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.
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;
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;
Parallel
bilateral sacral nerve stimulation (BNS)
DeviceParticipants 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.
Standardized 72-hour voiding diary
Standardized 72-hour voiding diary, record the frequency of daily urination and incontinence over a period of three days
Standardized 72-hour voiding diary
Standardized 72-hour voiding diary, record the volume of each urination and catheterization (ml) within three days
Standardized 72-hour defecation diary
Standardized 72-hour defecation diary, indicating stool characteristics and incontinence time
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.
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.
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).
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