Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05654974 |
Other study ID # |
0000187 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2019 |
Est. completion date |
January 31, 2021 |
Study information
Verified date |
December 2022 |
Source |
University Medical Center, Kazakhstan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Purpose: to assess in Kazakh adult males erect penis sizes, and study an influence of their
natural physiological events and behavioral habits during their growing ages on their penile
sizes nowadays.
Study Design: An observational cross-sectional survey pilot study using a correlational
design with the intention-to-treat principle.
Description:
Participants. A total of 282 adult Kazakh males from the Republic of Kazakhstan and who have
been visited at the urology units of three university centers in the biggest cities of the
Republic of Kazakhstan (Astana, Almaty, and Karaganda) were prospectively included in the
study, which took place between January 2020 and January 2021.
Measurements of the penis erect length and girth were by two doctor-urologists according to
the method of Veale D et al. (2015).
Statistical analysis. Two-tailed Student's t-test, Pearson correlation and multivariate tests
of the MANOVA and MANCOVA (body height as covariate) were used.
Sample size estimation. In a cross-sectional observational study in assessment of erect penis
size of Kazakh adult males we supposed that the primary interest lies in assessment of erect
penis sizes in the three cities (k=3). The investigators wish to be 95% sure of detecting
when the mean erect penis sizes not exceed 1 mm (i.e., 1-β=0.95, and m1=1, m2=0). The
standard deviation of erect penis size is likely to be 1.56 mm (i.e. SD=1.56) with a
statistical power of 95% and significance level of 2.5% with the Bonferroni correction based
on one-sided hypothesis testing. At the 5% Type I error rate (i.e., α=0.05), the sample size
of the survey is 196.