Benign Prostatic HyperplasiaNCT06742489
Research for the Efficacy and Safety of Percutaneous Tibial Nerve Stimulation to Promote Storage Symptoms Postoperative Recovery for Patients With Benign Prostatic Hyperplasia
A study testing Percutaneous tibial nerve stimulation device in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Zhu Yiping.
Trial summary
The goal of this clinical trial is to guide and promote the clinical application of T-PTNS in promoting the postoperative recovery of urinary storage symptoms in patients with BPH. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Percutaneous tibial nerve stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants have been fully informed of the potential benefits and risks associated with the trial and have provided written consent to participate.
- Male participants between the ages of 45 and 80 are eligible to participate in the trial.
- Participants with a confirmed diagnosis of Benign Prostatic Hyperplasia, a maximum urinary flow rate of ≤ 15 ml/sec, undergoing surgical treatment (Thulium laser vapoenucleation) and fulfilling any one of the following conditions according to the International Prostate Symptom Score (IPSS): a) any single IPSS urinary storage subscore (urinary frequency, urgency, nocturia frequency) greater than or equal to 3 points; b) a total IPSS storage subscore of 9 points or greater;
- Participants who are able to discontinue relevant medications (M-blockers and β3 agonists) for a period of at least one week prior to enrolment;
- Participants with autonomy, self-care, self-control, and the ability to use the toilet independently.
Who cannot join
- Subjects presenting with urinary incontinence due to reduced sphincter function, or subjects evaluated for neurogenic bladder;
- Subjects with urethral strictures or bladder neck contractures that make insertion of devices difficult;
- Subjects with pacemakers, buried cardioverter-defibrillators, or other therapeutic electronic medical devices (including sacral neuromodulation).
- Subjects with implanted devices in the body;
- Subjects with untreated urinary tract infections;
- Subjects with urinary stones that cause lower urinary tract symptoms;
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- Subjects with previous pelvic surgery; and
- Subjects with a history of previous pelvic surgery, or colorectal surgery (except polypectomy and haemorrhoidectomy);
- Subjects with untreated malignant tumors;
- Subjects with neurological or cerebrovascular lesions or injuries, or medical conditions affecting cognition, bladder function, sphincter function, or urethral muscle function;
- Subjects with skin breakdown, malignant tumors, or acute purulent inflammation on the surface of the plantar foot at the location where the electrode pads are to be placed;11. Subjects who have participated in a clinical trial of another drug within three months or a clinical trial of another medical device within 30 days;
- Other conditions that the investigator deems unsuitable for participation in the study.
About this study
Official title: Research for the Efficacy and Safety of Percutaneous Tibial Nerve Stimulation to Promote Storage Symptoms Postoperative Recovery for Patients With Benign Prostatic Hyperplasia(Randomised, Double-blind, Prospective, Single-centre Clinical Trial)
The goal of this clinical trial is to guide and promote the clinical application of T-PTNS in promoting the postoperative recovery of urinary storage symptoms in patients with BPH. The main question is to evaluate the effectiveness and safety of T-PTNS in promoting the improvement of postoperative urinary storage symptoms in patients with BPH through a single-center randomized double-blind controlled trial, and to propose standard parameters for use such as frequency and power, and ultimately to establish a standard process of T-PTNS treatment and form a replicable and promotable therapeutic specification. Participants will receive T-PTNS three times a week for 30 minutes every time. T-PTNS will be discontinued after 6 weeks. The study will last for 12 weeks, and subjects will be followed up periodically during the study period by the relevant researchers.
- Being tested
- Percutaneous tibial nerve stimulation device, Sham group device
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous tibial nerve stimulation deviceDevice
T-PTNS primarily delivers electrical stimulation to the sacral voiding center via the tibial nerve through the S2-S4 sacral plexus via skin-surface electrodes to improve patients' symptoms of urinary frequency, urgency, and urge incontinence.
Sham group deviceDevice
The device in the sham group is manufactured by the same company and has the same appearance, display interface, and operation method as the device in the treatment group. These devices have the output circuit disconnected and no actual current output.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants in this group will receive T-PTNS three times a week for 30 minutes every time. Receives: Device: Percutaneous tibial nerve stimulation device |
| Sham group | Sham comparator | The sham group will use the same device without therapeutic effect as a blank control. Receives: Device: Sham group device |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptoms Score improvement percentage
The study will use International Prostate Symptoms Score (IPSS) questionnaire to evaluate the effectiveness of the treatment. IPSS improvement percentage is defined as dividing the difference between preoperative and postoperative IPSS by preoperative IPSS, which varies from 0% to 100%. If the score is over 50%, the treatment will be considered as effective.
Measured: 2,4,6,8,12 weeks after surgery
Quality of Life change
The study will use International Prostate Symptoms Score (IPSS) questionnaire to evaluate the effectiveness of the treatment. Quality of Life (QoL) is the last question of the questionnaire. QoL change is defined as the difference between preoperative and postoperative QoL, which varies from 0 to 6. If the score is over 3, the treatment will be considered as effective.
Measured: 2,4,6,8,12 weeks after surgery
Secondary outcomes (2)
maximum urinary flow change
The study will use free uroflow to assess objective change, with maximum urinary flow (Qmax) as the primary outcome measure. Qmax change is defined as the difference between preoperative and postoperative Qmax. The score is not capped, but the higher the score, the better the outcome.
Measured: 6,12 weeks after surgery
Overactive Bladder Symptom Score change percentage
The study will use Overactive Bladder Symptom Score (OABSS) questionnaire to evaluate the effectiveness of the treatment. OABSS change percentage is defined as dividing the difference between preoperative and postoperative OABSS by preoperative OABSS, which varies from 0 to 15. If the score is over 50%, the treatment will be considered as effective.
Measured: 2,4,6,8,12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial will include patients with storage symptoms as the main manifestation and undergo surgical treatment for benign prostatic hyperplasia. There is still a lack of similar products on the market to be used as a control, and thus the sham group will use the same device without therapeutic effect as a blank control.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Yiping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Yiping, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742489
- Sponsor's protocol ID
- 2024218
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for the Efficacy and Safety of Percutaneous Tibial Nerve Stimulation to Promote Storage Symptoms Postoperative Recovery for Patients With Benign Prostatic Hyperplasia(Randomised, Double-blind, Prospective, Single-centre Clinical Trial)
- ClinicalTrials.gov ID
- NCT06742489
- Acronym / sponsor ID
- 2024218
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zhu YipingUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 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 goal of this clinical trial is to guide and promote the clinical application of T-PTNS in promoting the postoperative recovery of urinary storage symptoms in patients with BPH. The main question is to evaluate the effectiveness and safety of T-PTNS in promoting the improvement of postoperative urinary storage symptoms in patients with BPH through a single-center randomized double-blind controlled trial, and to propose standard parameters for use such as frequency and power, and ultimately to establish a standard process of T-PTNS treatment and form a replicable and promotable therapeutic specification. Participants will receive T-PTNS three times a week for 30 minutes every time. T-PTNS will be discontinued after 6 weeks. The study will last for 12 weeks, and subjects will be followed up periodically during the study period by the relevant researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This trial will include patients with storage symptoms as the main manifestation and undergo surgical treatment for benign prostatic hyperplasia. There is still a lack of similar products on the market to be used as a control, and thus the sham group will use the same device without therapeutic effect as a blank control.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Percutaneous tibial nerve stimulation deviceParticipants in this group will receive T-PTNS three times a week for 30 minutes every time. |
| Sham group | Sham comparator | Device: Sham group deviceThe sham group will use the same device without therapeutic effect as a blank control. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants have been fully informed of the potential benefits and risks associated with the trial and have provided written consent to participate.
- Male participants between the ages of 45 and 80 are eligible to participate in the trial.
- Participants with a confirmed diagnosis of Benign Prostatic Hyperplasia, a maximum urinary flow rate of ≤ 15 ml/sec, undergoing surgical treatment (Thulium laser vapoenucleation) and fulfilling any one of the following conditions according to the International Prostate Symptom Score (IPSS): a) any single IPSS urinary storage subscore (urinary frequency, urgency, nocturia frequency) greater than or equal to 3 points; b) a total IPSS storage subscore of 9 points or greater;
- Participants who are able to discontinue relevant medications (M-blockers and β3 agonists) for a period of at least one week prior to enrolment;
- Participants with autonomy, self-care, self-control, and the ability to use the toilet independently.
Key exclusion criteria (12 listed)
- Subjects presenting with urinary incontinence due to reduced sphincter function, or subjects evaluated for neurogenic bladder;
- Subjects with urethral strictures or bladder neck contractures that make insertion of devices difficult;
- Subjects with pacemakers, buried cardioverter-defibrillators, or other therapeutic electronic medical devices (including sacral neuromodulation).
- Subjects with implanted devices in the body;
- Subjects with untreated urinary tract infections;
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 |
|---|---|---|
| Percutaneous tibial nerve stimulation deviceT-PTNS primarily delivers electrical stimulation to the sacral voiding center via the tibial nerve through the S2-S4 sacral plexus via skin-surface electrodes to improve patients' symptoms of urinary frequency, urgency, and urge incontinence. | Device | Treatment group |
| Sham group deviceThe device in the sham group is manufactured by the same company and has the same appearance, display interface, and operation method as the device in the treatment group. These devices have the output circuit disconnected and no actual current output. | Device | Sham group |
Primary outcome
International Prostate Symptoms Score improvement percentage
Time frame: 2,4,6,8,12 weeks after surgery
The study will use International Prostate Symptoms Score (IPSS) questionnaire to evaluate the effectiveness of the treatment. IPSS improvement percentage is defined as dividing the difference between preoperative and postoperative IPSS by preoperative IPSS, which varies from 0% to 100%. If the score is over 50%, the treatment will be considered as effective.
Quality of Life change
Time frame: 2,4,6,8,12 weeks after surgery
The study will use International Prostate Symptoms Score (IPSS) questionnaire to evaluate the effectiveness of the treatment. Quality of Life (QoL) is the last question of the questionnaire. QoL change is defined as the difference between preoperative and postoperative QoL, which varies from 0 to 6. If the score is over 3, the treatment will be considered as effective.
2 secondary outcomes
maximum urinary flow change
Time frame: 6,12 weeks after surgery
Overactive Bladder Symptom Score change percentage
Time frame: 2,4,6,8,12 weeks after surgery
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 19 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous tibial nerve stimulation device in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Zhu Yiping.
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 12 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: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
International Prostate Symptoms Score improvement percentage (time frame: 2,4,6,8,12 weeks after surgery). The study lists 2 primary outcomes in all. 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 19 Dec 2024.