies Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study is studying MenHealth Mobile Uroflowmetry as a diagnostic tool for LUTS (lower urinary tract symptoms), a group of conditions involving the bladder, urinary sphincter, urethra and the prostate.
Status | Completed |
Enrollment | 54 |
Est. completion date | February 25, 2021 |
Est. primary completion date | February 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - You have to be a male patient. - You must have a smartphone (iPhone or Android). - For Group 1 (Symptomatic), you are at least 35 years old and have already been diagnosed with BPH or Overactive Bladder (OAB) condition OR you are presenting at least one of the following BPH / OAB symptoms: frequent or urgent need to urinate, increased frequency of urination at night (nocturia), difficulty starting urination, weak urine stream or a stream that stops and starts, dribbling at the end of urination, inability to completely empty the bladder, experience urge incontinence - the involuntary loss of urine immediately following an urgent need to urinate. - For Group 2 (Asymptomatic), you are at least 18 years old and have not been diagnosed with BPH or OAB, and you are not presenting any of the above symptoms. Exclusion Criteria: - Male younger than 18 or older than 90 - Female |
Country | Name | City | State |
---|---|---|---|
United States | Urology of Virginia | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
BE Technologies Inc | Urology of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MenHealth Uroflowmetry application performance | To validate the performance of MenHealth Uroflowmetry application by measuring maximum flow, average flow, and voided volume obtained by MenHealth Uroflowmetry application and comparing this data with corresponding data obtained by a standard office Uroflowmeter. Every individual Uroflowmetry test contains these three parameters ( maximum flow, voided volume, and average flow) as an outcome measure. | 2 weeks |
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