Tibial Nerve Stimulation for Post-BPH Overactive Bladder
NCT Number: NCT06558539
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
Sponsor: Qing Yuan
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-02

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.

Primary Outcome Measures: 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.
Secondary Outcome Measures: 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, 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