Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Prostatic Neoplasms

Erectile Dysfunction

Urinary Incontinence

Enuresis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Sham Magnetic stimulation for comparison.

Sham Magnetic stimulation

Mahadevan R. Rajasekaran, PhD

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.

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.

Intervention to prevent prostate cancer surgery related urological issues

Our proposal is aimed at preventing sexual dysfunction and urinary incontinence in prostate cancer survivors, a gender specific cancer.

Transpelvic Magnetic Stimulation to Improve Urogenital Function

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

Primary outcome measure will be to determine improvements in male sexual (erectile) function after magnetic stimulation therapy.

The objective measure for erectile function will be the International Index of Erectile Function (IIEF), a validated, 5-item symptom-subjective score. These five items focus on male erectile function. Response options are based on rating scales from 1 to 5 and the responses are added to form a total IIEF-5 score from 5 to 25. Lower scores indicate poor sexual function and higher scores after therapy will indicate improvement.

The first objective measure for urinary incontinence (UI) change will be the number of pads used in 24-hours as an index of urine leakage. Higher number of pad use will indicate severe UI and lower number pad use after therapy will indicate improvement.

Penile blood flow will be measured as peak systolic velocity (mm/sec) using laser Doppler method.

Muscle thickness (mm) will be measured by anatomical MRI and quantified using imaging software such as Amira.

The second objective measure for urinary incontinence (UI) change will be the total weight of the pads used in 24-hours as an index of urine leakage. Higher number of pad weight will indicate severe UI and lower number pad use after therapy will indicate improvement.

The third objective measure for urinary incontinence (UI) change will be the change in urinary symptom scores. The investigators will use International Consultation of Incontinence Questionnaire (ICIQ)-symptom score (scores range: 0-21), a score which assesses the symptoms and effect of UI on quality of life. Higher scores will indicate severe UI and lower scores after therapy will indicate improvement.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Transpelvic Magnetic Stimulation to Improve Urogenital Function	NCT04488068	Prostate Cancer Erectile Dysfun...	Sham Magnetic s...	50 Years - 80 Years	VA Office of Research and Development
Transpelvic Magnetic Stimulation to Improve Urogenital Function	NCT04488068	Prostate Cancer Erectile Dysfun...	Sham Magnetic s...	50 Years - 80 Years	VA Office of Research and Development

Spots Global Cancer Trial Database for sham magnetic stimulation