Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372704
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-04-09
Brief Title:
Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence
Sponsor:
Kirsehir Ahi Evran Universitesi
Organization:
Kirsehir Ahi Evran Universitesi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIFEM for PPI
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 patients 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 subjects posture and confirmed it using the devices 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 individuals quality of life A minimum of a 50 overall enhancement in the total score was anticipated10 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 Students paired t-test and Wilcoxon signed rank test were used if the sample size was small the significance level was set at p 005 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 005
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 individuals quality of life A minimum of a 50 overall enhancement in the total score was anticipated10 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 Students paired t-test and Wilcoxon signed rank test were used if the sample size was small the significance level was set at p 005 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None