Trial Outcomes & Findings for Transpelvic Magnetic Stimulation to Improve Urogenital Function (NCT NCT04488068)
NCT ID: NCT04488068
Last Updated: 2024-07-29
Results Overview
Primary outcome measure will be to determine feasibility of recruitment of prostate cancer survivors. We will demonstrate recruitment in VASDHS urology clinics .
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
During 12-weeks therapy
Results posted on
2024-07-29
Participant Flow
Participant milestones
| Measure |
Magnetic Stimulation
Patients will be subjected to TPMS.
Sham Magnetic stimulation: Sham Magnetic stimulation for comparison.
|
Sham TPMS
Patients will be subjected to sham TPMS
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
0
|
|
Overall Study
COMPLETED
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Out of the 12 patients consented, only 9 completed the 12-week treatment.
Baseline characteristics by cohort
| Measure |
Magnetic Stimulation
n=12 Participants
Patients will be subjected to TPMS.
Sham Magnetic stimulation: Sham Magnetic stimulation for comparison. Despite the pandemic related restrictions during the initial study period, we managed to consent 12 and retain nine patients (age 55-75) for this feasibility study
|
Sham TPMS
No patients could be recruited for sham arm
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
0 Participants
n=7 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
0 Participants
n=5 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
0 Participants
n=7 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
6 Participants
n=5 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
0 Participants
n=7 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
6 Participants
n=5 Participants • Out of the 12 patients consented, only 9 completed the 12-week treatment.
|
|
Age, Continuous
|
65 percentage
STANDARD_DEVIATION 5 • n=5 Participants
|
—
|
65 percentage
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants • Out of 12 recruited patients, only 9 completed the 12-week treatment.
|
0 Participants
n=7 Participants • Out of 12 recruited patients, only 9 completed the 12-week treatment.
|
0 Participants
n=5 Participants • Out of 12 recruited patients, only 9 completed the 12-week treatment.
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants • Out of 12 recruited patients, only 9 completed the 12-week treatment.
|
0 Participants
n=7 Participants • Out of 12 recruited patients, only 9 completed the 12-week treatment.
|
12 Participants
n=5 Participants • Out of 12 recruited patients, only 9 completed the 12-week treatment.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
—
|
12 Participants
n=5 Participants
|
|
Patient recruitment
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During 12-weeks therapyPopulation: Prostate cancer survivors with UI and ED.
Primary outcome measure will be to determine feasibility of recruitment of prostate cancer survivors. We will demonstrate recruitment in VASDHS urology clinics .
Outcome measures
| Measure |
Magnetic Stimulation
n=12 Participants
Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.
Sham Magnetic stimulation: Sham Magnetic stimulation for comparison.
|
Sham TPMS
Patients ((prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS
|
|---|---|---|
|
Number of Participants Recruited
|
12 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Retention for 12 week study period.Population: Prostate cancer survivors with UI and ED.
Retention of these prostate cancer survivors for the study duration.
Outcome measures
| Measure |
Magnetic Stimulation
n=12 Participants
Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.
Sham Magnetic stimulation: Sham Magnetic stimulation for comparison.
|
Sham TPMS
Patients ((prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS
|
|---|---|---|
|
Patient Retention
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: 12 weeks Post-therapyPopulation: Prostate cancer survivors with UI and ED.
Acceptability of TPMS treatment
Outcome measures
| Measure |
Magnetic Stimulation
n=9 Participants
Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.
Sham Magnetic stimulation: Sham Magnetic stimulation for comparison.
|
Sham TPMS
Patients ((prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS
|
|---|---|---|
|
Patient Acceptability
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeks post-therapyPopulation: Prostate cancer survivors with UI and ED.
The second objective is to test the feasibility of administering symptom scores in this population to detect severity and early recovery of functional impairment. The investigators will use International Consultation of Incontinence Questionnaire (ICIQ)-symptom score, which assesses the symptoms and effect of UI on quality of life.
Outcome measures
| Measure |
Magnetic Stimulation
n=9 Participants
Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.
Sham Magnetic stimulation: Sham Magnetic stimulation for comparison.
|
Sham TPMS
Patients ((prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS
|
|---|---|---|
|
Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeks Post-therapyPopulation: Prostate cancer survivors with UI and ED.
The second objective is to test the feasibility of administering symptom scores in this population to detect severity and early recovery of functional impairment. The investigators will evaluate The International Index of Erectile Function (IIEF) symptom scores to test the role of these changes in sexual function symptom severity.
Outcome measures
| Measure |
Magnetic Stimulation
n=9 Participants
Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS.
Sham Magnetic stimulation: Sham Magnetic stimulation for comparison.
|
Sham TPMS
Patients ((prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS
|
|---|---|---|
|
Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome
|
9 Participants
|
—
|
Adverse Events
Magnetic Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham TPMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mahadevan Rajasekaran, Ph.D.
VA San Diego Healthcare System
Phone: 8585528585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place