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

NCT07505940 | Not Yet Recruiting DMC

• 1 other identifier: KYLL-202504-002
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neurogenic Bladder

Keywords

neurogenic bladder; sacral neuromodulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Standardized 72-hour defecation diary

  From enrollment to the end of treatment at 4 weeks

• Neurogenic bladder symptom score (NBSS)

  From enrollment to the end of treatment at 4 weeks

• The 12-item short form health Survey (SF-12)

  From enrollment to the end of treatment at 4 weeks

• Neurogenic bowel dysfunction score (NBDS)

  From enrollment to the end of treatment at 4 weeks

• VAS score

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

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.

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.

Device: bilateral sacral nerve stimulation (BNS)

Interventions

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.

Bilateral-Unilateral (B); Unilateral-Bilateral (A)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Related Publications (5)

• 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.

  PMID: 20934242 BACKGROUND

• 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.

  PMID: 26605169 BACKGROUND

• 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.

  PMID: 32282088 BACKGROUND

• 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.

  PMID: 26215913 BACKGROUND

• 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.

  PMID: 32803341 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lipeng Chen, Doctor

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Yan Li, Doctor

CONTACT

18560089113; yanli@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: April 1, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CN (1)