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Transpelvic Magnetic Stimulation to Improve Urogenital Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04488068
Recruitment Status : Enrolling by invitation
First Posted : July 27, 2020
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Erectile Dysfunction Procedure: Sham Magnetic stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention to prevent prostate cancer surgery related urological issues
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention toImprove Urogenital Function in Prostate Cancer Survivors
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Improvements in sexual function change [ Time Frame: At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy ]

    Primary outcome measure will be to determine improvements in male sexual (erectile) function after magnetic stimulation therapy.

    The objective measure for erectile function will be the International Index of Erectile Function (IIEF), a validated, 5-item symptom-subjective score. These five items focus on male erectile function. Response options are based on rating scales from 1 to 5 and the responses are added to form a total IIEF-5 score from 5 to 25. Lower scores indicate poor sexual function and higher scores after therapy will indicate improvement.


  2. Change in number of pads used as a measure of Improvements in continence function [ Time Frame: At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy ]
    The first objective measure for urinary incontinence (UI) change will be the number of pads used in 24-hours as an index of urine leakage. Higher number of pad use will indicate severe UI and lower number pad use after therapy will indicate improvement.


Secondary Outcome Measures :
  1. Improvements in penile blood flow change [ Time Frame: Penile blood flow (mm/sec) will be measured at baseline and at 4, 8, 12, 13 and 24 weeks post- treatment. ]
    Penile blood flow will be measured as peak systolic velocity (mm/sec) using laser Doppler method.

  2. Improvements in pelvic muscle thickness change [ Time Frame: Muscle thickness (mm) will be measured at baseline and at 13 weeks post- treatment. ]
    Muscle thickness (mm) will be measured by anatomical MRI and quantified using imaging software such as Amira.

  3. Change in Pad weight as a measure of Improvements in continence function [ Time Frame: At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy ]
    The second objective measure for urinary incontinence (UI) change will be the total weight of the pads used in 24-hours as an index of urine leakage. Higher number of pad weight will indicate severe UI and lower number pad use after therapy will indicate improvement.

  4. Change in urinary symptom score as a measure of Improvements in continence function [ Time Frame: At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy ]
    The third objective measure for urinary incontinence (UI) change will be the change in urinary symptom scores. The investigators will use International Consultation of Incontinence Questionnaire (ICIQ)-symptom score (scores range: 0-21), a score which assesses the symptoms and effect of UI on quality of life. Higher scores will indicate severe UI and lower scores after therapy will indicate improvement.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Our proposal is aimed at preventing sexual dysfunction and urinary incontinence in prostate cancer survivors, a gender specific cancer.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488068


Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Mahadevan R. Rajasekaran, PhD VA San Diego Healthcare System, San Diego, CA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04488068    
Other Study ID Numbers: F3455-P
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
urinary incontinence
hemodynamics
Additional relevant MeSH terms:
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Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders