Tibial Nerve Stimulation for Post-BPH Overactive Bladder
- Conditions
- Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
- Registration Number
- NCT06558539
- Lead Sponsor
- Qing Yuan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 90
-
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Average Daily Urination Frequency Compared to Baseline 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
- Secondary Outcome Measures
Name Time Method OABSS Compared to Baseline treatment during 12 weeks : assessments at weeks 4, 8, and 12. At the end of Weeks 4, 8, and 12, the change in Overactive Bladder Symptom Score (OABSS) compared to baseline will be calculated.
Average Daily Nocturia Frequency Compared to Baseline 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 nocturia frequency compared to baseline will be calculated using the participants' 72-hour voiding diaries
Average Voided Volume per Urination Compared to Baseline treatment during 12 weeks : assessments at weeks 4, 8, and 12. 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
Average Urinary Urgency Score treatment during 12 weeks : assessments at weeks 4, 8, and 12. At the end of Weeks 4, 8, and 12, the average urinary urgency score will be calculated using the participants' 72-hour voiding diaries
SAS Compared to Baseline treatment during 12 weeks : assessments at weeks 4, 8, and 12. At the end of Weeks 4, 8, and 12, the change in Self-Rating Anxiety Scale (SAS) compared to baseline will be calculated.
Potential Adverse Events Related by TTNS Entire Study 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."
Average Daily Incontinence Episodes treatment during 12 weeks : assessments at weeks 4, 8, and 12. At the end of Weeks 4, 8, and 12, the average daily incontinence episodes will be calculated using the participants' 72-hour voiding diaries
AUA-SI-QOL Compared to Baseline treatment during 12 weeks : assessments at weeks 4, 8, and 12. 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.
PPBC-S Compared to Baseline treatment during 12 weeks : assessments at weeks 4, 8, and 12. 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.
Participant Satisfaction treatment during 12 weeks : assessments at weeks 4, 8, and 12. At the end of Weeks 4, 8, and 12, participant satisfaction will be assessed using a participant satisfaction questionnaire