Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention toImprove Urogenital Function in Prostate Cancer Survivors

经盆腔磁刺激作为改善前列腺癌幸存者泌尿生殖功能的新型干预措施的可行性测试

• 批准号: 10249223
• 负责人: MAHADEVAN Raj RAJASEKARAN
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-10-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10249223
• 关键词: Adherence; Affect; Anatomy; Architecture; Atrophic; Bladder Control; Blood; Blood flow; Cancer Survivor; Cicatrix; Clinic; Clinical Trials; Communication; Complex; Consent; Data; Development; Devices; Diagnostic Imaging; Early Diagnosis; Electronic Mail; Ensure; Erectile dysfunction; Evaluation; Feasibility Studies; Fibrosis; Foundations; Functional disorder; Future; Genitourinary system; Healthcare; Image; Imaging Techniques; Incidence; Inflammation; Injury; Institutional Review Boards; International; Intervention; Intervention Studies; Laser Speckle Imaging; Lasers; Lead; Magnetic Resonance Imaging; Magnetism; Male sexual dysfunction; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Methods; Microcirculation; Monitor; Morphology; Muscle; Muscle function; Muscular Atrophy; Nervous System Trauma; Oncology; Operative Surgical Procedures; Outcome; Outcome Measure; Pain-Free; Participant; Patient Recruitments; Patient Schedules; Patients; Pelvic Floor Muscle; Pelvis; Physiological; Pilot Projects; Placebos; Play; Population; Positioning Attribute; Process; Prostate Cancer therapy; Protocols documentation; Quality of life; Questionnaires; Radiology Specialty; Randomized; Randomized Clinical Trials; Recovery; Recovery of Function; Regulation; Rehabilitation therapy; Reporting; Research; Research Personnel; Retropubic Prostatectomy; Risk Factors; Role; Severities; Sex Functioning; Sexual Dysfunction; Smooth Muscle; Sphincter; Striated Muscles; Surgical Injuries; Symptoms; Techniques; Telephone; Testing; Therapeutic; Therapeutic Intervention; Time; Tissues; Training; Translational trial; Urethra; Urethral sphincter; Urinary Incontinence; Urologist; Urology; Vascular blood supply; Veterans; Weight; acceptability and feasibility; age related; base; blood perfusion; cancer surgery; cancer type; clinical application; clinical translation; curative treatments; erection; feasibility testing; follow-up; functional disability; hemodynamics; improved; incontinence symptom; indexing; injury recovery; innovation; male; men; military veteran; muscle regeneration; muscle strength; nerve supply; neuroregulation; non-invasive imaging; novel; novel diagnostics; novel imaging technique; novel strategies; penis; pressure; prevent; primary outcome; programs; prostate cancer survivors; prostate surgery; randomized trial; recruit; regeneration function; relating to nervous system; retention rate; secondary outcome; tool; treatment arm; uptake; urinary

The overall purpose of this SPiRE project is to assess the feasibility and acceptability of a novel intervention approach and to collect preliminary data for a future randomized clinical trial to rehabilitate urogenital function in prostate cancer survivors. Prostate cancer is most common in men over 50 years and this cancer incidence is especially high (29%) in the VA patients. With early diagnosis, patients can pursue potentially curative interventions that include surgical procedures (radical retropubic prostatectomy). However, these surgical treatments lead to problems with continence (urinary incontinence: UI) and sexual function (erectile dysfunction- ED, a major form of sexual dysfunction) in as many as 30-70% of these cancer survivors. Although it is recognized that the continence and sexual functions are critical issues affecting quality of life, there has been only limited research into methods to prevent these forms of dysfunction. These derangements are further impacted by age-related atrophy and fibrosis of corpus cavernosum, urethral sphincters, and that of supporting pelvic floor muscles (ischiocavernosus-ICM and puborectalis-PRM). Hence, there is an urgent need for non-invasive innovative approaches for urinary continence and sexual function rehabilitation to prevent this problem in cancer survivors. This proposed feasibility study takes a novel interventional approach, using repetitive Transpelvic Magnetic Stimulation approach (rTPMS) to prevent fibrosis and strengthen the PFM. We propose to recruit VA patients that are scheduled to undergo prostate cancer surgery and perform a randomized interventional study to determine the feasibility of rehabilitation potential of rTPMS. We will estimate number of potentially eligible patients, rate of consent of eligible patients consent rate, overall uptake rate (in relation to the number potentially eligible), retention rate, follow-up rates for questionnaires and adherence to the interventions and imaging protocols. We will first evaluate all the baseline physiological as well as morphological parameters of penis, urethra and pelvic muscles. Primary outcome measures for assessment of UI will be the extent of reduction (%) in the number of UI symptom scores. For assessment of ED, improvement in erectile function as measured by the International Index of Erectile Function (IIEF-5), a validated, 5-item symptom score, will be used. Secondary outcome measures will be pad weight and PFM changes that will be measured by MRI (UTE for fibrosis). For ED, penile blood flow and PFM changes measured by Doppler blood flow, laser speckle contrast imaging and MRI (UTE for fibrosis), respectively. Besides these therapeutic interventions, we also propose to test novel diagnostic tools to monitor blood supply to the penile tissues (by Laser Doppler imaging) and scarring of these muscles (by a new MRI technique, called ultrashort echo time-UTE). Next, we will test if TPMS will enhance blood flow and increase pelvic muscle strength in these men for about 6 months. Patients will be further monitored for 3 more months and subjected to all the described evaluations to determine recovery of continence and sexual functions. Use of rTPMS to promote continence and sexual function rehabilitation remains unexplored. Thus, our future randomized clinical trials will have the potential to identify novel strategies for restoring continence and sexual function after the surgical treatment in prostate cancer survivors. All the proposed novel non-invasive imaging techniques such as MR-UTE (to monitor fibrosis) and the novel hemodynamic technique to monitor penile microvascular function have high potential for future clinical applications. In addition, the proposed rTPMS protocol has significant potential for clinical translation. If this intervention is proven to be efficacious in a future randomized trial, it will have important implications for rehabilitation in the future. Thus, establishing the foundation for a future translational trial is of utmost importance to VA healthcare users.

The overall purpose of this SPiRE project is to assess the feasibility and acceptability of a novel intervention approach and to collect preliminary data for a future randomized clinical trial to rehabilitate urogenital function in prostate cancer survivors. Prostate cancer is most common in men over 50 years and this cancer incidence is especially high (29%) in the VA patients. With early diagnosis, patients can pursue potentially curative interventions that include surgical procedures (radical retropubic prostatectomy). However, these surgical treatments lead to problems with continence (urinary incontinence: UI) and sexual function (erectile dysfunction- ED, a major form of sexual dysfunction) in as many as 30-70% of these cancer survivors. Although it is recognized that the continence and sexual functions are critical issues affecting quality of life, there has been only limited research into methods to prevent these forms of dysfunction. These derangements are further impacted by age-related atrophy and fibrosis of corpus cavernosum, urethral sphincters, and that of supporting pelvic floor muscles (ischiocavernosus-ICM and puborectalis-PRM). Hence, there is an urgent need for non-invasive innovative approaches for urinary continence and sexual function rehabilitation to prevent this problem in cancer survivors. This proposed feasibility study takes a novel interventional approach, using repetitive Transpelvic Magnetic Stimulation approach (rTPMS) to prevent fibrosis and strengthen the PFM. We propose to recruit VA patients that are scheduled to undergo prostate cancer surgery and perform a randomized interventional study to determine the feasibility of rehabilitation potential of rTPMS. We will estimate number of potentially eligible patients, rate of consent of eligible patients consent rate, overall uptake rate (in relation to the number potentially eligible), retention rate, follow-up rates for questionnaires and adherence to the interventions and imaging protocols. We will first evaluate all the baseline physiological as well as morphological parameters of penis, urethra and pelvic muscles. Primary outcome measures for assessment of UI will be the extent of reduction (%) in the number of UI symptom scores. For assessment of ED, improvement in erectile function as measured by the International Index of Erectile Function (IIEF-5), a validated, 5-item symptom score, will be used. Secondary outcome measures will be pad weight and PFM changes that will be measured by MRI (UTE for fibrosis). For ED, penile blood flow and PFM changes measured by Doppler blood flow, laser speckle contrast imaging and MRI (UTE for fibrosis), respectively. Besides these therapeutic interventions, we also propose to test novel diagnostic tools to monitor blood supply to the penile tissues (by Laser Doppler imaging) and scarring of these muscles (by a new MRI technique, called ultrashort echo time-UTE). Next, we will test if TPMS will enhance blood flow and increase pelvic muscle strength in these men for about 6 months. Patients will be further monitored for 3 more months and subjected to all the described evaluations to determine recovery of continence and sexual functions. Use of rTPMS to promote continence and sexual function rehabilitation remains unexplored. Thus, our future randomized clinical trials will have the potential to identify novel strategies for restoring continence and sexual function after the surgical treatment in prostate cancer survivors. All the proposed novel non-invasive imaging techniques such as MR-UTE (to monitor fibrosis) and the novel hemodynamic technique to monitor penile microvascular function have high potential for future clinical applications. In addition, the proposed rTPMS protocol has significant potential for clinical translation. If this intervention is proven to be efficacious in a future randomized trial, it will have important implications for rehabilitation in the future. Thus, establishing the foundation for a future translational trial is of utmost importance to VA healthcare users.