Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia SurgeryPhase 3NCT06558539
Tibial Nerve Stimulation for Post-BPH Overactive Bladder
A Phase 3 study testing Transcutaneous Tibial Nerve Stimulation(TTNS), Combination Therapy and Standard Medication Therapy in people with Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery, run by Qing Yuan.
Trial summary
A single-center, randomized, parallel-controlled design. Approximately 90 cases of persistent overactive bladder symptoms post benign prostatic hyperplasia surgery are expected to be enrolled. The study participants will be randomly assigned to three groups, with 30 participants in each group. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
- What is being tested?
- Transcutaneous Tibial Nerve Stimulation(TTNS), Combination Therapy and Standard Medication Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Feb 2025
- Phase
- Phase 3
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with overactive bladder before benign prostatic hyperplasia 2.Overactive bladder still exists 1 month after the operation of benign prostatic hyperplasia; 3.50 ≤ age ≤80 , male 4.72-hour urination diary showed an average of ≥8 urination times every 24 hours at baseline
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Efficacy of Wearable Transcutaneous Tibial Nerve Stimulation for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
A single-center, randomized, parallel-controlled design. Approximately 90 cases of persistent overactive bladder symptoms post benign prostatic hyperplasia surgery are expected to be enrolled. The study participants will be randomly assigned to three groups, with 30 participants in each group.
- Being tested
- Transcutaneous Tibial Nerve Stimulation(TTNS), Combination Therapy, Standard Medication Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Tibial Nerve Stimulation(TTNS)Device
Participants in this group will discontinue all relevant medications (e.g., β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs) at least 14 days before signing the informed consent and will not use these medications during the study period. They will receive treatment solely with wearable transcutaneous tibial nerve stimulation.
Combination TherapyCombination product
Participants in this group will continue their prescribed medication regimen, which may include β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs, with dosages and administration unchanged throughout the study. In addition to the standard medication therapy, participants will receive wearable transcutaneous tibial nerve stimulation using a wearable device
Standard Medication TherapyDrug
Participants in this group will maintain their usual medication regimen, which may include β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs, with dosages and administration remaining consistent throughout the study. No additional interventions will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | Approximately 30 participants are expected to be enrolled, and they will receive a combination of standard medication and TTNS therapy for 12 weeks. Receives: Combination Product: Combination Therapy |
| TTNS | Experimental | Approximately 30 participants are expected to be enrolled, and they will receive TTNS therapy for 12 weeks. Receives: Device: Transcutaneous Tibial Nerve Stimulation(TTNS) |
| Standard Medication Therapy | Active comparator | Approximately 30 participants are expected to be enrolled, and they will receive standard medication and TTNS therapy for 12 weeks. Receives: Drug: Standard Medication Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Urination Frequency Compared to Baseline
At the end of Weeks 4, 8, and 12, the change in average daily urination frequency compared to baseline will be calculated using the participants' 72-hour voiding diaries
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Secondary outcomes (10)
Average Urinary Urgency Score
At the end of Weeks 4, 8, and 12, the average urinary urgency score will be calculated using the participants' 72-hour voiding diaries
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Average Daily Nocturia Frequency Compared to Baseline
At the end of Weeks 4, 8, and 12, the change in average daily nocturia frequency compared to baseline will be calculated using the participants' 72-hour voiding diaries
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Average Voided Volume per Urination Compared to Baseline
At the end of Weeks 4, 8, and 12, the change in average voided volume per urination compared to baseline will be calculated using the participants' 72-hour voiding diaries
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Average Daily Incontinence Episodes
At the end of Weeks 4, 8, and 12, the average daily incontinence episodes will be calculated using the participants' 72-hour voiding diaries
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
OABSS Compared to Baseline
At the end of Weeks 4, 8, and 12, the change in Overactive Bladder Symptom Score (OABSS) compared to baseline will be calculated.
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
PPBC-S Compared to Baseline
At the end of Weeks 4, 8, and 12, the change in Patient Perception of Bladder C Scale (PPBC-S) compared to baseline will be calculated.
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
AUA-SI-QOL Compared to Baseline
At the end of Weeks 4, 8, and 12, the change in American Urological Association- Symptom Index-Quality of life (AUA-SI-QOL) compared to baseline will be calculated.
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
SAS Compared to Baseline
At the end of Weeks 4, 8, and 12, the change in Self-Rating Anxiety Scale (SAS) compared to baseline will be calculated.
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Participant Satisfaction
At the end of Weeks 4, 8, and 12, participant satisfaction will be assessed using a participant satisfaction questionnaire
Measured: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Potential Adverse Events Related by TTNS
During the study, information on potential adverse events related to TTNS will be recorded, including pain and infection at the stimulation site, tibial nerve injury (such as motor dysfunction, neuralgia, etc.), urinary system complications (such as urinary retention), and other adverse events that the investigator deems potentially related to TTNS."
Measured: Entire Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia SurgeryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qing Yuan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558539
- Sponsor's protocol ID
- TTNS2024
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Wearable Transcutaneous Tibial Nerve Stimulation for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
- ClinicalTrials.gov ID
- NCT06558539
- Acronym / sponsor ID
- TTNS2024
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Qing YuanUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 16 Aug 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.
A single-center, randomized, parallel-controlled design. Approximately 90 cases of persistent overactive bladder symptoms post benign prostatic hyperplasia surgery are expected to be enrolled. The study participants will be randomly assigned to three groups, with 30 participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Combination Product: Combination TherapyApproximately 30 participants are expected to be enrolled, and they will receive a combination of standard medication and TTNS therapy for 12 weeks. |
| TTNS | Experimental | Device: Transcutaneous Tibial Nerve Stimulation(TTNS)Approximately 30 participants are expected to be enrolled, and they will receive TTNS therapy for 12 weeks. |
| Standard Medication Therapy | Active comparator | Drug: Standard Medication TherapyApproximately 30 participants are expected to be enrolled, and they will receive standard medication and TTNS therapy for 12 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with overactive bladder before benign prostatic hyperplasia 2.Overactive bladder still exists 1 month after the operation of benign prostatic hyperplasia; 3.50 ≤ age ≤80 , male 4.72-hour urination diary showed an average of ≥8 urination times every 24 hours at baseline
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulation(TTNS)Participants in this group will discontinue all relevant medications (e.g., β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs) at least 14 days before signing the informed consent and will not use these medications during the study period. They will receive treatment solely with wearable transcutaneous tibial nerve stimulation. | Device | TTNS |
| Combination TherapyParticipants in this group will continue their prescribed medication regimen, which may include β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs, with dosages and administration unchanged throughout the study. In addition to the standard medication therapy, participants will receive wearable transcutaneous tibial nerve stimulation using a wearable device | Combination product | Combination Therapy |
| Standard Medication TherapyParticipants in this group will maintain their usual medication regimen, which may include β3-adrenergic agonists, non-selective β-adrenergic agonists, or anticholinergic drugs, with dosages and administration remaining consistent throughout the study. No additional interventions will be provided. | Drug | Standard Medication Therapy |
Primary outcome
Average Daily Urination Frequency Compared to Baseline
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
At the end of Weeks 4, 8, and 12, the change in average daily urination frequency compared to baseline will be calculated using the participants' 72-hour voiding diaries
10 secondary outcomes
Average Urinary Urgency Score
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Average Daily Nocturia Frequency Compared to Baseline
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Average Voided Volume per Urination Compared to Baseline
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Average Daily Incontinence Episodes
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
OABSS Compared to Baseline
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
PPBC-S Compared to Baseline
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
AUA-SI-QOL Compared to Baseline
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
SAS Compared to Baseline
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Participant Satisfaction
Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Potential Adverse Events Related by TTNS
Time frame: Entire Study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcutaneous Tibial Nerve Stimulation(TTNS), Combination Therapy and Standard Medication Therapy in people with Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery, run by Qing Yuan.
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: status not confirmed, as of the sponsor's last update on 16 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qing Quan (86+18910980422, Qyuanmd@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Urination Frequency Compared to Baseline (time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.). 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 16 Aug 2024.