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NCT Number: NCT07173517

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

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.

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Key information

Conditions

Rechargeable Sacral Neuromodulation Device Neurogenic Lower Urinary Tract Dysfunction

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Costs associated with sacral neuromodulation therapy

    Time frame: From August 2020 to January 2025

    Costs associated with sacral neuromodulation therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Li, Ph.D degree

CONTACT

[email protected]

+86 18560089113

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Aerospace Center Hospital
  • Beijing Hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Second Hospital of Jilin University
  • Shandong Provincial Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital of Zhengzhou University
  • Tongji Hospital
  • Xi'an Honghui Hospital

Registry information

Acronym: SNM、NLUTD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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