Neurogenic BladderNCT07505940
Bilateral Comparison of Unilateral Sacral Neuromodulation Test Stimulation in the Treatment of Neurogenic Bladder
A study testing bilateral sacral nerve stimulation (BNS) in people with Neurogenic Bladder, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Neurogenic bladder (NB) is a general term for a series of lower urinary tract symptoms and complications caused by bladder and/or urethral dysfunction caused by nervous system lesions. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- bilateral sacral nerve stimulation (BNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 1 Mar 2027
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age ≥16 years old;
- The nerve injury was incomplete injury below grade B, which was diagnosed as neurogenic bladder;
- Overactive bladder with and/or low compliance bladder (overactive bladder was defined as detrusor contraction during filling, increased intravesical pressure, and early emptying before maximum bladder capacity was reached; Low compliance bladder was defined as loss of the ability to relax during bladder filling, progressive increase of bladder pressure, early emptying of bladder pressure increased, ≤20ml/cmH20).
- Intermittent catheterization (CIC) can be performed by themselves or CIC can be performed by nursing staff;
- the patient's physical condition is stable and can be discharged for treatment;
- Participants voluntarily participated in the clinical study, and they provided written informed consent before the study began
Who cannot join
- Patients can not perform intermittent catheterization (CIC) by themselves and there is no nursing staff to perform CIC;
- a history of progressive neurological disorders;
- abnormal autonomic reflexes;
- pregnant, lactating women, women of childbearing age who plan to become pregnant during the study period, or who do not use safe contraception;
- patients with mental and cognitive impairment who are unable to cooperate with surgery and programming;
- patients have coagulopathy or need anticoagulant therapy and cannot stop the treatment;
Show all 9Show fewer
- any serious complications or illnesses that may prevent the patient from participating in or increase the patient's risk of undergoing a surgical procedure;
- Participants who participated in other clinical trials within 3 months before screening, which may have affected the study results;
- other conditions considered by the investigator to be inappropriate for study participation.
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 of Shandong University
Jinan, Shandong
Yan Li, Doctor, 18560089113, yanli@sdu.edu.cn
About this study
Official title: Bilateral Comparison of Unilateral Sacral Neuromodulation Test Stimulation in the Treatment of Neurogenic Bladder: A Prospective, Randomized Controlled Study
Neurogenic bladder (NB) is a general term for a series of lower urinary tract symptoms and complications caused by bladder and/or urethral dysfunction caused by nervous system lesions. Neurogenic bladder brings physical and psychological pain to patients, affects interpersonal relationships, and seriously reduces the quality of life of patients.
Sacral neuromodulation (SNM) is an effective method for the treatment of refractory lower urinary tract dysfunction. A previous study analyzed bilateral peripheral nerve evaluation (PNE) in 62 patients with idiopathic and neurogenic bladder. The results of this clinical study showed that 51.6% of the patients (32 cases) achieved symptomatic improvement. Although a prospective controlled study was not performed, the authors suggest that bilateral treatment may improve symptoms in patients with idiopathic and neurogenic bladder compared with unilateral treatment, compared with remission rates in other previous clinical studies.
At present, there are few reports on the application of bilateral sacral neuromodulation stimulation in the treatment of voiding dysfunction, and it is still controversial whether the efficacy of bilateral stimulation is better than unilateral stimulation. Therefore, we intend to conduct a prospective, randomized controlled trial to evaluate the efficacy and safety of bilateral sacral neuromodulation test stimulation in the treatment of neurogenic lower urinary tract dysfunction.
Read the detailed description
A preoperative voiding diary (including daily voiding frequency, secondary voiding volume, urgency score, and daily urinary incontinence episodes) and urodynamic findings were recorded as baseline reference. Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group A, unilateral stimulation was performed followed by bilateral stimulation, and in group B, bilateral stimulation was performed followed by unilateral stimulation. Voiding diary and urodynamic examination results were recorded during the whole test treatment period, and the improvement of voiding symptoms (frequency, urgency, urge urinary incontinence, etc.) was analyzed during each stimulation period.
Baseline data of all study participants were collected at the time of enrollment:
- basic information of patients, including age, gender, history of smoking and alcohol, spinal cord lesions, lower urinary tract dysfunction symptoms, and medication history;
- Standardized 72-hour voiding diary, including catheterization time, fluid intake and time, incontinence time and 24-hour pad weight test;
- Standardized 72-hour defecation diary, indicating stool characteristics and incontinence time;
- list of currently used drugs;
- Neurogenic bladder symptom score (NBSS);
- The 12-item short form Health Survey (SF-12);
- neurogenic bowel dysfunction score (NBDS);
- Visual Analogue Scale (VAS score);
- urinary ultrasound;
- baseline urodynamic examination;
- Renal function test. Follow-up or repeat visits occurred 7, 16, and 25 days after enrollment. (1) A standardized 72-hour voiding diary was collected at each visit, indicating the time of catheter insertion, fluid intake and timing, incontinence duration, and 24-hour pad weight test; (2) Standardized 72-hour defecation diary, indicating stool characteristics and incontinence time; (3) list of currently used drugs; (4) Neurogenic bladder symptom score (NBSS); (5) The 12-item short form health Survey (SF-12); (6) Neurogenic bowel dysfunction score (NBDS); (7) Visual Analogue Scale (VAS score); (8) Urinary tract infection and adverse events. Participants were followed up at 12 months for ultrasound, urodynamic studies, and/or renal function tests.
- Conditions
- Neurogenic Bladder
- Being tested
- bilateral sacral nerve stimulation (BNS)
- Keywords
- neurogenic bladder, sacral neuromodulation
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral sacral nerve stimulation (BNS)Device
Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group A, unilateral stimulation was performed followed by bilateral stimulation, and in group B, bilateral stimulation was performed followed by unilateral stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral-Bilateral (A) | Experimental | Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group A, unilateral stimulation was performed followed by bilateral stimulation. Receives: Device: bilateral sacral nerve stimulation (BNS) |
| Bilateral-Unilateral (B) | Experimental | Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group B, bilateral stimulation was performed followed by unilateral stimulation. Receives: Device: bilateral sacral nerve stimulation (BNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized 72-hour voiding diary
Standardized 72-hour voiding diary, record the frequency of daily urination and incontinence over a period of three days
Measured: From enrollment to the end of treatment at 4 weeks
Standardized 72-hour voiding diary
Standardized 72-hour voiding diary, record the volume of each urination and catheterization (ml) within three days
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (6)
Standardized 72-hour defecation diary
Standardized 72-hour defecation diary, indicating stool characteristics and incontinence time
Measured: From enrollment to the end of treatment at 4 weeks
Neurogenic bladder symptom score (NBSS)
Neurogenic bladder symptom score (NBSS):The NBSS included 3 dimensions: urinary incontinence (8 items), urine storage and voiding (7 items), and outcome (7 items), with a total of 24 items. There were two unscored items, the first item was classified according to the patient's bladder management method, and the last item was the patient's overall quality of life evaluation. To assess patient voiding patterns and quality of life. Each item was scored 0-3 points or 0-4 points. The total score on the scale is 74, with higher scores indicating more pronounced neurogenic bladder symptoms.
Measured: From enrollment to the end of treatment at 4 weeks
The 12-item short form health Survey (SF-12)
SF-12 is a simplified health-related quality of life assessment tool derived from SF-36. It contains 12 items and assesses the quality of life in 8 dimensions from two aspects: physical health (PCS) and mental health (MCS).
Dimension score calculation: A specific algorithm was used to convert the original scores of 12 items into scores of 8 domains, including general health, physical functioning, role physical, bodily pain, vitality, social functioning, role emotional and mental health. Scores for each domain typically range from 0 to 100, with higher scores indicating better health status in that domain.
Measured: From enrollment to the end of treatment at 4 weeks
Neurogenic bowel dysfunction score (NBDS)
Neurogenic bowel dysfunction score (NBDS):
The NBDS, which assesses both constipation and fecal incontinence symptoms, was used to assess the severity of clinical colorectal dysfunction in patients with spinal cord injury, with total scores ranging from 0 to 47, with higher scores indicating more severe bowel symptoms. The severity of NBD was classified into four grades based on the NBD score: very mild (0-6), mild (7-9), moderate (10-13), and severe (14 and above).
Measured: From enrollment to the end of treatment at 4 weeks
VAS score
VAS score:The visual analogue scale (VAS) is a clinical assessment tool that quantizes pain intensity using a linear scale about 10 cm long, with two ends of the scale marked "0" (no pain) and "10" (severe pain).
Measured: From enrollment to the end of treatment at 4 weeks
Urinary tract infection and adverse events
Urinary tract infection and adverse events:Participants were followed up at 12 months for ultrasound, urodynamic studies, and/or renal function tests.
Measured: From enrollment to the end of treatment at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start31 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurogenic BladderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lipeng Chen, Doctor, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505940
- Sponsor's protocol ID
- KYLL-202504-002
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kessler TM, La Framboise D, Trelle S, Fowler CJ, Kiss G, Pannek J, Schurch B, Sievert KD, Engeler DS. Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis. Eur Urol. 2010 Dec;58(6):865-74. doi: 10.1016/j.eururo.2010.09.024. Epub 2010 Oct 1.
PubMed 20934242Kim JH, Ahn SH, Cho YW, Kwak SG, Kim HS. Short-Term Effect of Percutaneous Bipolar Continuous Radiofrequency on Sacral Nerves in Patients Treated for Neurogenic Detrusor Overactivity After Spinal Cord Injury: A Randomized Controlled Feasibility Study. Ann Rehabil Med. 2015 Oct;39(5):718-25. doi: 10.5535/arm.2015.39.5.718. Epub 2015 Oct 26.
PubMed 26605169Chen G, Liao L, Wang Y, Ying X. Urodynamic findings during the filling phase in neurogenic bladder patients with or without vesicoureteral reflux who have undergone sacral neuromodulation. Neurourol Urodyn. 2020 Jun;39(5):1410-1416. doi: 10.1002/nau.24354. Epub 2020 Apr 13.
PubMed 32282088Wollner J, Krebs J, Pannek J. Sacral neuromodulation in patients with neurogenic lower urinary tract dysfunction. Spinal Cord. 2016 Feb;54(2):137-40. doi: 10.1038/sc.2015.124. Epub 2015 Jul 28.
PubMed 26215913Agnello M, Vottero M, Bertapelle P. Sacral neuromodulation to treat voiding dysfunction in patients with previous pelvic surgery for deep infiltrating endometriosis: our centre's experience. Int Urogynecol J. 2021 Jun;32(6):1499-1504. doi: 10.1007/s00192-020-04478-z. Epub 2020 Aug 15.
PubMed 32803341
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Comparison of Unilateral Sacral Neuromodulation Test Stimulation in the Treatment of Neurogenic Bladder: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07505940
- Acronym / sponsor ID
- KYLL-202504-002
- Conditions
- Neurogenic Bladder
- Keywords
- neurogenic bladder, sacral neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 1 Apr 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.
Neurogenic bladder (NB) is a general term for a series of lower urinary tract symptoms and complications caused by bladder and/or urethral dysfunction caused by nervous system lesions. Neurogenic bladder brings physical and psychological pain to patients, affects interpersonal relationships, and seriously reduces the quality of life of patients.
Sacral neuromodulation (SNM) is an effective method for the treatment of refractory lower urinary tract dysfunction. A previous study analyzed bilateral peripheral nerve evaluation (PNE) in 62 patients with idiopathic and neurogenic bladder. The results of this clinical study showed that 51.6% of the patients (32 cases) achieved symptomatic improvement. Although a prospective controlled study was not performed, the authors suggest that bilateral treatment may improve symptoms in patients with idiopathic and neurogenic bladder compared with unilateral treatment, compared with remission rates in other previous clinical studies.
At present, there are few reports on the application of bilateral sacral neuromodulation stimulation in the treatment of voiding dysfunction, and it is still controversial whether the efficacy of bilateral stimulation is better than unilateral stimulation. Therefore, we intend to conduct a prospective, randomized controlled trial to evaluate the efficacy and safety of bilateral sacral neuromodulation test stimulation in the treatment of neurogenic lower urinary tract dysfunction.
Detailed description
A preoperative voiding diary (including daily voiding frequency, secondary voiding volume, urgency score, and daily urinary incontinence episodes) and urodynamic findings were recorded as baseline reference. Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group A, unilateral stimulation was performed followed by bilateral stimulation, and in group B, bilateral stimulation was performed followed by unilateral stimulation. Voiding diary and urodynamic examination results were recorded during the whole test treatment period, and the improvement of voiding symptoms (frequency, urgency, urge urinary incontinence, etc.) was analyzed during each stimulation period.
Baseline data of all study participants were collected at the time of enrollment:
- basic information of patients, including age, gender, history of smoking and alcohol, spinal cord lesions, lower urinary tract dysfunction symptoms, and medication history;
- Standardized 72-hour voiding diary, including catheterization time, fluid intake and time, incontinence time and 24-hour pad weight test;
- Standardized 72-hour defecation diary, indicating stool characteristics and incontinence time;
- list of currently used drugs;
- Neurogenic bladder symptom score (NBSS);
- The 12-item short form Health Survey (SF-12);
- neurogenic bowel dysfunction score (NBDS);
- Visual Analogue Scale (VAS score);
- urinary ultrasound;
- baseline urodynamic examination;
- Renal function test. Follow-up or repeat visits occurred 7, 16, and 25 days after enrollment. (1) A standardized 72-hour voiding diary was collected at each visit, indicating the time of catheter insertion, fluid intake and timing, incontinence duration, and 24-hour pad weight test; (2) Standardized 72-hour defecation diary, indicating stool characteristics and incontinence time; (3) list of currently used drugs; (4) Neurogenic bladder symptom score (NBSS); (5) The 12-item short form health Survey (SF-12); (6) Neurogenic bowel dysfunction score (NBDS); (7) Visual Analogue Scale (VAS score); (8) Urinary tract infection and adverse events. Participants were followed up at 12 months for ultrasound, urodynamic studies, and/or renal function tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral-Bilateral (A) | Experimental | Device: bilateral sacral nerve stimulation (BNS)Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group A, unilateral stimulation was performed followed by bilateral stimulation. |
| Bilateral-Unilateral (B) | Experimental | Device: bilateral sacral nerve stimulation (BNS)Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group B, bilateral stimulation was performed followed by unilateral stimulation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥16 years old;
- The nerve injury was incomplete injury below grade B, which was diagnosed as neurogenic bladder;
- Overactive bladder with and/or low compliance bladder (overactive bladder was defined as detrusor contraction during filling, increased intravesical pressure, and early emptying before maximum bladder capacity was reached; Low compliance bladder was defined as loss of the ability to relax during bladder filling, progressive increase of bladder pressure, early emptying of bladder pressure increased, ≤20ml/cmH20).
- Intermittent catheterization (CIC) can be performed by themselves or CIC can be performed by nursing staff;
- the patient's physical condition is stable and can be discharged for treatment;
Key exclusion criteria (9 listed)
- Patients can not perform intermittent catheterization (CIC) by themselves and there is no nursing staff to perform CIC;
- a history of progressive neurological disorders;
- abnormal autonomic reflexes;
- pregnant, lactating women, women of childbearing age who plan to become pregnant during the study period, or who do not use safe contraception;
- patients with mental and cognitive impairment who are unable to cooperate with surgery and programming;
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 |
|---|---|---|
| bilateral sacral nerve stimulation (BNS)Participants underwent bilateral sacral nerve stimulation (BNS) and were randomly assigned to either group A or group B (1:1). In group A, unilateral stimulation was performed followed by bilateral stimulation, and in group B, bilateral stimulation was performed followed by unilateral stimulation. | Device | Bilateral-Unilateral (B), Unilateral-Bilateral (A) |
Primary outcome
Standardized 72-hour voiding diary
Time frame: From enrollment to the end of treatment at 4 weeks
Standardized 72-hour voiding diary, record the frequency of daily urination and incontinence over a period of three days
Standardized 72-hour voiding diary
Time frame: From enrollment to the end of treatment at 4 weeks
Standardized 72-hour voiding diary, record the volume of each urination and catheterization (ml) within three days
6 secondary outcomes
Standardized 72-hour defecation diary
Time frame: From enrollment to the end of treatment at 4 weeks
Neurogenic bladder symptom score (NBSS)
Time frame: From enrollment to the end of treatment at 4 weeks
The 12-item short form health Survey (SF-12)
Time frame: From enrollment to the end of treatment at 4 weeks
Neurogenic bowel dysfunction score (NBDS)
Time frame: From enrollment to the end of treatment at 4 weeks
VAS score
Time frame: From enrollment to the end of treatment at 4 weeks
Urinary tract infection and adverse events
Time frame: From enrollment to the end of treatment at 1 year
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 1 Apr 2026.
- Background: PubMed 20934242Kessler TM, La Framboise D, Trelle S, Fowler CJ, Kiss G, Pannek J, Schurch B, Sievert KD, Engeler DS. Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis. Eur Urol. 2010 Dec;58(6):865-74. doi: 10.1016/j.eururo.2010.09.024. Epub 2010 Oct 1.
- Background: PubMed 26605169Kim JH, Ahn SH, Cho YW, Kwak SG, Kim HS. Short-Term Effect of Percutaneous Bipolar Continuous Radiofrequency on Sacral Nerves in Patients Treated for Neurogenic Detrusor Overactivity After Spinal Cord Injury: A Randomized Controlled Feasibility Study. Ann Rehabil Med. 2015 Oct;39(5):718-25. doi: 10.5535/arm.2015.39.5.718. Epub 2015 Oct 26.
- Background: PubMed 32282088Chen G, Liao L, Wang Y, Ying X. Urodynamic findings during the filling phase in neurogenic bladder patients with or without vesicoureteral reflux who have undergone sacral neuromodulation. Neurourol Urodyn. 2020 Jun;39(5):1410-1416. doi: 10.1002/nau.24354. Epub 2020 Apr 13.
- Background: PubMed 26215913Wollner J, Krebs J, Pannek J. Sacral neuromodulation in patients with neurogenic lower urinary tract dysfunction. Spinal Cord. 2016 Feb;54(2):137-40. doi: 10.1038/sc.2015.124. Epub 2015 Jul 28.
- Background: PubMed 32803341Agnello M, Vottero M, Bertapelle P. Sacral neuromodulation to treat voiding dysfunction in patients with previous pelvic surgery for deep infiltrating endometriosis: our centre's experience. Int Urogynecol J. 2021 Jun;32(6):1499-1504. doi: 10.1007/s00192-020-04478-z. Epub 2020 Aug 15.
- Individual participant dataSharing planned: Undecided
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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.
Lipeng Chen, Doctor study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral sacral nerve stimulation (BNS) in people with Neurogenic Bladder, 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 6 inclusion and 9 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 1 Apr 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?
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, Doctor (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?
Standardized 72-hour voiding diary (time frame: From enrollment to the end of treatment at 4 weeks). 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?
On the ClinicalTrials.gov record for NCT07505940, which also lists 5 linked publications.
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 1 Apr 2026.