Tibial Nerve Stimulation for Post-BPH Overactive Bladder
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age50-80
SponsorQing Yuan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Tibial Nerve Stimulation(TTNS)
DeviceParticipants 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 Therapy
Combination productParticipants 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 Therapy
DrugParticipants 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Combination TherapyExperimental treatment 1 intervention
Group B: TTNSExperimental treatment 1 intervention
Group C: Standard Medication TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
treatment during 12 weeks : assessments at weeks 4, 8, and 12.Secondary outcomes
1
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
Time frame
treatment during 12 weeks : assessments at weeks 4, 8, and 12.2
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
Time frame
treatment during 12 weeks : assessments at weeks 4, 8, and 12.3
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
Time frame
treatment during 12 weeks : assessments at weeks 4, 8, and 12.4
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
Time frame
treatment during 12 weeks : assessments at weeks 4, 8, and 12.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Qing Yuan
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov
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