Prostate Cancer Clinical Trial
Transpelvic Magnetic Stimulation to Improve Urogenital Function
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 process, and baseline parameters will be established. All patients will be instructed by the investigators to perform standard of care pelvic floor exercise for the duration of the study. In addition, G2 patients will receive TPMS, while G1 patients will undergo sham treatment.
Full 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 pelvic muscles. The treatment regimen will involve two 20-minute sessions/visit and 2 -visits per week for 12-weeks (final monitoring at 24 weeks). TPMS will be administered by a trained clinical coordinator under the supervision of a urologist. Symptom scores and hemodynamic changes will be evaluated monthly. MRI for assessing muscle thickness will be performed in the beginning (before TPMS) and at the end (after TPMS) of the study. The investigators will assess functional improvements using symptom scores. Morphological changes will be determined by MRI.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There is 1 Location for this study
San Diego California, 92161, United States
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