Neurogenic bladder
Conditions
Interventions
Intervention group:Sacral Neuromodulation
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age over 18 years old, no gender limit; (2) Diagnosis of neurogenic bladder due to spinal cord injury; (3) Urodynamic examination was performed, and low compliance bladder was defined as loss of ability to relax when the bladder is full, progressive increase in bladder pressure, and early emptied due to elevated bladder pressure, 100ml; (6) Patients evaluated for surgical treatment of sacral neuromodulation; (7) If no drug therapy is planned during the study period, the drug should be stopped for at least 7 days before the screening period.If you intend to continue drug therapy during the study period, you should keep the same usage and dosage or stop the drug after evaluation by the doctor; (8) Participants volunteered to participate in this clinical study and signed written informed consent before the study began; (9) After the test treatment, permanent sacral nerve stimulator implantation is feasible if any of the following conditions are met: 1) The average daily frequency of urination in 3 days at the end of experiential treatment was reduced by >= 50% from baseline; 2) The average urination score at the end of 3 days of experiential therapy was reduced by >= 50% from baseline; 3) The frequency of urinary incontinence in 3 days at the end of experiential treatment was reduced by >= 50% from baseline; 4) At the end of 3 days of experiential treatment, the average volume of each urination increased by >= 50% from baseline; 5) The patient requested permanent implantation due to improvement in intestinal and sexual symptoms, the researchers evaluated the patient for permanent implant treatment.
Exclusion criteria
Exclusion criteria: (1) Other causes of lower urinary tract dysfunction cannot be ruled out, or other diseases that may lead to dysfunction of the lower urinary tract; (2) Pregnant women, lactating women, women of childbearing age who planned to get pregnant during the study period or who did not have safe contraceptives; (3) Patients with mental and cognitive impairment, and unable to cooperate with the trial; (4) Patients with uncured infections, coagulation disorders, malignant tumors and other serious diseases; (5) Those who had received other related surgical treatment (including but not limited to botulinum toxin type A ) or participated in other clinical trials within 3 months prior to enrollment; (6) Other conditions considered inappropriate by the investigator to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder compliance;maximum cystometric capacity; | — |
Secondary
| Measure | Time frame |
|---|---|
| NBSS score;SCI-QoL score;Micturition frequency;urgency;Urinary incontinence; | — |
Countries
China
Contacts
Public ContactYan Li
Qilu Hospital of Shandong University
Outcome results
None listed