Transcutaneous Electrical Acupoint Stimulation for Postoperative Urinary Retention After Radical Surgery for Cervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorLu Chao
About this trial
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.
Eligibility criteria
Qualifiers
(1) Age range of 18-70 years, expected survival period ≥ 6 months; (2) Meets diagnostic criteria, with an indwelling catheter duration of more than 14 days but less than 1 year; (3) No history of urinary system diseases before surgery; (4) Clear consciousness, unobstructed communication, daily living ability, patients or family members can learn TEAS operation; (5) No serious systemic diseases such as heart, liver, brain, kidney, etc; (6) Karnofsky functional status score (KPS) ≥ 70 points; (7) Voluntarily participate and sign a written informed consent form.
Disqualifiers
(1) Obstructive urinary retention, such as urethral stricture or stones; (2) combined with other serious systemic diseases, advanced cachexia; (3) Patients with pacemaker implantation or metal implantation in the body; (4) The treatment site has skin lesions or is not suitable for TEAS treatment in other populations; (5) Physical or mental disorders with cognitive impairment; (6) Other clinical trial participants who are currently involved in affecting the results of this study; (7) Those who do not agree to participate in clinical trials; (8) The evaluator has determined that the participant is not suitable to participate in this study.
Trial design
Treatments tested in this trial
- transcutaneous electrical acupoint stimulation
- Sham transcutaneous electrical acupoint stimulation
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lu Chao
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov