Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
Conditions
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.
Interventions
DEVICETranscutaneous Tibial Nerve Stimulation(TTNS)
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.
COMBINATION_PRODUCTCombination Therapy
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.
Sponsors
Qing Yuan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. 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
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
Contacts
Primary ContactQing Quan
Outcome results
None listed