Transpelvic Magnetic Stimulation to Improve Urogenital Function

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488068
• Other study ID #: F3455-P
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 30, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Sham Magnetic stimulation
Sham Magnetic stimulation for comparison.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in sexual function change	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.	At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
Primary	Change in number of pads used as a measure of Improvements in continence function	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.	At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
Secondary	Improvements in penile blood flow change	Penile blood flow will be measured as peak systolic velocity (mm/sec) using laser Doppler method.	Penile blood flow (mm/sec) will be measured at baseline and at 4, 8, 12, 13 and 24 weeks post- treatment.
Secondary	Improvements in pelvic muscle thickness change	Muscle thickness (mm) will be measured by anatomical MRI and quantified using imaging software such as Amira.	Muscle thickness (mm) will be measured at baseline and at 13 weeks post- treatment.
Secondary	Change in Pad weight as a measure of Improvements in continence function	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.	At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
Secondary	Change in urinary symptom score as a measure of Improvements in continence function	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.	At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy