Status:
COMPLETED
Transpelvic Magnetic Stimulation to Improve Urogenital Function
Lead Sponsor:
VA Office of Research and Development
Conditions:
Prostate Cancer
Erectile Dysfunction
Eligibility:
MALE
50-80 years
Phase:
NA
Brief Summary
After recruitment, 20 male patients will be assigned 1:1 to either age-matched control (G1: sham) or age-matched intervention (G2: pelvic magnetic stimulation; TPMS) groups using computer-generated pr...
Detailed Description
The investigators will use a custom TPMS device that targets pelvic muscles. The investigators will apply low amplitude (5%) TPMS to improve blood flow, then high amplitude (30-50%) to strengthen pelv...
Eligibility Criteria
Inclusion
- men over 50 years old who are enrolled for prostate surgery,
- have serum testosterone within normal limits, and
- are without prior bilateral orchiectomy, chemotherapy, external radiotherapy, brachytherapy, surgical, or other ablative therapy for prostate cancer.
Exclusion
- patients with ED caused by psychological, neurogenic (after non-nerve sparing prostate surgery), or hormonal disorders,
- patients with genital abnormalities precluding intercourse, prior penile implantation, ongoing erectile aid use, or use of nitrate medications.
- Androgen suppression within the past 6 months or as part of protocol-specified radiotherapy or brachytherapy will be excluded.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04488068
Start Date
October 1 2020
End Date
September 30 2022
Last Update
July 29 2024
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161