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

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Conditions studied: Neurogenic Bladder

In brief

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.

Key facts

Study ID

NCT07505940

Run by

Qilu Hospital of Shandong University

People needed

29

Starts

2026-03-31

Expected to finish

2027-03-01

Last updated by the study team

2026-04-01

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Qilu Hospital of Shandong University — Jinan, Shandong, China

Full record on ClinicalTrials.gov

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