Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention toImprove Urogenital Function in Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Patient Retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patient Retention
时间窗: Retention for 12 week study period.
Retention of these prostate cancer survivors for the study duration.
Patient Acceptability
时间窗: 12 weeks Post-therapy
Acceptability of TPMS treatment
Number of Participants Recruited
时间窗: 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 .
次要结局
- Number of Participants Who Completed the The International Consultation on Incontinence Questionnaire (ICIQ) to Determine Feasibility to Determine Treatment Outcome(12 weeks post-therapy)
- Number of Participants Who Completed the The International Index of Erectile Function (IIEF) to Determine Feasibility to Determine Treatment Outcome(12 weeks Post-therapy)