Summary

Eligibility
for males ages 50-80 (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by Mahadevan R. Rajasekaran, PhD

Description

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.

Official Title

Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention to Improve Urogenital Function in Prostate Cancer Survivors

Details

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.

Keywords

Prostate Cancer Erectile Dysfunction urinary incontinence hemodynamics Prostatic Neoplasms Magnetic Stimulation

Eligibility

You can join if…

Open to males ages 50-80

  • 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.

You CAN'T join if...

  • 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.

Location

  • VA San Diego Healthcare System, San Diego, CA
    San Diego California 92161 United States

Lead Scientist at UCSD

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT04488068
Study Type
Interventional
Last Updated