Rechargeable Sacral Neuromodulation DeviceSNM、NLUTDNCT07173517
Cost Profile and Budget Implications of Rechargeable Versus Non-rechargeable Sacral Neuromodulation Devices for Neurogenic Lower Urinary Tract Dysfunction
An observational study of Rechargeable Sacral Neuromodulation Device and Neurogenic Lower Urinary Tract Dysfunction, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rechargeable Sacral Neuromodulation Device, Neurogenic Lower Urinary Tract Dysfunction
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: They were treated with rechargeable or non-rechargeable sacral neuromodulation devices
Who may be able to join
- male and female patients with neurogenic lower urinary tract dysfunction who had failed conventional treatment
- obstructive urinary retention and contraindications to SNM
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital
Jinan, Shandong
Hui Chen, +86 53182165409, qlyykyll@163.com
About this study
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.
Read the 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.
- Keywords
- neurogenic lower urinary tract dysfunction, cost-savings, sacral neuromodulation, rechargeable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| rechargeable group | Not described | |
| non-rechargeable group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs associated with sacral neuromodulation therapy
Costs associated with sacral neuromodulation therapy
Measured: From August 2020 to January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rechargeable Sacral Neuromodulation DeviceStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Aerospace Center Hospital, Shandong Provincial Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Beijing Hospital, Xi'an Honghui Hospital, The First Affiliated Hospital of Zhengzhou University, Second Hospital of Jilin University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tongji Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173517
- Sponsor's protocol ID
- KYLL-202505-101
- Acronym
- SNM、NLUTD
- Status last verified
- Jul 2025
- First submitted
- 7 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Profile and Budget Implications of Rechargeable Versus Non-rechargeable Sacral Neuromodulation Devices for Neurogenic Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT07173517
- Acronym / sponsor ID
- SNM、NLUTD / KYLL-202505-101
- Keywords
- neurogenic lower urinary tract dysfunction, cost-savings, sacral neuromodulation, rechargeable
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Aerospace Center Hospital, Shandong Provincial Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Beijing Hospital, Xi'an Honghui Hospital, The First Affiliated Hospital of Zhengzhou University, Second Hospital of Jilin University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tongji Hospital
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rechargeable group | – | – |
| non-rechargeable group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- They were treated with rechargeable or non-rechargeable sacral neuromodulation devices
Key inclusion criteria (2 listed)
- male and female patients with neurogenic lower urinary tract dysfunction who had failed conventional treatment
- obstructive urinary retention and contraindications to SNM
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Costs associated with sacral neuromodulation therapy
Time frame: From August 2020 to January 2025
Costs associated with sacral neuromodulation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rechargeable Sacral Neuromodulation Device and Neurogenic Lower Urinary Tract Dysfunction, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Li, Ph.D degree (+86 18560089113, yanli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs associated with sacral neuromodulation therapy (time frame: From August 2020 to January 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.