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Not yet recruiting NCT06558539

Tibial Nerve Stimulation for Post-BPH Overactive Bladder

Phase III Interventional Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Tibial Nerve Stimulation(TTNS), Combination Therapy, Standard Medication Therapy.
Who it may be relevant to
Registry conditions: Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery. Basic parameters: 50 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study on the Efficacy of Wearable Transcutaneous Tibial Nerve Stimulation for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery

Overview

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

  • Device Transcutaneous 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 product Combination 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
  • Drug Standard Medication Therapy
    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.

Primary outcome measures

  • Average Daily Urination Frequency Compared to Baseline [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
Secondary outcome measures (10)
  • Average Urinary Urgency Score [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • Average Daily Nocturia Frequency Compared to Baseline [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • Average Voided Volume per Urination Compared to Baseline [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • Average Daily Incontinence Episodes [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • OABSS Compared to Baseline [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • PPBC-S Compared to Baseline [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • AUA-SI-QOL Compared to Baseline [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • SAS Compared to Baseline [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • Participant Satisfaction [Time frame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.]
  • Potential Adverse Events Related by TTNS [Time frame: Entire Study]

Eligibility criteria

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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06558539 · TTNS2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗