Lower urinary tract dysfunction with hydronephrosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. SACRAL neuromodulation surgery or voluntary sacral neuromodulation surgery; 2. Neurogenic lower urinary tract dysfunction was diagnosed and the nervous system lesions were stable (3-6 months) ; 3. Double hydronephrosis was suggested by imaging examination; 4. Intermittent urinary Catheterization (CIC) could be performed by oneself or with nursing care; 5. ECOG Physical Condition: 0 Or 1; 6. Refuse BTX-A injection or bladder enlargement; 7. Agree to take the drug as directed during the trial; 8. Volunteer to participate in the clinical study with informed consent; 9. Be able to communicate well with the researchers and be willing to comply with the requirements of the entire study.
Exclusion criteria
Exclusion criteria: 1. Complete Paraplegia or with Severe Progressive Neuropathy; 2. Abnormal Autonomic Reflex; 3. Severe upper urinary tract injury with Renal Insufficiency requiring dialysis; 4. Severe Cardiac and hepatic impairment; 5. Pregnant, lactating women, women of childbearing age who planned pregnancy or did not have safe contraceptive methods during the study period; 6. Accompanied with uncontrolled urinary tract infection, urinary tract obstruction, tumor and other serious health-related diseases; 7. Mental and cognitive disorders that prevented the completion of the study; 8. Having coagulation disorders or requiring anticoagulant therapy and not being able to suspend treatment; 9. Any serious complication or disease that may prevent the subject from participating in or increase his or her risk of undergoing surgery; 10. A history of treatment or history of a traumatic injury to the genitourinary system that may affect the baseline physiology of the bladder, such as partial pelvic radiotherapy and chemotherapy, bladder surgery, and bladder cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urodynamic examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative blood routine, biochemical, urine test, local conditions of operation;Results of ultrasound examination of urinary system;Urination diary at each follow-up time point;Lower urinary tract symptoms and quality of life score; | — |
Countries
China
Contacts
Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University