Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence?

NCT06372704 | Completed FDA Device

• 1 other identifier: 2024/72
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary incontinence after radical prostatectomy surgery is a common condition that negatively affects daily life. Patients often experience discomfort due to urine leakage and the resulting need to use pads daily. This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic technology used therapeutically in patients with urinary incontinence after radical prostatectomy.

Conditions

Prostate Cancer; Incontinence; Pelvic Floor Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• This study demonstrated the safe and effective use of HIFEM technology to prevent PPI by strengthening the pelvic floor muscles in a variety of patients.

  The average International Consultation on Incontinence Questionnaire-Short Form score was calculated before and after the treatment. Their average "pads used per day" was calculated before and after the treatment. The scores and pads' numbers were compared statistically.

  One month.

Study Arms (1)

post prostatectomy incontinence

Twenty-seven patients who underwent radical prostatectomy with a mean age of 67.90 ± 3.40, and who had continuous UI complaints, were included in the study.

Device: HIFEM

Interventions

HIFEM DEVICE

All patients had a total of 6 sessions lasting 28 minutes, twice a week, sitting on an electromagnetic chair (BTL EMSELLA®, BTL Industries Inc, Boston, MA, USA).

post prostatectomy incontinence

Eligibility Criteria

• Age: 63 Years - 70 Years
• Gender Eligibility Details: Twenty-seven patients who underwent radical prostatectomy with a mean age of 67.90 ± 3.40, and who had continuous UI complaints, were included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent radical prostatectomy with a mean age of 67.90 ± 3.40, and who had continuous UI complaints, without pacemakers, metal implants in the spinal cord, blood circulation disorders, fever, and tumors.

You may qualify if:

• patients who underwent radical prostatectomy
• patients who had continuous UI complaints

You may not qualify if:

• Men with pacemakers, metal implants in the spinal cord, blood circulation disorders, fever, and tumors

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

İbrahim Üntan

Kirşehi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 18, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 5, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

TU (1)