Transpelvic Magnetic Stimulation to Improve Urogenital Function

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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Prostate Cancer
• Intervention / Treatment: Procedure: Sham Magnetic stimulation

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 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.

The secondary outcome measures: Change in number of pads used as a measure of Improvements in continence function, Improvements in penile blood flow change, Improvements in pelvic muscle thickness change, Change in Pad weight as a measure of Improvements in continence function; were changed/replaced by secondary outcome measures that clearly align with the proposed aims of the study as follows: 1) To show the feasibility of recruitment of prostate cancer survivors, acceptability of Transpelvic magnetic Stimulation (TPMS) intervention, and retention of this Veteran population, we will demonstrate recruitment in VA SAN DIEGO HEALTH CARE SYSTEM (VASDHS) urology clinics and retention of these patients for the study duration. 2) To test the feasibility of administering symptom scores in this population to detect severity and early recovery of functional impairment. 3) To test the feasibility of diagnostic imaging to establish: penile/ pelvic floor muscle (PFM) blood flow, PFM anatomical and morphological changes before surgery, immediately after surgery, and after TPMS interventions.

The third aim of the study was not feasible as the study was performed during the pandemic. Therefore, the outcome measures: Improvements in penile blood flow change and Improvements in pelvic muscle thickness change were removed. The secondary outcome measures were to test the feasibility of administering symptom scores in this population of prostate cancer survivors (not efficacy). Therefore, the outcome measures: Change in number of pads used as a measure of Improvements in continence function and Change in Pad weight as a measure of Improvements in continence function were removed. The secondary outcome measures were changed to the current outcome measures: Number of Patients that completed The International Consultation on Incontinence Questionnaire (ICIQ) scores (as a measure of urinary incontinence; UI ) and Number of Patients that completed The International Index of Erectile Function (IIEF; as a measure of erectile dysfunction; ED) scores as these measures directly align with our study aims. Final monitoring at 24 weeks also was not feasible, so the outcome measure time frame was 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnetic Stimulation; Patients will be subjected to TPMS.	Procedure: Sham Magnetic stimulation; Sham Magnetic stimulation for comparison.
No Intervention: Sham TPMS; Patients will be subjected to sham TPMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Recruited	Primary outcome measure will be to determine feasibility of recruitment of prostate cancer survivors. We will demonstrate recruitment in VASDHS urology clinics .	During 12-weeks therapy
Patient Retention	Retention of these prostate cancer survivors for the study duration.	Retention for 12 week study period.
Patient Acceptability	Acceptability of TPMS treatment	12 weeks Post-therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome	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.	12 weeks post-therapy
Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome	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.	12 weeks Post-therapy

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Mahadevan R. Rajasekaran, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: hemodynamics; urinary incontinence
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Erectile Dysfunction
• Other Study ID Numbers: F3455-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No