Prostate CancerHIFEM for PPINCT06372704
Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence?
An observational study of Prostate Cancer and Incontinence, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 63 to 70 years, men only
- Conditions the study is for
- Prostate Cancer, Incontinence, Pelvic Floor Muscle Weakness
- What is being tested?
- HIFEM
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 5 Apr 2024
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 63 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients who underwent radical prostatectomy
- patients who had continuous UI complaints
Who cannot join
- Men with pacemakers, metal implants in the spinal cord, blood circulation disorders, fever, and tumors
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Prostate Cancer, Incontinence, Pelvic Floor Muscle Weakness
- Being tested
- HIFEM
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFEMDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HIFEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Feb 2024
- Primary completion1 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Untan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372704
- Sponsor's protocol ID
- 2024/72
- Acronym
- HIFEM for PPI
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06372704
- Acronym / sponsor ID
- HIFEM for PPI / 2024/72
- Conditions
- Prostate Cancer, Incontinence, Pelvic Floor Muscle Weakness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post prostatectomy incontinence | – | Device: HIFEMTwenty-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. |
Who may qualify
- Ages
- 63 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients who underwent radical prostatectomy
- patients who had continuous UI complaints
Key exclusion criteria (1 listed)
- Men with pacemakers, metal implants in the spinal cord, blood circulation disorders, fever, and tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFEMAll 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). | Device | post prostatectomy incontinence |
Primary outcome
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.
Time frame: One month.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Incontinence, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: One month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.