Tibial Nerve Stimulation for Post-BPH Overactive Bladder

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qing Quan; Phone Number: 86+18910980422; Email: Qyuanmd@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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.	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.	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.	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.	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	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."	Entire Study

Collaborators and Investigators

• Sponsor: Qing Yuan

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: TTNS2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No