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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| TTNS | Experimental | Approximately 30 participants are expected to be enrolled, and they will receive TTNS therapy for 12 weeks. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | treatment during 12 weeks : assessments at weeks 4, 8, and 12. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | treatment during 12 weeks : assessments at weeks 4, 8, and 12. |
| Average Daily Nocturia Frequency Compared to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Quan | Contact | 86+18910980422 | Qyuanmd@outlook.com |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Combination Therapy | Combination 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 |
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| Standard Medication Therapy | Drug | 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. |
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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 |
| 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 | 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 | 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. | 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. | 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. | 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. | 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 | 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." | Entire Study |