Prostate Cancer (Post Prostatectomy)NCT06740071
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
A study testing somatosensory interactive pelvic floor muscle training, pelvic floor magnetic stimulation therapy and standard pelvic floor muscle training in people with Prostate Cancer (Post Prostatectomy), run by The University of Hong Kong at 2 sites in 2 countries.
Trial summary
The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer (Post Prostatectomy)
- What is being tested?
- somatosensory interactive pelvic floor muscle training, pelvic floor magnetic stimulation therapy and standard pelvic floor muscle training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2023to Apr 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)
Who cannot join
- patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Nurse Consultant, BNurs, 86-021-34186000, xy20848@rjh.com.cn
Nurse Consultant, BNurs
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, Hong Kong
Research Assistant, 852-22554852, stac@hku.hk
Yung NA, BM, MD, MPH
About this study
The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). The methods being compared include standard PFMT (S-PFMT) , a somatosensory interactive PFMT (SI-PFMT, an enhanced PFMT) , and a standard PFMT combined with pelvic floor muscle magnetic stimulation (S-PFMT+MS). Eligible participants are randomized into either of the groups to receive different modalities of post-operative PFMT.
Subjects in the S-PFMT group received traditional verbal instructions and paper-based educational materials. For the SI-PFMT group, an interactive experiential education model was adopted. First, an educational video introduced the importance and basic information of postoperative PFMT. Then, synchronized PFMT guidance through a combination of audio and video would be used. Subjects assigned to the S-PFMT+MS group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician.
Self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Being tested
- somatosensory interactive pelvic floor muscle training, pelvic floor magnetic stimulation therapy, standard pelvic floor muscle training
- Keywords
- pelvic floor muscle training, post operative urinary incontinence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatosensory interactive pelvic floor muscle trainingBehavioural
synchronized PFMT guidance through a combination of audio and video
pelvic floor magnetic stimulation therapyProcedure or surgery
stimulation frequency was set at 10 Hz, with stimulation administered in cycles of 5 seconds on followed by 5 seconds off. Each treatment session lasted 20 minutes, conducted twice a week, for a total of 10-12 sessions
standard pelvic floor muscle trainingBehavioural
traditional verbal instructions and paper-based educational materials of PFMT are given to participants.
All patients would receive PFMT under the guidance of digital rectal examination by nurses, and their pelvic floor muscle function was graded according to the Oxford Grading System (grades 0-5), ensuring the correctness of subsequent PFMT.
| Study group | Role | What they receive |
|---|---|---|
| standard pelvic floor muscle training group | Active comparator | Not described Receives: Behavioral: standard pelvic floor muscle training |
| somatosensory interactive pelvic floor muscle training group | Active comparator | Not described Receives: Behavioral: somatosensory interactive pelvic floor muscle training |
| standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group | Experimental | Not described Receives: Behavioral: somatosensory interactive pelvic floor muscle training; Procedure: pelvic floor magnetic stimulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
A higher score indicates a more severe urinary incontinence and thus a worse outcome. Reduction in score is expected for subjects with clinical improvement.
Range of score: 0 - 21 Severity of urinary incontinence: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)
Measured: 1, 3, and 6 months postoperatively.
Secondary outcomes (1)
urine leakage volume from the 1-hour pad test
Measured: 1, 3, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 May 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Post Prostatectomy)Studies of the same condition, open and under way.
- More trials run by The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Principal investigator, Yung NA, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740071
- Sponsor's protocol ID
- PFMT-RARP
- Status last verified
- Apr 2025
- First submitted
- 13 Dec 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Arrangement not approved by national law of institute.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06740071
- Acronym / sponsor ID
- PFMT-RARP
- Conditions
- Prostate Cancer (Post Prostatectomy)
- Keywords
- pelvic floor muscle training, post operative urinary incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Dec 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.
The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). The methods being compared include standard PFMT (S-PFMT) , a somatosensory interactive PFMT (SI-PFMT, an enhanced PFMT) , and a standard PFMT combined with pelvic floor muscle magnetic stimulation (S-PFMT+MS). Eligible participants are randomized into either of the groups to receive different modalities of post-operative PFMT.
Subjects in the S-PFMT group received traditional verbal instructions and paper-based educational materials. For the SI-PFMT group, an interactive experiential education model was adopted. First, an educational video introduced the importance and basic information of postoperative PFMT. Then, synchronized PFMT guidance through a combination of audio and video would be used. Subjects assigned to the S-PFMT+MS group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician.
Self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard pelvic floor muscle training group | Active comparator | Behavioral: standard pelvic floor muscle training |
| somatosensory interactive pelvic floor muscle training group | Active comparator | Behavioral: somatosensory interactive pelvic floor muscle training |
| standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group | Experimental | Behavioral: somatosensory interactive pelvic floor muscle training, Procedure: pelvic floor magnetic stimulation therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)
Key exclusion criteria (1 listed)
- patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors
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 |
|---|---|---|
| somatosensory interactive pelvic floor muscle trainingsynchronized PFMT guidance through a combination of audio and video | Behavioural | somatosensory interactive pelvic floor muscle training group, standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group |
| pelvic floor magnetic stimulation therapystimulation frequency was set at 10 Hz, with stimulation administered in cycles of 5 seconds on followed by 5 seconds off. Each treatment session lasted 20 minutes, conducted twice a week, for a total of 10-12 sessions | Procedure or surgery | standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group |
| standard pelvic floor muscle trainingtraditional verbal instructions and paper-based educational materials of PFMT are given to participants. All patients would receive PFMT under the guidance of digital rectal examination by nurses, and their pelvic floor muscle function was graded according to the Oxford Grading System (grades 0-5), ensuring the correctness of subsequent PFMT. | Behavioural | standard pelvic floor muscle training group |
Primary outcome
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: 1, 3, and 6 months postoperatively.
A higher score indicates a more severe urinary incontinence and thus a worse outcome. Reduction in score is expected for subjects with clinical improvement. Range of score: 0 - 21 Severity of urinary incontinence: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)
1 secondary outcome
urine leakage volume from the 1-hour pad test
Time frame: 1, 3, and 6 months postoperatively
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 4 Apr 2025.
- Individual participant dataSharing planned: No. Arrangement not approved by national law of institute.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing somatosensory interactive pelvic floor muscle training, pelvic floor magnetic stimulation therapy and standard pelvic floor muscle training in people with Prostate Cancer (Post Prostatectomy), run by The University of Hong Kong at 2 sites in 2 countries.
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 1 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, 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 Research Assistant, BSc (852-22554852, stac@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) (time frame: 1, 3, and 6 months postoperatively.). 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 4 Apr 2025.