NCT04488068

Transpelvic Magnetic Stimulation to Improve Urogenital Function

Completed NA Results posted Last updated 29 July 2024

What this trial tests

NA trial testing Sham Magnetic stimulation in Prostate Cancer in 12 participants. Completed in 30 September 2022.

Timeline

1 October 2020

Primary endpoint
11 August 2022

30 September 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	12
Start date	1 October 2020
Primary completion	11 August 2022
Estimated completion	30 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Sham Magnetic stimulation

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Erectile Dysfunction — all drugs for Erectile Dysfunction →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 50 to 80, male only, with Prostate Cancer or Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Recruited Primary · 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 .

Group	Value	95% CI
Magnetic Stimulation	12
Sham TPMS	0

Patient Retention Primary · Retention for 12 week study period.

Retention of these prostate cancer survivors for the study duration.

Group	Value	95% CI
Magnetic Stimulation	9

Patient Acceptability Primary · 12 weeks Post-therapy

Acceptability of TPMS treatment

Group	Value	95% CI
Magnetic Stimulation	9

Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome Secondary · 12 weeks post-therapy

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.

Group	Value	95% CI
Magnetic Stimulation	9
Sham TPMS	0

Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome Secondary · 12 weeks Post-therapy

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.

Group	Value	95% CI
Magnetic Stimulation	9

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.