Tibial Nerve Stimulation for Post-BPH Overactive Bladder

NCT06558539 | Not Yet Recruiting Phase 3

• 1 other identifier: TTNS2024
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  treatment during 12 weeks : assessments at weeks 4, 8, and 12.

Secondary Outcomes (10)

• Average Urinary Urgency Score

  treatment during 12 weeks : assessments at weeks 4, 8, and 12.

• Average Daily Nocturia Frequency Compared to Baseline

  treatment during 12 weeks : assessments at weeks 4, 8, and 12.

• Average Voided Volume per Urination Compared to Baseline

  treatment during 12 weeks : assessments at weeks 4, 8, and 12.

• Average Daily Incontinence Episodes

  treatment during 12 weeks : assessments at weeks 4, 8, and 12.

• OABSS Compared to Baseline

  treatment during 12 weeks : assessments at weeks 4, 8, and 12.

Study Arms (3)

Combination Therapy

EXPERIMENTAL

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

TTNS

EXPERIMENTAL

Approximately 30 participants are expected to be enrolled, and they will receive TTNS therapy for 12 weeks.

Device: Transcutaneous Tibial Nerve Stimulation(TTNS)

Standard Medication Therapy

ACTIVE COMPARATOR

Approximately 30 participants are expected to be enrolled, and they will receive standard medication and TTNS therapy for 12 weeks.

Drug: Standard Medication Therapy

Interventions

Transcutaneous Tibial Nerve Stimulation(TTNS) DEVICE

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.

TTNS

Combination Therapy COMBINATION_PRODUCT

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

Combination Therapy

Standard Medication Therapy DRUG

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.

Standard Medication Therapy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

Sponsors & Collaborators

• Qing Yuan: lead

MeSH Terms

Interventions

Combined Modality Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Qing Quan

CONTACT

86+18910980422; Qyuanmd@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician of Urology

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08