A Phase 3 interventional study of Transcutaneous Tibial Nerve Stimulation(TTNS) and Combination Therapy in Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery, sponsored by Qing Yuan. Not yet recruiting. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Qing Yuan · Phase 3, Interventional, and Treatment
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.
828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 90 is close to the median of 92 across 627 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Qing Yuan is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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Approximately 30 participants are expected to be enrolled, and they will receive a combination of standard medication and TTNS therapy for 12 weeks.
Combination Product: Combination Therapy
Approximately 30 participants are expected to be enrolled, and they will receive TTNS therapy for 12 weeks.
Device: Transcutaneous Tibial Nerve Stimulation(TTNS)
Approximately 30 participants are expected to be enrolled, and they will receive standard medication and TTNS therapy for 12 weeks.
Drug: Standard Medication Therapy
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.
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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."
Time frame: Entire Study
No study locations are listed for this record.
Start is estimated for Sep 2024; primary completion for Feb 2025, 5 months later.
Of 17 phase 3 interventional studies under Prostatic Hyperplasia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 50. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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