Prostate CancerNCT07333807
Efficacy of the Pelvic Clock® Device for Functional Recovery After Robotic-Assisted Radical Prostatectomy
A study testing Pelvic Clock® and Standard Pelvic Floor Muscle Training (PFMT) in people with Prostate Cancer and Radical Prostatectomy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This randomized controlled trial evaluates the efficacy of the Pelvic Clock® device, a proprioceptive neuromuscular facilitation tool, in accelerating functional recovery following Robotic-Assisted Radical Prostatectomy (RARP). Read more about this study
- Who is it for?
- Ages 55 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Radical Prostatectomy
- What is being tested?
- Pelvic Clock® and Standard Pelvic Floor Muscle Training (PFMT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2024to 28 Dec 2025
- 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 55 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with localized prostate cancer.
- Scheduled for Robotic-Assisted Radical Prostatectomy (RARP).
- Age between 55 and 80 years.
Who cannot join
- History of neurological disorders affecting pelvic floor function (e.g., -Parkinson's disease, multiple sclerosis, CVA).
- Adjuvant radiotherapy or androgen deprivation therapy.
- Salvage prostatectomy.
- Advanced tumor stage (cT4 or N+).
- Prior pelvic surgery or radiation.
- Cognitive impairment or physical inability to perform prescribed exercises .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Pelvic Clock® Device on Functional Recovery After Robotic-Assisted Radical Prostatectomy: A Randomized Controlled Trial
This randomized controlled trial evaluates the efficacy of the Pelvic Clock® device, a proprioceptive neuromuscular facilitation tool, in accelerating functional recovery following Robotic-Assisted Radical Prostatectomy (RARP). The study compares the device intervention against standard Pelvic Floor Muscle Training (PFMT) instructions. The primary goal is to assess the "Trifecta" achievement rate (cancer control, urinary continence, and potency) at 6 months post-surgery.
Read the detailed description
Functional recovery, specifically urinary continence and erectile potency, remains a major challenge following RARP. Standard PFMT is often limited by poor patient compliance and incorrect muscle isolation. The Pelvic Clock® device is designed to enhance proprioception and facilitate multi-directional control of pelvic floor muscles. Participants undergoing RARP were randomized 1:1 to either the intervention group (Pelvic Clock + Standard PFMT) or the control group (Standard PFMT alone). Functional outcomes, including incontinence (pad weight), erectile function (IIEF-5), and muscle strength (Oxford scale), were assessed at baseline, 1, 3, and 6 months postoperatively.
- Conditions
- Prostate Cancer, Radical Prostatectomy
- Being tested
- Pelvic Clock®, Standard Pelvic Floor Muscle Training (PFMT)
- Keywords
- prostate cancer, Robotic-assisted radical prostatectomy, Pelvic Clock
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Clock®Device
Participants used the device for neuromuscular re-education. Protocol:
Frequency: 2 sessions per day.
Duration: 5-10 minutes per session.
Schedule: Minimum 5 days/week.
Repetitions: 10-20 repetitions for specific movements (e.g., 12-6 o'clock tilt, 3-9 o'clock tilt). Participants also adhered to the standard PFMT regimen (3-4 sets/day) .
Standard Pelvic Floor Muscle Training (PFMT)Behavioural
Standard Kegel exercises without assistive devices.
Frequency: 3-4 sets per day.
Intensity: Sustain each contraction for 5-10 seconds, followed by 5-10 seconds relaxation.
Repetitions: 10-15 repetitions per set
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Pelvic Clock Group | Experimental | Participants performed specific exercises using the Pelvic Clock® device in addition to the standard PFMT regimen. Receives: Device: Pelvic Clock® |
| Active Comparator: Control Group | Active comparator | Participants received standard of care with verbal and written instructions for Pelvic Floor Muscle Training (PFMT). Receives: Behavioral: Standard Pelvic Floor Muscle Training (PFMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trifecta Achievement Rate
Composite outcome defined as the simultaneous fulfillment of: (1) Cancer control (PSA < 0.2 ng/mL); (2) Urinary continence (0 pads/day); and (3) Potency (ability to achieve erection sufficient for intercourse)
Measured: 6 months post-surgery
Secondary outcomes (5)
Erectile Function (IIEF-5 Score)
Assessed using the International Index of Erectile Function-5. Scores range from 5 to 25, with higher scores indicating better erectile function.
Measured: Baseline, 1, 3, and 6 months post-surgery
Urinary Incontinence (24-hour Pad Weight)
Objective quantification of urinary leakage measured in grams.
Measured: Baseline, 1, 3, and 6 months post-surgery
Pelvic Floor Muscle Strength (Modified Oxford Scale)
Assessed via Digital Rectal Examination (DRE). Scores range from 0 (no contraction) to 5 (strong contraction).
Measured: Baseline, 1, 3, and 6 months post-surgery
Urinary Quality of Life (EPIC-Urinary Domain)
Expanded Prostate Cancer Index Composite - Urinary Domain. Scores range 0-100, higher scores indicate better QoL.
Measured: Baseline, 1, 3, and 6 months post-surgery
Postoperative Pain (VAS)
Visual Analog Scale. Scores range 0-10, lower scores indicate less pain.
Measured: Baseline, 1, 3, and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Oct 2024
- Primary completion31 Aug 2025
- Study completion28 Dec 2025
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MING-HSIN, YANG, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333807
- Sponsor's protocol ID
- TSGH-B2025051PC
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Pelvic Clock® Device on Functional Recovery After Robotic-Assisted Radical Prostatectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07333807
- Acronym / sponsor ID
- TSGH-B2025051PC
- Conditions
- Prostate Cancer, Radical Prostatectomy
- Keywords
- prostate cancer, Robotic-assisted radical prostatectomy, Pelvic Clock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 12 Jan 2026 (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 randomized controlled trial evaluates the efficacy of the Pelvic Clock® device, a proprioceptive neuromuscular facilitation tool, in accelerating functional recovery following Robotic-Assisted Radical Prostatectomy (RARP). The study compares the device intervention against standard Pelvic Floor Muscle Training (PFMT) instructions. The primary goal is to assess the "Trifecta" achievement rate (cancer control, urinary continence, and potency) at 6 months post-surgery.
Detailed description
Functional recovery, specifically urinary continence and erectile potency, remains a major challenge following RARP. Standard PFMT is often limited by poor patient compliance and incorrect muscle isolation. The Pelvic Clock® device is designed to enhance proprioception and facilitate multi-directional control of pelvic floor muscles. Participants undergoing RARP were randomized 1:1 to either the intervention group (Pelvic Clock + Standard PFMT) or the control group (Standard PFMT alone). Functional outcomes, including incontinence (pad weight), erectile function (IIEF-5), and muscle strength (Oxford scale), were assessed at baseline, 1, 3, and 6 months postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Pelvic Clock Group | Experimental | Device: Pelvic Clock®Participants performed specific exercises using the Pelvic Clock® device in addition to the standard PFMT regimen. |
| Active Comparator: Control Group | Active comparator | Behavioral: Standard Pelvic Floor Muscle Training (PFMT)Participants received standard of care with verbal and written instructions for Pelvic Floor Muscle Training (PFMT). |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with localized prostate cancer.
- Scheduled for Robotic-Assisted Radical Prostatectomy (RARP).
- Age between 55 and 80 years.
Key exclusion criteria (6 listed)
- History of neurological disorders affecting pelvic floor function (e.g., -Parkinson's disease, multiple sclerosis, CVA).
- Adjuvant radiotherapy or androgen deprivation therapy.
- Salvage prostatectomy.
- Advanced tumor stage (cT4 or N+).
- Prior pelvic surgery or radiation.
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 |
|---|---|---|
| Pelvic Clock®Participants used the device for neuromuscular re-education. Protocol: Frequency: 2 sessions per day. Duration: 5-10 minutes per session. Schedule: Minimum 5 days/week. Repetitions: 10-20 repetitions for specific movements (e.g., 12-6 o'clock tilt, 3-9 o'clock tilt). Participants also adhered to the standard PFMT regimen (3-4 sets/day) . | Device | Experimental: Pelvic Clock Group |
| Standard Pelvic Floor Muscle Training (PFMT)Standard Kegel exercises without assistive devices. Frequency: 3-4 sets per day. Intensity: Sustain each contraction for 5-10 seconds, followed by 5-10 seconds relaxation. Repetitions: 10-15 repetitions per set | Behavioural | Active Comparator: Control Group |
Primary outcome
Trifecta Achievement Rate
Time frame: 6 months post-surgery
Composite outcome defined as the simultaneous fulfillment of: (1) Cancer control (PSA < 0.2 ng/mL); (2) Urinary continence (0 pads/day); and (3) Potency (ability to achieve erection sufficient for intercourse)
5 secondary outcomes
Erectile Function (IIEF-5 Score)
Time frame: Baseline, 1, 3, and 6 months post-surgery
Urinary Incontinence (24-hour Pad Weight)
Time frame: Baseline, 1, 3, and 6 months post-surgery
Pelvic Floor Muscle Strength (Modified Oxford Scale)
Time frame: Baseline, 1, 3, and 6 months post-surgery
Urinary Quality of Life (EPIC-Urinary Domain)
Time frame: Baseline, 1, 3, and 6 months post-surgery
Postoperative Pain (VAS)
Time frame: Baseline, 1, 3, and 6 months post-surgery
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 12 Jan 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Pelvic Clock® and Standard Pelvic Floor Muscle Training (PFMT) in people with Prostate Cancer and Radical Prostatectomy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 12 Jan 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 Taiwan. 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?
Trifecta Achievement Rate (time frame: 6 months post-surgery). 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 12 Jan 2026.