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Percutaneous tibial nerve stimulation for prevention of catheter-related bladder discomfort after transurethral ureteroscopic lithotripsy: a prospective, randomised, double-blind, placebo-controlled trial

Percutaneous tibial nerve stimulation for prevention of catheter-related bladder discomfort after transurethral ureteroscopic lithotripsy: a prospective, randomised, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086924
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-07-20
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

catheter-related bladder discomfort

Interventions

TTNS group:A TTNS stimulator will be worn longitudinally above the inner ankle on the patients medial calf, and the tibial nerve was stimulated at an intensity slightly below motor threshold for 30 mi
False stimulus group:Wearing only the TTNS stimulator without electrical stimulation, using a physical vibration device to make the patient feel a vibration sensation in the legs.

Sponsors

Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: (1) Male patients undergoing elective transurethral ureteroscopic lithotripsy under general anaesthesia who meet the criteria for the procedure as assessed by the surgeon; (2) Requires an indwelling urinary catheter postoperatively; (3) Age 18-79 years old, ASA (American Society of Anaesthesiologists) classification I-II; (4) The patient was conscious and able to answer questions, describe his/her symptoms and complete the assessment; (5) Agreed and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients wearing pacemakers or implantable defibrillators; (2) Patients with contraindications to electrical stimulation, skin allergies at the site of stimulation, broken skin, or infection; (3) Patients who have ever used a percutaneous tibial nerve stimulator; (4) Those with other urological conditions that may have an impact on study results. For example, patients with overactive bladder (OAB), patients with prostatic hyperplasia, etc; (5) Patients with psychiatric system disorders (e.g., schizophrenia, depression, etc.) or cognitive dysfunction that precludes co-operation; (6) Long-term use of opioid analgesics;

Design outcomes

Primary

MeasureTime frame
Incidence of more than moderate CRBD;

Secondary

MeasureTime frame
Incidence of more than moderate CRBD;Postoperative pain VAS score;Demand for analgesic drugs within 6 hours ;Satisfaction;Incidence of awakening agitation;Incidence of postoperative delirium;

Countries

China

Contacts

Public ContactWang yongqiang

Department of Anesthesia, Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine

173430064@qq.com+86 137 6443 3884

Outcome results

None listed

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