NCT Number: NCT06558539
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.
Trial opening soon.
Get Notified50 year–80 year
Male
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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.
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
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.
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
Time frame: 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
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 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.
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.
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.
At the end of Weeks 4, 8, and 12, the change in Overactive Bladder Symptom Score (OABSS) compared to baseline will be calculated.
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 Patient Perception of Bladder C Scale (PPBC-S) compared to baseline will be calculated.
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 American Urological Association- Symptom Index-Quality of life (AUA-SI-QOL) compared to baseline will be calculated.
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 Self-Rating Anxiety Scale (SAS) compared to baseline will be calculated.
Time frame: 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
Time frame: 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."
Contact information is provided by the study sponsor or research team.
Qing Yuan
Other
Study on the Efficacy of Wearable Transcutaneous Tibial Nerve Stimulation for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
