Clinical trial NCT06372704: Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence?
Official title: Urinary Incontinence After Radical Prostatectomy Surgery is a Common Condition That Negatively Affects Daily Life. 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. Our Study Has Shown That High-intensity Focused Electromagnetic Technology Can Safely and Effectively Treat Male Patients Suffering From Urinary Incontinence After Prostatectomy. In Addition, no Major Side Effects Were Observed in Patients After Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Incontinence
Pelvic Floor Muscle Weakness
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 27
Sex: MALE
Minimum age (years): 63
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Patients who underwent radical prostatectomy and who had continuous UI complaints, were included in the study. Informed consent forms were obtained from all volunteer patients before the procedure. Data was collected pre- and post-treatment. 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). According to the procedure, all patients remained fully clothed throughout the entire process. To ensure adequate PFM stimulation, the operator confirmed the patient's chair posture throughout the treatments and adjusted the intensity of stimulus as high as tolerated by the patient, usually at 100%. Ensuring the correct positioning is crucial for maximizing therapy effectiveness, so the therapist supervised the subject's posture and confirmed it using the device's positioning system to attain the best possible PFM contractions. Men with pacemakers, metal implants in the spinal cord, blood circulation disorders, fever, and tumors were excluded from the study.

The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was employed to evaluate each patients' continence. The questionnaire comprises three inquiries aimed at measuring how often leakage occurs, the volume of urine leaked, and the extent of disruption to daily activities. Scores on the questionnaire range from 0 (indicating no disruption) to 21 (representing significant involuntary urination affecting the individual's quality of life). A minimum of a 50% overall enhancement in the total score was anticipated(10). Participants were requested to mark the provided responses that applied to their situation, and alterations in their responses over time were assessed. Regarding the quality of life for the patient, the utilization of absorbent pads (per 24-hour cycle) was tracked using a questionnaire specifically designed for pad usage. Data on the primary outcome were collected before the first therapy, upon completion of the sixth therapy session, and at the first-month follow-up. Adverse events were monitored throughout the entire study. The assessment of observed side effects included the following in the treated area: muscle pain, temporary muscle spasms, temporary joint or tendon pain, local redness, or skin redness. The results were analyzed for statistical significance. H0 (null hypothesis) was formulated as follows: "The treatments did not make any difference in the patients' scores." To evaluate the significance of differences caused by treatments (alternative hypothesis), Student's paired t-test and Wilcoxon signed rank test were used if the sample size was small, the significance level was set at p = 0.05. A sample size of 27 individuals was considered sufficient to demonstrate clinically significant improvement for this single-arm retrospective study. The potential relationship between the measured variables was confirmed using the Pearson correlation coefficient (p = 0.05).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: One month.
Secondary outcomes:
Other outcomes:
Locations:
city: Kirşehi̇r
country: Turkey
facility: İbrahim Üntan
Study officials:
References: