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
This trial does not accept healthy volunteersQualifiers
(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
Design model
Parallel
Treatments tested in this trial
transcutaneous electrical acupoint stimulation
Other interventionParticipants 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.
Sham transcutaneous electrical acupoint stimulation
Other interventionParticipants 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: The TEAS GroupExperimental treatment 1 intervention
Group B: The Sham TEAS GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change in post-void residual (PVR) volume of the bladder
It will use a direct measurement method to detect residual urine volume in the bladder.
Time frame
week 2 (after intervention), and week 4 （follow-up）Secondary outcomes
1
The response rate of participants who will successfully remove the urinary catheter
The participants in each group who will remove their urinary catheters after intervention (week 2), in proportion to the total number of patients in each group, multiplied by 100%. It can also be understood as the initial cure rate of POUR.
Time frame
week 2 （after intervention）2
The proportion of patients who have a urinary tract infection (UTI).
Determine whether the patient has a urinary tract infection based on their urine routine test or urine culture test results.
Time frame
Week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）3
The evaluation of the quality of life
Assessing patients' quality of life using the EQRTC QLQ-C30 scale.
Time frame
week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）4
Safety Assessment
Evaluate based on the Adverse Event Scale.
Time frame
week 2 （after intervention）, and week 4 (follow-up)Other outcomes
1
Participant Expectation Value Evaluation
Evaluate based on the participant's expected value scale
Time frame
week 0 (baseline)2
Blinding evaluation
Evaluate according to the established blind assessment questionnaire
Time frame
week 2（after intervention）3
Participant compliance assessment
Evaluate based on the participant compliance assessment scale
Time frame
week 2 （after intervention）and week 4（follow-up）Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lu Chao
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov