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RecruitingNCT07235371

Transcutaneous Electrical Acupoint Stimulation for Postoperative Urinary Retention After Radical Surgery for Cervical Cancer

Transcutaneous Electrical Acupoint Stimulation on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer: A Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
76 (estimated)
Sponsor
Lu Chao · Academic / Other
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This is a prospective, blinded, single-center, randomized controlled trial. We will include 76 patients with postoperative urinary retention (POUR) after radical hysterectomy for cervical cancer who have a clear diagnosis and meet the screening criteria as the research object. They will be randomly divided into the transcutaneous electrical acupoint stimulation(TEAS)group and the sham TEAS group according to a 1:1 ratio. Each group consists of 38 patients, and all patients will be required to sign a written informed consent form. The TEAS group will be treated with TEAS based on conventional treatment, and the sham TEAS group will be treated with shamTEAS based on conventional treatment. The main outcomes will be the changes in post-void residual (PVR) volume; secondary indicators will include the response rate of participants with successful urinary catheter removal after intervention, assessment of urinary tract infection (UTI), and patient quality of life assessment according to the EORTC QLQ-C30 scale. The participants will also be evaluated with expectations, blind evaluation, compliance evaluation, and safety evaluation to preliminarily evaluate the effect of TEAS for postoperative urinary retention after radical hysterectomy for cervical cancer.

Conditions

Interventions

TypeNameDescription
OTHERtranscutaneous electrical acupoint stimulationParticipants will receive TEAS treatment once a day for two consecutive weeks. TEAS stimulation: A set of TEAS patch stimulation will be applied to BL32 and BL34 points on both sides of the spine respectively, with an intensity of approximately 30 ± 5mA, based on patient tolerance. The frequency will be 2/10Hz.
OTHERSham transcutaneous electrical acupoint stimulationParticipants will receive sham TEAS treatment once a day for two consecutive weeks. The operation of the sham TEAS group will be consistent with that of the TEAS group, with a current intensity set at 30 mA. However, the instrument circuit of the fake TEAS group cannot output current normally, and participants can only feel patches stimulating at the BL32 and BL34 acupoints.

Timeline

Start date
2025-11-18
Primary completion
2028-11-30
Completion
2028-11-30
First posted
2025-11-19
Last updated
2026-02-06

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07235371. Inclusion in this directory is not an endorsement.