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

Official title

Bilateral Comparison of Unilateral Sacral Neuromodulation Test Stimulation in the Treatment of Neurogenic Bladder: A Prospective, Randomized Controlled Study

Overview

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:

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.

Interventions

• 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.

Primary outcome measures

• Standardized 72-hour voiding diary [Time frame: From enrollment to the end of treatment at 4 weeks]
• Standardized 72-hour voiding diary [Time frame: From enrollment to the end of treatment at 4 weeks]

Secondary outcome measures (6)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Qilu Hospital of Shandong University — Jinan

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. PMID 20934242
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07505940 · KYLL-202504-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗