N/A
N=12
Transpelvic Magnetic Stimulation to Improve Urogenital Function
Prostate Cancer · Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT04488068 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants Recruited — 12; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sham Magnetic stimulation (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Recruited |
12; 0 | — |
| PRIMARY Patient Retention |
9 | — |
| PRIMARY Patient Acceptability |
9 | — |
| SECONDARY Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome |
9; 0 | — |
| SECONDARY Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome |
9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04488068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.