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Transcutaneous tibial nerve stimulation versus sham stimulation for the treatment of catheter-related bladder discomfort in patients undergoing transurethral resection of the prostate: a prospective, randomized, placebo-controlled, double-blind trial

Transcutaneous tibial nerve stimulation versus sham stimulation for the treatment of catheter-related bladder discomfort in patients undergoing transurethral resection of the prostate: a prospective, randomized, placebo-controlled, double-blind trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088488
Enrollment
Unknown
Registered
2024-08-20
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-08-18

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:Transcutaneous tibial nerve stimulation
Sham:sham intervention

Sponsors

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

Eligibility

Sex/Gender
Male
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing transurethral resection of the prostate (TURP) under general anesthesia with postoperative catheterization, self-reporting symptoms indicative of Catheter-Related Bladder Discomfort (CRBD). 2. Age within the range of 18 to 74 years, classified as American Society of Anesthesiologists (ASA) Class I-II. 3. Cognitively intact individuals capable of coherent communication, providing detailed descriptions of their symptoms and successfully completing the requisite assessments. 4. Voluntary consent to participate in the study, demonstrated through the informed and documented agreement by signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects equipped with cardiac pacemakers or implanted defibrillators. 2. Individuals exhibiting contraindications to electrical stimulation, cutaneous hypersensitivity, dermal lesions, or localized infections at the stimulation site. 3. Participants with a documented history of prior transcutaneous tibial nerve stimulation device usage. 4. Patients presenting with additional urological pathologies potentially confounding study outcomes, including conditions such as Overactive Bladder (OAB). 5. Patients diagnosed with psychiatric disorders, like schizophrenia depression, or cognitive impairments, rendering them unable to actively participate in the study. 6. Individuals under prolonged administration of opioid analgesics.

Design outcomes

Primary

MeasureTime frame
the NRS score quantifying the severity of CRBD discomfort at intervention completion;

Secondary

MeasureTime frame
NRS scores for CRBD discomfort at 1, 2, and 6 hours post-intervention;NRS scores for postoperative pain at 0, 1, 2, and 6 hours post-intervention;postoperative analgesic utilization (quantified within 6 hours post-treatment for tramadol and sufentanil);patient satisfaction scores (assessed on a 7-point Likert scale at 6 hours post-intervention, ranging from 1 for "very dissatisfied" to 7 for "very satisfied"); the incidence of postoperative delirium evaluated within 6 hours using the Chinese version of the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM).;

Countries

China

Contacts

Public ContactWang Yongqiang

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

saint517@shutcm.edu.cn+86 137 6443 3884

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 30, 2026