Clinical trial NCT04488068: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Erectile Dysfunction
Keywords: urinary incontinence
hemodynamics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-07-27
Enrollment: 12
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention to prevent prostate cancer surgery related urological issues
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Number of Participants Recruited
timeFrame: During 12-weeks therapy
measure: Patient Retention
timeFrame: Retention for 12 week study period.
measure: Patient Acceptability
timeFrame: 12 weeks Post-therapy
Secondary outcomes:
measure: Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome
timeFrame: 12 weeks post-therapy
measure: Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome
timeFrame: 12 weeks Post-therapy
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Mahadevan R. Rajasekaran, PhD
role: PRINCIPAL_INVESTIGATOR
References: