Back to resultsTranspelvic Magnetic Stimulation to Improve Urogenital Function
Primary Purpose
Prostate Cancer, Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham Magnetic stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring urinary incontinence, hemodynamics
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.
Sites / Locations
- VA San Diego Healthcare System, San Diego, CA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Magnetic Stimulation
Sham TPMS
Arm Description
Patients will be subjected to TPMS.
Patients will be subjected to sham TPMS
Outcomes
Primary Outcome Measures
Improvements in sexual function change
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.
Change in number of pads used as a measure of Improvements in continence function
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
Improvements in penile blood flow change
Penile blood flow will be measured as peak systolic velocity (mm/sec) using laser Doppler method.
Improvements in pelvic muscle thickness change
Muscle thickness (mm) will be measured by anatomical MRI and quantified using imaging software such as Amira.
Change in Pad weight as a measure of Improvements in continence function
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.
Change in urinary symptom score as a measure of Improvements in continence function
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.
Full Information
NCT ID
NCT04488068
First Posted
June 29, 2020
Last Updated
November 4, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04488068
Brief Title
Transpelvic Magnetic Stimulation to Improve Urogenital Function
Official Title
Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention toImprove Urogenital Function in Prostate Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Erectile Dysfunction
Keywords
urinary incontinence, hemodynamics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention to prevent prostate cancer surgery related urological issues
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnetic Stimulation
Arm Type
Experimental
Arm Description
Patients will be subjected to TPMS.
Arm Title
Sham TPMS
Arm Type
No Intervention
Arm Description
Patients will be subjected to sham TPMS
Intervention Type
Procedure
Intervention Name(s)
Sham Magnetic stimulation
Intervention Description
Sham Magnetic stimulation for comparison.
Primary Outcome Measure Information:
Title
Improvements in sexual function change
Description
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.
Time Frame
At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
Title
Change in number of pads used as a measure of Improvements in continence function
Description
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.
Time Frame
At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
Secondary Outcome Measure Information:
Title
Improvements in penile blood flow change
Description
Penile blood flow will be measured as peak systolic velocity (mm/sec) using laser Doppler method.
Time Frame
Penile blood flow (mm/sec) will be measured at baseline and at 4, 8, 12, 13 and 24 weeks post- treatment.
Title
Improvements in pelvic muscle thickness change
Description
Muscle thickness (mm) will be measured by anatomical MRI and quantified using imaging software such as Amira.
Time Frame
Muscle thickness (mm) will be measured at baseline and at 13 weeks post- treatment.
Title
Change in Pad weight as a measure of Improvements in continence function
Description
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.
Time Frame
At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
Title
Change in urinary symptom score as a measure of Improvements in continence function
Description
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.
Time Frame
At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Our proposal is aimed at preventing sexual dysfunction and urinary incontinence in prostate cancer survivors, a gender specific cancer.
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahadevan R. Rajasekaran, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Transpelvic Magnetic Stimulation to Improve Urogenital Function
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