Bilateral Comparison of Unilateral Sacral Neuromodulation Test Stimulation in the Treatment of Neurogenic Bladder

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurogenic Bladder
• Intervention / Treatment: Device: bilateral sacral nerve stimulation (BNS)

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:

1. basic information of patients, including age, gender, history of smoking and alcohol, spinal cord lesions, lower urinary tract dysfunction symptoms, and medication history;
2. Standardized 72-hour voiding diary, including catheterization time, fluid intake and time, incontinence time and 24-hour pad weight test;
3. Standardized 72-hour defecation diary, indicating stool characteristics and incontinence time;
4. list of currently used drugs;
5. Neurogenic bladder symptom score (NBSS);
6. The 12-item short form Health Survey (SF-12);
7. neurogenic bowel dysfunction score (NBDS);
8. Visual Analogue Scale (VAS score);
9. urinary ultrasound;
10. baseline urodynamic examination;
11. 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 Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Li, Doctor; Phone Number: 18560089113; Email: yanli@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University
      • Contact: Yan Li, Doctor; Phone Number: 18560089113; Email: yanli@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. age ≥16 years old;
2. The nerve injury was incomplete injury below grade B, which was diagnosed as neurogenic bladder;
3. 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).
4. Intermittent catheterization (CIC) can be performed by themselves or CIC can be performed by nursing staff;
5. the patient's physical condition is stable and can be discharged for treatment;
6. Participants voluntarily participated in the clinical study, and they provided written informed consent before the study began

Exclusion Criteria:

1. Patients can not perform intermittent catheterization (CIC) by themselves and there is no nursing staff to perform CIC;
2. a history of progressive neurological disorders;
3. abnormal autonomic reflexes;
4. pregnant, lactating women, women of childbearing age who plan to become pregnant during the study period, or who do not use safe contraception;
5. patients with mental and cognitive impairment who are unable to cooperate with surgery and programming;
6. patients have coagulopathy or need anticoagulant therapy and cannot stop the treatment;
7. any serious complications or illnesses that may prevent the patient from participating in or increase the patient's risk of undergoing a surgical procedure;
8. Participants who participated in other clinical trials within 3 months before screening, which may have affected the study results;
9. other conditions considered by the investigator to be inappropriate for study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unilateral-Bilateral (A); 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.	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, and in group B, bilateral stimulation was performed followed by unilateral stimulation.
Experimental: Bilateral-Unilateral (B); 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.	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, and in group B, bilateral stimulation was performed followed by unilateral stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized 72-hour voiding diary	Standardized 72-hour voiding diary, record the frequency of daily urination and incontinence over a period of three days	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	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized 72-hour defecation diary	Standardized 72-hour defecation diary, indicating stool characteristics and incontinence time	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.	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.	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).	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).	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.	From enrollment to the end of treatment at 1 year

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Chair: Lipeng Chen, Doctor, Qilu Hospital of Shandong University

Publications and helpful links

General 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.
• Kim 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.
• Chen 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.
• Wollner 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.
• Agnello 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: sacral neuromodulation; neurogenic bladder
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Neurogenic
• Other Study ID Numbers: KYLL-202504-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No