Trial Outcomes & Findings for Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer (NCT NCT03063125)
NCT ID: NCT03063125
Last Updated: 2021-08-03
Results Overview
The count of participants with hypogonadism (the level of serum testosterone used as a threshold).
COMPLETED
25 participants
90 days post-RC surgery
2021-08-03
Participant Flow
Patients were recruited from University of Kansas Medical Center Urology Clinics
Participant milestones
| Measure |
Bladder Cancer Patients
Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
Baseline characteristics by cohort
| Measure |
Bladder Cancer Patients
n=25 Participants
Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=99 Participants
|
|
Age, Continuous
|
68.9 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 90 days post-RC surgeryThe count of participants with hypogonadism (the level of serum testosterone used as a threshold).
Outcome measures
| Measure |
Bladder Cancer Patients
n=16 Participants
Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
|
|---|---|
|
Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical
|
6 participants
|
SECONDARY outcome
Timeframe: 30 days post-RC surgeryThe count of participants with hypogonadism 30 days post radical cystectomy using the serum testosterone levels (the level of serum testosterone used as a threshold).
Outcome measures
| Measure |
Bladder Cancer Patients
n=11 Participants
Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
|
|---|---|
|
The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy
|
8 Participants
|
SECONDARY outcome
Timeframe: Immediately post-operatively RC surgeryThe count of participants with hypogonadism immediately post radical cystectomy based on levels of testosterone (the level of serum testosterone used as a threshold).
Outcome measures
| Measure |
Bladder Cancer Patients
n=20 Participants
Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
|
|---|---|
|
The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline, prior to RC surgeryThe count of participants with hypogonadism at baseline days post radical cystectomy (the level of serum testosterone used as a threshold).
Outcome measures
| Measure |
Bladder Cancer Patients
n=23 Participants
Patients with bladder cancer scheduled to undergo radical cystectomy (RC).
|
|---|---|
|
The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy
|
12 Participants
|
Adverse Events
Bladder Cancer Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place