Prostate CancerNCT04488068
Transpelvic Magnetic Stimulation to Improve Urogenital Function
A study of Prostate Cancer and Erectile Dysfunction, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Being tested
- Sham Magnetic stimulation
- Keywords
- urinary incontinence, hemodynamics
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Magnetic stimulationProcedure or surgery
Sham Magnetic stimulation for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Stimulation | Experimental | Patients will be subjected to TPMS. Receives: Procedure: Sham Magnetic stimulation |
| Sham TPMS | No intervention | Patients will be subjected to sham TPMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: During 12-weeks therapy
Patient Retention
Retention of these prostate cancer survivors for the study duration.
Measured: Retention for 12 week study period.
Patient Acceptability
Acceptability of TPMS treatment
Measured: 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
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.
Measured: 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.
Measured: 12 weeks Post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Oct 2020
- Primary completion11 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention to prevent prostate cancer surgery related urological issues
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mahadevan R. Rajasekaran, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488068
- Sponsor's protocol ID
- F3455-P
- Status last verified
- Apr 2024
- First submitted
- 29 Jun 2020
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention toImprove Urogenital Function in Prostate Cancer Survivors
- ClinicalTrials.gov ID
- NCT04488068
- Acronym / sponsor ID
- F3455-P
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Keywords
- urinary incontinence, hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention to prevent prostate cancer surgery related urological issues
| Arm | Type | Receives |
|---|---|---|
| Magnetic Stimulation | Experimental | Procedure: Sham Magnetic stimulationPatients will be subjected to TPMS. |
| Sham TPMS | No intervention | –Patients will be subjected to sham TPMS |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham Magnetic stimulationSham Magnetic stimulation for comparison. | Procedure or surgery | Magnetic Stimulation |
Primary outcome
Number of Participants Recruited
Time frame: During 12-weeks therapy
Primary outcome measure will be to determine feasibility of recruitment of prostate cancer survivors. We will demonstrate recruitment in VASDHS urology clinics .
Patient Retention
Time frame: Retention for 12 week study period.
Retention of these prostate cancer survivors for the study duration.
Patient Acceptability
Time frame: 12 weeks Post-therapy
Acceptability of TPMS treatment
2 secondary outcomes
Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome
Time frame: 12 weeks post-therapy
Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome
Time frame: 12 weeks Post-therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahadevan R. Rajasekaran, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Prostate Cancer and Erectile Dysfunction, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Recruited (time frame: During 12-weeks therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.