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Study on the effectiveness and safety of sacral nerve regulation in patients with neurogenic lower urinary tract dysfunction and hydronephrosis

Study on the effectiveness and safety of sacral nerve regulation in patients with neurogenic lower urinary tract dysfunction and hydronephrosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046839
Enrollment
Unknown
Registered
2021-05-29
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower urinary tract dysfunction with hydronephrosis

Interventions

experimental group:The patients in the observation group received routine treatment and nursing care
control group:The patients were followed up 3, 6, 9, 12, 18 and 24 months after the group, including strict intermittent catheterization, drug therapy and regular reexamination

Sponsors

Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Urodynamic examination;

Secondary

MeasureTime 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

Public ContactHuang Hai

Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University

huanghai257@126.com+86 13711502580

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026