Postoperative Urinary Retention (POUR)NCT07235371
Transcutaneous Electrical Acupoint Stimulation for Postoperative Urinary Retention After Radical Surgery for Cervical Cancer
A study testing transcutaneous electrical acupoint stimulation in people with Postoperative Urinary Retention (POUR), run by Lu Chao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Urinary Retention (POUR)
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Chao Lu, 15869128904, luchao@zjcc.org.cn
About this study
Official title: Transcutaneous Electrical Acupoint Stimulation on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer: A Randomized Controlled 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.
- Conditions
- Postoperative Urinary Retention (POUR)
- Being tested
- transcutaneous electrical acupoint stimulation, Sham transcutaneous electrical acupoint stimulation
- Keywords
- Postoperative urinary retention,, POUR, TEAS, transcutaneous electrical acupoint stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationOther
Also called TEAS
Participants 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 stimulationOther
Also called Sham TEAS
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| The TEAS Group | Experimental | Participants 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. Receives: Other: transcutaneous electrical acupoint stimulation |
| The Sham TEAS Group | Placebo comparator | Participants will receive sham TEAS treatment once a day for two consecutive weeks. The operation of the sham TEA group will be consistent with that of the TEAS group, with a current intensity set to 30mA. 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. Receives: Other: Sham transcutaneous electrical acupoint stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 2 (after intervention), and week 4 （follow-up）
Secondary outcomes (4)
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.
Measured: week 2 （after intervention）
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.
Measured: Week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
The evaluation of the quality of life
Assessing patients' quality of life using the EQRTC QLQ-C30 scale.
Measured: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
Safety Assessment
Evaluate based on the Adverse Event Scale.
Measured: week 2 （after intervention）, and week 4 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start18 Nov 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Urinary Retention (POUR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu Chao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Chao, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235371
- Sponsor's protocol ID
- IRB-2025-1262
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07235371
- Acronym / sponsor ID
- IRB-2025-1262
- Conditions
- Postoperative Urinary Retention (POUR)
- Keywords
- Postoperative urinary retention,, POUR, TEAS, transcutaneous electrical acupoint stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Lu ChaoUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The TEAS Group | Experimental | Other: transcutaneous 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. |
| The Sham TEAS Group | Placebo comparator | Other: Sham transcutaneous electrical acupoint stimulationParticipants will receive sham TEAS treatment once a day for two consecutive weeks. The operation of the sham TEA group will be consistent with that of the TEAS group, with a current intensity set to 30mA. 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical acupoint stimulationAlso: TEASParticipants 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. | Other | The TEAS Group |
| Sham transcutaneous electrical acupoint stimulationAlso: Sham TEASParticipants 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. | Other | The Sham TEAS Group |
Primary outcome
The change in post-void residual (PVR) volume of the bladder
Time frame: week 2 (after intervention), and week 4 （follow-up）
It will use a direct measurement method to detect residual urine volume in the bladder.
4 secondary outcomes
The response rate of participants who will successfully remove the urinary catheter
Time frame: week 2 （after intervention）
The proportion of patients who have a urinary tract infection (UTI).
Time frame: Week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
The evaluation of the quality of life
Time frame: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
Safety Assessment
Time frame: week 2 （after intervention）, and week 4 (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation in people with Postoperative Urinary Retention (POUR), run by Lu Chao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Lu (15869128904, luchao@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in post-void residual (PVR) volume of the bladder (time frame: week 2 (after intervention), and week 4 （follow-up）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.