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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Stimulation | Experimental | Patients will be subjected to TPMS. |
|
| Sham TPMS | No Intervention | Patients will be subjected to sham TPMS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Magnetic stimulation | Procedure | Sham Magnetic stimulation for comparison. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Our proposal is aimed at preventing sexual dysfunction and urinary incontinence in prostate cancer survivors, a gender specific cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Mahadevan R. Rajasekaran, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnetic Stimulation | Patients will be subjected to TPMS. Sham Magnetic stimulation: Sham Magnetic stimulation for comparison. |
| FG001 | Sham TPMS | Patients will be subjected to sham TPMS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Prostate cancer survivors with symptoms of urinary incontinence and erectile dysfunction
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnetic Stimulation | Patients will be subjected to TPMS. Sham Magnetic stimulation: Sham Magnetic stimulation for comparison. Despite the pandemic related restrictions during the initial study period, we managed to consent 12 and retain nine patients (age 55-75) for this feasibility study |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Out of the 12 patients consented, only 9 completed the 12-week treatment. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 . | Prostate cancer survivors with UI and ED. | Posted | Count of Participants | Participants | During 12-weeks therapy |
|
Adverse events were recorded throughout the 12-week treatment period.
Patients were asked to report any adverse effect using the Likert scale.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnetic Stimulation | Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to TPMS. Sham Magnetic stimulation: Sham Magnetic stimulation for comparison. All patients were comfortable with the therapy and reported no adverse effects. |
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This is a feasibility study focused on recruitment and retention, and we did not focus on efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mahadevan Rajasekaran, Ph.D. | VA San Diego Healthcare System | 8585528585 | 7114 | Mahadevan.Rajasekaran@VA.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2020 | Sep 20, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 23, 2020 | Aug 17, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007172 | Erectile Dysfunction |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Intervention to prevent prostate cancer surgery related urological issues
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| 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 |
| Sham TPMS |
No patients could be recruited for sham arm |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Information is collected using periodic personal interviews and questionnaires. | Mean | Standard Deviation | percentage |
|
| Sex: Female, Male | The investigators measured symptoms of urine leakage and erectile dysfunction. | Out of 12 recruited patients, only 9 completed the 12-week treatment. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Patient recruitment | Count of Participants | Participants |
|
|
|
| Primary | Patient Retention | Retention of these prostate cancer survivors for the study duration. | Prostate cancer survivors with UI and ED. | Posted | Count of Participants | Participants | Retention for 12 week study period. |
|
|
|
| Primary | Patient Acceptability | Acceptability of TPMS treatment | Prostate cancer survivors with UI and ED. | Posted | Count of Participants | Participants | 12 weeks Post-therapy |
|
|
|
| Secondary | 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. | Prostate cancer survivors with UI and ED. | Posted | Count of Participants | Participants | 12 weeks post-therapy |
|
|
|
| Secondary | 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. | Prostate cancer survivors with UI and ED. | Posted | Count of Participants | Participants | 12 weeks Post-therapy |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Sham TPMS | Patients (prostate cancer survivors; with symptoms of urinary incontinence and erectile dysfunction) will be subjected to sham TPMS. No record of any adverse events as there were no patients in this arm. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |