Prostate NeoplasmNCT02485665
Efficacy of Extracorporeal Biofeedback Device for Post-prostatectomy Incontinence
A study testing Extracorporeal biofeedback device (Any Kegel) in people with Prostate Neoplasm and Prostatectomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence Read more about this study
- Who is it for?
- Ages 20 to 85 years, men only
- Conditions the study is for
- Prostate Neoplasm, Prostatectomy, Surgical Procedures, Robotic
- What is being tested?
- Extracorporeal biofeedback device (Any Kegel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- 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 20 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer patients who underwent robotic radical prostatectomy
- Neurovascular saving at least one side
- Bladder neck reconstruction at prostatectomy
- Posterior reconstruction at prostatectomy
- Patients who have post-prostatectomy incontinence after Foley catheter removal
Who cannot join
- Patients who have not post-prostatectomy incontinence after Foley catheter removal
- Neurological deficits
- Anatomic deformities of pelvic bone
- Pelvic irradiation history
- History of other major urological procedures
- Complications influencing urinary incontinence
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongam City, Gyeonggi-do, 463-707
Seok-Soo Byun, M.D.,Ph.D., 031-787-7342, ssbyun@snubh.org
About this study
Official title: Efficacy of Personalized Extracorporeal Biofeedback Device for Pelvic Floor Muscle Training on Post-prostatectomy Incontinence
To evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence
Read the detailed description
- Post prostatectomy urinary incontinence (PPI) was common complication after radical prostatectomy among prostate cancer patients.
- The prevalence of post-prostatectomy urinary incontinence was reported at 87%.
- The pelvic floor muscle therapy (PFMT) using Kegel exercise was first methods to prevent PPI after prostatectomy.
- However, there was no standardized protocol of the PFMT and it was necessary of biofeedback to PFMT.
- Therefore, we hypothesis the efficacy of personalized device of PFMT with biofeedback among patients who underwent radical prostatectomy
- In this study, we evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence.
- Conditions
- Prostate Neoplasm, Prostatectomy, Surgical Procedures, Robotic, Urinary Incontinence, Biofeedback, Pelvic Floor
- Being tested
- Extracorporeal biofeedback device (Any Kegel)
- Keywords
- Prostate cancer, Robot-assisted laparoscopic surgery, Radical prostatectomy, Post-prostatectomy incontinence, Pelvic floor muscle exercise, Extracorporeal biofeedback device
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal biofeedback device (Any Kegel)Device
Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. Enrolled patients in intervention group should be performed PFME regularly, based on following protocols: total exercise time (10 minutes/day), intensity (1.2 kgf), tension duration (10 sec/ 1 contraction), total exercise number (4 times/day)
| Study group | Role | What they receive |
|---|---|---|
| Kegel exercise education | No intervention | Prostate cancer patients of control group will received Kegel exercise education for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. |
| Extracorporeal biofeedback device | Experimental | Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. Receives: Device: Extracorporeal biofeedback device (Any Kegel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of urinary continence
weight of pad (g) by 24 hours pad test
Measured: postoperative 1 month
Secondary outcomes (2)
Recovery of urinary continence
weight of pad (g) by 24 hours pad test
Measured: postoperative 3 month
Recovery of urinary continence
number of pads for 24 hours
Measured: postoperative 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Furun Medical
- Responsible party
- Principal investigator, Seok-Soo Byun, Seoul National University Hospital
- Investigators
- Seok-Soo Byun, M.D.,Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485665
- Sponsor's protocol ID
- L-2015-298
- Status last verified
- Nov 2015
- First submitted
- 26 Jun 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oh JJ, Kim JK, Lee H, Lee S, Jin Jeong S, Kyu Hong S, Eun Lee S, Byun SS. Effect of personalized extracorporeal biofeedback device for pelvic floor muscle training on urinary incontinence after robot-assisted radical prostatectomy: A randomized controlled trial. Neurourol Urodyn. 2020 Feb;39(2):674-681. doi: 10.1002/nau.24247. Epub 2019 Dec 2.
PubMed 31793032
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personalized Extracorporeal Biofeedback Device for Pelvic Floor Muscle Training on Post-prostatectomy Incontinence
- ClinicalTrials.gov ID
- NCT02485665
- Acronym / sponsor ID
- L-2015-298
- Conditions
- Prostate Neoplasm, Prostatectomy, Surgical Procedures, Robotic, Urinary Incontinence, Biofeedback, Pelvic Floor
- Keywords
- Prostate cancer, Robot-assisted laparoscopic surgery, Radical prostatectomy, Post-prostatectomy incontinence, Pelvic floor muscle exercise, Extracorporeal biofeedback device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Furun Medical
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 30 Jun 2015 (estimated)
- 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.
To evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence
Detailed description
- Post prostatectomy urinary incontinence (PPI) was common complication after radical prostatectomy among prostate cancer patients.
- The prevalence of post-prostatectomy urinary incontinence was reported at 87%.
- The pelvic floor muscle therapy (PFMT) using Kegel exercise was first methods to prevent PPI after prostatectomy.
- However, there was no standardized protocol of the PFMT and it was necessary of biofeedback to PFMT.
- Therefore, we hypothesis the efficacy of personalized device of PFMT with biofeedback among patients who underwent radical prostatectomy
- In this study, we evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kegel exercise education | No intervention | –Prostate cancer patients of control group will received Kegel exercise education for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. |
| Extracorporeal biofeedback device | Experimental | Device: Extracorporeal biofeedback device (Any Kegel)Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prostate cancer patients who underwent robotic radical prostatectomy
- Neurovascular saving at least one side
- Bladder neck reconstruction at prostatectomy
- Posterior reconstruction at prostatectomy
- Patients who have post-prostatectomy incontinence after Foley catheter removal
Key exclusion criteria (6 listed)
- Patients who have not post-prostatectomy incontinence after Foley catheter removal
- Neurological deficits
- Anatomic deformities of pelvic bone
- Pelvic irradiation history
- History of other major urological procedures
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 |
|---|---|---|
| Extracorporeal biofeedback device (Any Kegel)Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. Enrolled patients in intervention group should be performed PFME regularly, based on following protocols: total exercise time (10 minutes/day), intensity (1.2 kgf), tension duration (10 sec/ 1 contraction), total exercise number (4 times/day) | Device | Extracorporeal biofeedback device |
Primary outcome
Recovery of urinary continence
Time frame: postoperative 1 month
weight of pad (g) by 24 hours pad test
2 secondary outcomes
Recovery of urinary continence
Time frame: postoperative 3 month
Recovery of urinary continence
Time frame: postoperative 1 and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Derived from this study: PubMed 31793032Oh JJ, Kim JK, Lee H, Lee S, Jin Jeong S, Kyu Hong S, Eun Lee S, Byun SS. Effect of personalized extracorporeal biofeedback device for pelvic floor muscle training on urinary incontinence after robot-assisted radical prostatectomy: A randomized controlled trial. Neurourol Urodyn. 2020 Feb;39(2):674-681. doi: 10.1002/nau.24247. Epub 2019 Dec 2.
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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.
Seok-Soo Byun, M.D.,Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal biofeedback device (Any Kegel) in people with Prostate Neoplasm and Prostatectomy, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Nov 2015. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minyong Kang, M.D.,Ph.D. (82-31-787-6631, dr.minyong.kang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of urinary continence (time frame: postoperative 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485665, which also lists 1 linked publication.
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 18 Nov 2015.