Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06372704 |
| Other study ID # |
2024/72 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
April 5, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Kirsehir Ahi Evran Universitesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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).
