Transpelvic Magnetic Stimulation to Improve Urogenital Function

NCT04488068 | Completed Results

• 1 other identifier: F3455-P
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer; Erectile Dysfunction

Keywords

urinary incontinence; hemodynamics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome

  12 weeks post-therapy

• Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome

  12 weeks Post-therapy

Study Arms (2)

Magnetic Stimulation

EXPERIMENTAL

Patients will be subjected to TPMS.

Procedure: Sham Magnetic stimulation

Sham TPMS

NO INTERVENTION

Patients will be subjected to sham TPMS

Interventions

Sham Magnetic stimulation PROCEDURE

Sham Magnetic stimulation for comparison.

Magnetic Stimulation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Our proposal is aimed at preventing sexual dysfunction and urinary incontinence in prostate cancer survivors, a gender specific cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a feasibility study focused on recruitment and retention, and we did not focus on efficacy.

Results Point of Contact

• Title: Mahadevan Rajasekaran, Ph.D.
• Organization: VA San Diego Healthcare System

Mahadevan.Rajasekaran@VA.gov

8585528585

Study Officials

• Mahadevan R. Rajasekaran, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Intervention to prevent prostate cancer surgery related urological issues

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 27, 2020
• Study Start: October 1, 2020
• Primary Completion: August 11, 2022
• Study Completion: September 30, 2022
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)