Tibial Nerve Stimulation for Post-BPH Overactive Bladder

NCT ID: NCT06558539

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Therapy

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

Group Type: EXPERIMENTAL

Combination Therapy

Intervention Type: 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

TTNS

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

Group Type: EXPERIMENTAL

Transcutaneous Tibial Nerve Stimulation(TTNS)

Intervention Type: 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.

Standard Medication Therapy

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

Group Type: ACTIVE_COMPARATOR

Standard Medication Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: DRUG

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

-

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Qing Yuan

OTHER

Sponsor Role: lead

Responsible Party

Qing Yuan

Associate Chief Physician of Urology

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Qing Quan

Role: CONTACT

Qyuanmd@outlook.com

86+18910980422

Other Identifiers

TTNS2024

Identifier Type: -

Identifier Source: org_study_id