Cost Profile and Budget Implications of Rechargeable Versus Non-rechargeable Sacral Neuromodulation Devices for Neurogenic Lower Urinary Tract Dysfunction

Not yet recruiting

• Conditions: Rechargeable Sacral Neuromodulation Device; Neurogenic Lower Urinary Tract Dysfunction

• Registration Number: NCT07173517
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

Traditional sacral neuromodulation devices are not rechargeable. In recent years, new rechargeable sacral neuromodulation devices have been developed and put into the market. The aim of this study was to evaluate the cost savings of a rechargeable sacral neuromodulation device versus a non-rechargeable sacral neuromodulation device for the treatment of neurogenic lower urinary tract dysfunction.

Detailed Description

From August 2020 to January 2025, 41 rechargeable and 227 non-rechargeable SNM patients with neurogenic lower urinary tract dysfunction in ten centers were enrolled in this study. Demographic data, SNM treatment-related costs, and adverse events (e.g., treatment discontinuation, infection, surgical site pain, and lead dislocation or fracture) were recorded for each patient to estimate the costs of long-term SNM treatment with rechargeable versus nonrechargeable devices.

SPSS 25.0 software was used for statistical analysis of the data. Measurement data were expressed as mean ± SD, count data were expressed as cases (%), and paired t test was used for comparison before and after treatment in the group. P \< 0.05 was considered statistically significant.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-07
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-10-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• male and female patients with neurogenic lower urinary tract dysfunction who had failed conventional treatment
• obstructive urinary retention and contraindications to SNM

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Costs associated with sacral neuromodulation therapy	From August 2020 to January 2025	Costs associated with sacral neuromodulation therapy

Trial Locations

Locations (1)

Qilu Hospital; 🇨🇳 Jinan, Shandong, China