Urinary Incontinence , StressNCT06589869
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
A study testing EM Chair in people with Urinary Incontinence , Stress and Prostatectomy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 months and older, men only
- Conditions the study is for
- Urinary Incontinence , Stress, Prostatectomy
- What is being tested?
- EM Chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Jul 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 months and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergone robotic radical prostatectomy
- Able to carry out 1-hour pad test
- Voluntary participation and signing of the informed consent form
Who cannot join
- Pre-existing stress urinary incontinence
- Post-void residual urine greater than 200ml
- Active urinary tract infection
- Urethral or bladder fistula
- History of pelvic irradiation
- Neurological condition (Spinal cord problems, stroke with poor neurological recovery, epilepsy, Parkinson disease, multiple sclerosis)
Show all 9Show fewer
- Previous surgery for SUI
- Concurrent medication with diuretics, serotonin-norepinephrine reuptake inhibitors or any other medication known to worsen incontinence
- Condition contraindicated for electromagnetic therapy i.e. Arrhythmia, on a pacemaker or implanted metallic device; Coagulopathy or on anticoagulant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Chi Fai NG, MD, 3505 2625, ngcf@surgery.cuhk.edu.hk
About this study
Official title: To Investigate the Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of Stress Urinary Incontinence Compared With Standard of Care in Chinese Men Who Had Undergone Robotic Radical Prostatectomy
This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy.
Read the detailed description
This is a prospective randomised control trial of consecutive patients with prostatectomy to have either standard of care versus HIFEM assisted pelvic floor exercise. Randomization will be performed for patients when the subject has completed the informed consent for study participation. Randomization will be performed in 1:1 ratio into 2 arms: HIFEM assisted (BTL EMsella) pelvic floor muscle training (Arm A) plus Standard of care or Standard of care (Arm B).
- Conditions
- Urinary Incontinence , Stress, Prostatectomy
- Being tested
- EM Chair, Standard of care
- Keywords
- stress urinary incontinence, prostatectomy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EM ChairDevice
Patients who randomised to intervention group (Arm A) will receive HIFEM assisted (BTL EMsella) pelvic floor muscle training for total 6 sessions (2 session per week, 30 minutes per session with modulated intensity) plus standard of care. The intervention will be started within 2 weeks after Foley Catheter removed. Patients will attend follow up for training and at 1, 3 and 6 month post-operatively.
Standard of careOther
Standard of care. Perioperative education for information related to prostatectomy and pelvic floor exercise training. Patient were advice to perform pelvic floor exercise at least 30 times per day
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care. Perioperative education for information related to prostatectomy and pelvic floor exercise training. Patient were advice to perform pelvic floor exercise at least 30 times per day Receives: Other: Standard of care |
| EM Chair | Experimental | Patients who randomised to intervention group (Arm A) will receive HIFEM assisted (BTL EMsella) pelvic floor muscle training for total 6 sessions (2 session per week, 30 minutes per session with modulated intensity) plus standard of care. The intervention will be started within 2 weeks after Foley Catheter removed. Patients will attend follow up for training and at 1, 3 and 6 month post-operatively. Receives: Device: EM Chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight of 1-hour pad test
Weight of 1-hour pad test
Measured: Baseline, Month 1, Month 3 and Month 6
Secondary outcomes (4)
Severity of Incontinence.
It is evaluated by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short FormInternational Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The ICIQ score with a range from 0-21; the higher the score the worse of incontinence
Measured: Baseline, Month 1, Month 3 and Month 6
Sexual Function
It is evaluated by International Index of Erectile Function Score (IIEF-5). The IIEF-5 score is the sum of the ordinal response to the 5 items. The lowest the score, the more severe of erectile dysfunction
Measured: Baseline, Month 1, Month 3 and Month 6
Severity of Incontinence
The number of pads used
Measured: Baseline, Month 1, Month 3 and Month 6
Complications
It is evaluated by CTCAE Grade 5
Measured: Month 1, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start29 Jul 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence , StressStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Chi Fai, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589869
- Sponsor's protocol ID
- CRE-2021.506-T
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anderson CA, Omar MI, Campbell SE, Hunter KF, Cody JD, Glazener CM. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2015 Jan 20;1(1):CD001843. doi: 10.1002/14651858.CD001843.pub5.
PubMed 25602133Kashanian M, Ali SS, Nazemi M, Bahasadri S. Evaluation of the effect of pelvic floor muscle training (PFMT or Kegel exercise) and assisted pelvic floor muscle training (APFMT) by a resistance device (Kegelmaster device) on the urinary incontinence in women: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):218-23. doi: 10.1016/j.ejogrb.2011.06.037. Epub 2011 Jul 7.
PubMed 21741151Fernandez RA, Garcia-Hermoso A, Solera-Martinez M, Correa MT, Morales AF, Martinez-Vizcaino V. Improvement of continence rate with pelvic floor muscle training post-prostatectomy: a meta-analysis of randomized controlled trials. Urol Int. 2015;94(2):125-32. doi: 10.1159/000368618.
PubMed 25427689Samuels JB, Pezzella A, Berenholz J, Alinsod R. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers Surg Med. 2019 Nov;51(9):760-766. doi: 10.1002/lsm.23106. Epub 2019 Jun 7.
PubMed 31172580Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
PubMed 18354103Wang W, Huang QM, Liu FP, Mao QQ. Effectiveness of preoperative pelvic floor muscle training for urinary incontinence after radical prostatectomy: a meta-analysis. BMC Urol. 2014 Dec 16;14:99. doi: 10.1186/1471-2490-14-99.
PubMed 25515968Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, Gingrich JR, Wei JT, Gilhooly P, Grob BM, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Sharifi R, Blank W, Pandya P, Andriole GL, Culkin D, Wheeler T; Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162.
PubMed 22808955
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of Stress Urinary Incontinence Compared With Standard of Care in Chinese Men Who Had Undergone Robotic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06589869
- Acronym / sponsor ID
- CRE-2021.506-T
- Conditions
- Urinary Incontinence , Stress, Prostatectomy
- Keywords
- stress urinary incontinence, prostatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 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.
This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy.
Detailed description
This is a prospective randomised control trial of consecutive patients with prostatectomy to have either standard of care versus HIFEM assisted pelvic floor exercise. Randomization will be performed for patients when the subject has completed the informed consent for study participation. Randomization will be performed in 1:1 ratio into 2 arms: HIFEM assisted (BTL EMsella) pelvic floor muscle training (Arm A) plus Standard of care or Standard of care (Arm B).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of careStandard of care. Perioperative education for information related to prostatectomy and pelvic floor exercise training. Patient were advice to perform pelvic floor exercise at least 30 times per day |
| EM Chair | Experimental | Device: EM ChairPatients who randomised to intervention group (Arm A) will receive HIFEM assisted (BTL EMsella) pelvic floor muscle training for total 6 sessions (2 session per week, 30 minutes per session with modulated intensity) plus standard of care. The intervention will be started within 2 weeks after Foley Catheter removed. Patients will attend follow up for training and at 1, 3 and 6 month post-operatively. |
Who may qualify
- Ages
- 18 months and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Undergone robotic radical prostatectomy
- Able to carry out 1-hour pad test
- Voluntary participation and signing of the informed consent form
Key exclusion criteria (9 listed)
- Pre-existing stress urinary incontinence
- Post-void residual urine greater than 200ml
- Active urinary tract infection
- Urethral or bladder fistula
- History of pelvic irradiation
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 |
|---|---|---|
| EM ChairPatients who randomised to intervention group (Arm A) will receive HIFEM assisted (BTL EMsella) pelvic floor muscle training for total 6 sessions (2 session per week, 30 minutes per session with modulated intensity) plus standard of care. The intervention will be started within 2 weeks after Foley Catheter removed. Patients will attend follow up for training and at 1, 3 and 6 month post-operatively. | Device | EM Chair |
| Standard of careStandard of care. Perioperative education for information related to prostatectomy and pelvic floor exercise training. Patient were advice to perform pelvic floor exercise at least 30 times per day | Other | Standard of Care |
Primary outcome
Weight of 1-hour pad test
Time frame: Baseline, Month 1, Month 3 and Month 6
Weight of 1-hour pad test
4 secondary outcomes
Severity of Incontinence.
Time frame: Baseline, Month 1, Month 3 and Month 6
Sexual Function
Time frame: Baseline, Month 1, Month 3 and Month 6
Severity of Incontinence
Time frame: Baseline, Month 1, Month 3 and Month 6
Complications
Time frame: Month 1, Month 3 and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 25602133Anderson CA, Omar MI, Campbell SE, Hunter KF, Cody JD, Glazener CM. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2015 Jan 20;1(1):CD001843. doi: 10.1002/14651858.CD001843.pub5.
- Background: PubMed 21741151Kashanian M, Ali SS, Nazemi M, Bahasadri S. Evaluation of the effect of pelvic floor muscle training (PFMT or Kegel exercise) and assisted pelvic floor muscle training (APFMT) by a resistance device (Kegelmaster device) on the urinary incontinence in women: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):218-23. doi: 10.1016/j.ejogrb.2011.06.037. Epub 2011 Jul 7.
- Background: PubMed 25427689Fernandez RA, Garcia-Hermoso A, Solera-Martinez M, Correa MT, Morales AF, Martinez-Vizcaino V. Improvement of continence rate with pelvic floor muscle training post-prostatectomy: a meta-analysis of randomized controlled trials. Urol Int. 2015;94(2):125-32. doi: 10.1159/000368618.
- Background: PubMed 31172580Samuels JB, Pezzella A, Berenholz J, Alinsod R. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers Surg Med. 2019 Nov;51(9):760-766. doi: 10.1002/lsm.23106. Epub 2019 Jun 7.
- Background: PubMed 18354103Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
- Background: PubMed 25515968Wang W, Huang QM, Liu FP, Mao QQ. Effectiveness of preoperative pelvic floor muscle training for urinary incontinence after radical prostatectomy: a meta-analysis. BMC Urol. 2014 Dec 16;14:99. doi: 10.1186/1471-2490-14-99.
- Background: PubMed 22808955Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, Gingrich JR, Wei JT, Gilhooly P, Grob BM, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Sharifi R, Blank W, Pandya P, Andriole GL, Culkin D, Wheeler T; Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162.
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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.
Chi Fai NG, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EM Chair in people with Urinary Incontinence , Stress and Prostatectomy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Fai NG, MD (35052625, ngcf@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight of 1-hour pad test (time frame: Baseline, Month 1, Month 3 and Month 6). 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 NCT06589869, which also lists 7 linked publications.
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 22 Oct 2026.