Neurogenic Bladder, Incomplete Spinal Cord InjuryNCT07641101
Effects Of App-Supported Transitional Care On Neurogenic Bladder In Spinal Cord Injury Patients
A study testing Mobile Application Based Transitional Care and routine standardized inpatient bladder nursing in people with Neurogenic Bladder, Incomplete Spinal Cord Injury, run by Xiamen University at 1 site in China.
Trial summary
This is a single-blind randomized controlled trial for patients with neurogenic bladder after incomplete spinal cord injury. Participants are randomly divided into two groups. The control group receives routine transitional nursing and telephone follow-up, while the intervention group gets 4-week app-supported… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neurogenic Bladder, Incomplete Spinal Cord Injury
- What is being tested?
- Mobile Application Based Transitional Care and routine standardized inpatient bladder nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with neurogenic bladder secondary to incomplete spinal cord injury; Age ranging from 18 to 75 years old; Clear consciousness, capable of cooperating with nursing assessment and mobile APP follow-up management; Voluntarily sign written informed consent. -
Who cannot join
- Combined with severe renal insufficiency, malignant tumor or other life-threatening severe systemic diseases; History of previous bladder reconstructive surgery; Cognitive impairment unable to independently operate mobile APP; Refuse to continue follow-up or withdraw voluntarily during the research period.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of App-Supported Transitional Care On Bladder Function And Quality Of Life in Patients With Neurogenic Bladder After Incomplete Spinal Cord Injury: A Randomised Controlled Trial
This is a single-blind randomized controlled trial for patients with neurogenic bladder after incomplete spinal cord injury. Participants are randomly divided into two groups. The control group receives routine transitional nursing and telephone follow-up, while the intervention group gets 4-week app-supported transitional care including health education, bladder recording and online consultation. After intervention, bladder residual urine, urinary tract infection rate, self-care ability and quality of life are compared between two groups.
Read the detailed description
Neurogenic bladder is a common complication after incomplete spinal cord injury, which easily leads to recurrent urinary tract infection and decreased quality of daily life. Traditional transitional follow-up is limited by time and space. This study adopts single-blind parallel-group RCT design. Eligible patients are randomly allocated at a 1:1 ratio. Control group receives standard inpatient nursing plus conventional post-discharge follow-up; intervention group receives identical inpatient care plus systematic app-based transitional care for 4 weeks. Primary outcomes are post-void residual urine volume and urinary tract infection incidence. Secondary outcomes contain self-care ability and quality of life assessed by standardized scales. All indicators are tested at baseline and 4 weeks after intervention to verify the clinical effect of app-assisted transitional nursing.
- Being tested
- Mobile Application Based Transitional Care, routine standardized inpatient bladder nursing
- Keywords
- Transitional Care, Mobile Application, Quality of Life, Randomized Controlled Trial, Spinal Cord Injury
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application Based Transitional CareBehavioural
Four-week continuous transitional nursing service via mobile APP for patients with neurogenic bladder after incomplete spinal cord injury, including disease-related health education, real-time voiding record, regular nursing reminder and online one-on-one nurse consultation, which differs from routine single telephone follow-up in control group.
routine standardized inpatient bladder nursingOther
routine standardized inpatient bladder nursing
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients receive routine standardized inpatient bladder nursing, only one-time routine telephone follow-up after discharge without APP-based transitional care intervention Receives: Other: routine standardized inpatient bladder nursing |
| Intervention Group | Experimental | Same routine inpatient nursing as control group plus 4 weeks of systematic APP-supported transitional care including health education, voiding record management and online nurse consultation. Receives: Behavioral: Mobile Application Based Transitional Care; Other: routine standardized inpatient bladder nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urinary tract infection
Count the occurrence of urinary tract infection within 4-week follow-up and calculate infection incidence of each group.
Measured: Within 4 weeks after subject enrollment
Post-void residual urine volume
Bladder residual urine volume is measured by ultrasonic examination at baseline and after 4 weeks of nursing intervention to compare the difference between two groups.
Measured: Baseline and 4 weeks after intervention
Secondary outcomes (1)
Self-care ability and quality of life score
Standardized scale scoring for self-care and quality of life before and after 4-week transitional nursing.
Measured: Baseline and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start10 Jan 2026
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Bladder, Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tian Zhang, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641101
- Sponsor's protocol ID
- SKYLW-2024-001
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant raw data will not be shared publicly due to patient privacy protection and relevant hospital data management regulations.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of App-Supported Transitional Care On Bladder Function And Quality Of Life in Patients With Neurogenic Bladder After Incomplete Spinal Cord Injury: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07641101
- Acronym / sponsor ID
- SKYLW-2024-001
- Keywords
- Transitional Care, Mobile Application, Quality of Life, Randomized Controlled Trial, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 11 Jun 2026 (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.
This is a single-blind randomized controlled trial for patients with neurogenic bladder after incomplete spinal cord injury. Participants are randomly divided into two groups. The control group receives routine transitional nursing and telephone follow-up, while the intervention group gets 4-week app-supported transitional care including health education, bladder recording and online consultation. After intervention, bladder residual urine, urinary tract infection rate, self-care ability and quality of life are compared between two groups.
Detailed description
Neurogenic bladder is a common complication after incomplete spinal cord injury, which easily leads to recurrent urinary tract infection and decreased quality of daily life. Traditional transitional follow-up is limited by time and space. This study adopts single-blind parallel-group RCT design. Eligible patients are randomly allocated at a 1:1 ratio. Control group receives standard inpatient nursing plus conventional post-discharge follow-up; intervention group receives identical inpatient care plus systematic app-based transitional care for 4 weeks. Primary outcomes are post-void residual urine volume and urinary tract infection incidence. Secondary outcomes contain self-care ability and quality of life assessed by standardized scales. All indicators are tested at baseline and 4 weeks after intervention to verify the clinical effect of app-assisted transitional nursing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: routine standardized inpatient bladder nursingPatients receive routine standardized inpatient bladder nursing, only one-time routine telephone follow-up after discharge without APP-based transitional care intervention |
| Intervention Group | Experimental | Behavioral: Mobile Application Based Transitional Care, Other: routine standardized inpatient bladder nursingSame routine inpatient nursing as control group plus 4 weeks of systematic APP-supported transitional care including health education, voiding record management and online nurse consultation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with neurogenic bladder secondary to incomplete spinal cord injury; Age ranging from 18 to 75 years old; Clear consciousness, capable of cooperating with nursing assessment and mobile APP follow-up management; Voluntarily sign written informed consent. -
Key exclusion criteria (2 listed)
- Combined with severe renal insufficiency, malignant tumor or other life-threatening severe systemic diseases; History of previous bladder reconstructive surgery; Cognitive impairment unable to independently operate mobile APP; Refuse to continue follow-up or withdraw voluntarily during the research period.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Application Based Transitional CareFour-week continuous transitional nursing service via mobile APP for patients with neurogenic bladder after incomplete spinal cord injury, including disease-related health education, real-time voiding record, regular nursing reminder and online one-on-one nurse consultation, which differs from routine single telephone follow-up in control group. | Behavioural | Intervention Group |
| routine standardized inpatient bladder nursingroutine standardized inpatient bladder nursing | Other | Control Group, Intervention Group |
Primary outcome
Incidence of urinary tract infection
Time frame: Within 4 weeks after subject enrollment
Count the occurrence of urinary tract infection within 4-week follow-up and calculate infection incidence of each group.
Post-void residual urine volume
Time frame: Baseline and 4 weeks after intervention
Bladder residual urine volume is measured by ultrasonic examination at baseline and after 4 weeks of nursing intervention to compare the difference between two groups.
1 secondary outcome
Self-care ability and quality of life score
Time frame: Baseline and 4 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant raw data will not be shared publicly due to patient privacy protection and relevant hospital data management regulations.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application Based Transitional Care and routine standardized inpatient bladder nursing in people with Neurogenic Bladder, Incomplete Spinal Cord Injury, run by Xiamen 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 11 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urinary tract infection (time frame: Within 4 weeks after subject enrollment). The study lists 2 primary outcomes in all. 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 11 Jun 2026.