Postoperative Urinary Retention (POUR)NCT07253194
Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer
A study testing EA intervention 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. Investigators will include 208 patients with postoperative urinary retention (POUR) after radical hysterectomy for cervical cancer who have a clear diagnosis and meet the screening criteria. 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?
- EA intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 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 18 to 70 years old;
- ② Anticipated survival of at least 6 months;
- ③ Met the diagnostic criteria for POUR of cervical cancer, and the duration of POUR is less than 6 months;
- ④ No serious urinary system disease in the past, and no urinary retention before operation;
- ⑤ Karnofsky functional status score (KPS) ≥ 70 points;
- ⑥ Stable vital signs, no serious mental illness, capable of daily living, able to cooperate in completing all treatments and examinations;
- ⑦ Voluntarily participate and sign a written informed consent form.
Who cannot join
- ① Obstructive urinary retention, such as urethral stricture or stones induced urinary system diseases;
- ② Merge other serious systemic diseases, and advanced cachexia patients;
- ③ Patients who are intolerant to electrical stimulation therapy, such as those with pacemakers installed;
- ④ With psychiatric disorder or severe cognitive impairment;
- ⑤ Severe skin damage, infection, and ulceration at the treatment site;
- ⑥ Those who are participating in other acupuncture or drug clinical trials.
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: Effect of Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer： A Randomized Controlled Trial
This is a prospective, blinded, single-center, randomized controlled trial. Investigators will include 208 patients with postoperative urinary retention (POUR) after radical hysterectomy for cervical cancer who have a clear diagnosis and meet the screening criteria. Participants will be randomly divided into the electroacupuncture（EA）group and the sham EA group according to a 1:1 ratio. Each group consists of 104 patients, and all participants will be required to sign a written informed consent form. The TEAS group will be treated with EA based on conventional treatment, and the shamEA group will be treated with sham EA based on conventional treatment. The main outcomes will be to calculate the proportion of patients who successfully removed the urinary catheter, and the secondary indicators will include the change in post-void residual (PVR) volume of the bladder, assessment of urinary tract infection (UTI), and quality of life assessment according to the EORTC QLQ-C30 scale. Evaluation of participant-reported expectations, blinding, compliance, and safety will also be conducted. All analyses will be conducted in accordance with the intention-to-treat principle.
- Conditions
- Postoperative Urinary Retention (POUR)
- Being tested
- EA intervention, Sham EA intervention
- Keywords
- Postoperative urinary retention, POUR, Electroacupuncture, EA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA interventionOther
Participants will undergo EA treatment. Acupoint selection: Shenshu(BL23), Pangguanghu (BL28), Ciliao (BL32), Zhongliao (BL33), Huiyang (BL35), and Zhibian (BL54). Acupuncture needles (0.30 × 50 mm) will be vertically inserted into BL32, BL23, BL28, and BL35 at a depth of 40 ± 8 mm. The disposable acupuncture needle (0.45 × 75 mm) will be inserted into BL54 at a depth of 55 ± 10 mm, with the direction of insertion toward Shuidao (ST28). EA will be applied to the BL32 and BL54 points on both sides of the spine at a frequency of 2 Hz and a stimulation intensity of 2 ± 1.5 mA. Each treatment will last for 30 minutes, 5 days per week, for 2 weeks. Follow-up will be performed 2 weeks after the final treatment.
Sham EA interventionOther
Participants will receive sham EA treatment. Acupoint selection: consistent with the EA group. Sham acupuncture procedure: The disposable acupuncture needle (0.25 × 40 mm) will be used, and all acupoints will be shallowly penetrated into the skin using a vertical method, with a needle depth of 5 ± 2 mm. Sham EA application: EA electrodes will be attached identically to the EA group at a frequency of 2 Hz and a nominal intensity of 2 mA. However, no electrical current will be delivered via the EA device, as the connecting wires will undergo specialized modification. Each treatment session will also last 30 minutes, 5 days per week, for 2 weeks. The Follow-up will also be performed 2 weeks after the final treatment.
| Study group | Role | What they receive |
|---|---|---|
| The EA Group | Experimental | Participants will receive the EA intervention for two consecutive weeks. Receives: Other: EA intervention |
| The sham EA Group | Sham comparator | Participants will receive the sham EA intervention for two consecutive weeks. Receives: Other: Sham EA intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, 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. The standard for patients to remove the urinary catheter is that the PVR volume is less than 100ml.
Measured: week 0（baseline），and week 2 (after intervention)
Secondary outcomes (3)
The changes in PVR volume.
It will be measured by professional nurses, using a direct measurement method.
Measured: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
Assessment of UTI.
Urinalysis or urine culture will be performed confirm the presence or absence of UTI.
Measured: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
Assessment of patient quality of life.
Patient quality of life according to the EORTC QLQ-C30 scale. Higher scores on the functional subscales indicate better quality of life, whereas higher scores on the symptom subscales reflect more severe symptoms.
Measured: week 0 (baseline), 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 posted28 Nov 2025
- Study start1 Jan 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 208 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
- NCT07253194
- Sponsor's protocol ID
- IRB-2025-1315
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu C, Chen N, Sun H, Wang C, Zhao L, Bao W, Deng D, Wang P, Li X. Effect of Electroacupuncture on Postoperative Urinary Retention After Radical Hysterectomy for Cervical Cancer: Study Protocol for A Randomized Controlled Trial. J Pain Res. 2026 Mar 18;19:598960. doi: 10.2147/JPR.S598960. eCollection 2026.
PubMed 41878088
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer： A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07253194
- Acronym / sponsor ID
- IRB-2025-1315
- Conditions
- Postoperative Urinary Retention (POUR)
- Keywords
- Postoperative urinary retention, POUR, Electroacupuncture, EA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Lu ChaoUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 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. Investigators will include 208 patients with postoperative urinary retention (POUR) after radical hysterectomy for cervical cancer who have a clear diagnosis and meet the screening criteria. Participants will be randomly divided into the electroacupuncture（EA）group and the sham EA group according to a 1:1 ratio. Each group consists of 104 patients, and all participants will be required to sign a written informed consent form. The TEAS group will be treated with EA based on conventional treatment, and the shamEA group will be treated with sham EA based on conventional treatment. The main outcomes will be to calculate the proportion of patients who successfully removed the urinary catheter, and the secondary indicators will include the change in post-void residual (PVR) volume of the bladder, assessment of urinary tract infection (UTI), and quality of life assessment according to the EORTC QLQ-C30 scale. Evaluation of participant-reported expectations, blinding, compliance, and safety will also be conducted. All analyses will be conducted in accordance with the intention-to-treat principle.
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 EA Group | Experimental | Other: EA interventionParticipants will receive the EA intervention for two consecutive weeks. |
| The sham EA Group | Sham comparator | Other: Sham EA interventionParticipants will receive the sham EA intervention for two consecutive weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ① 18 to 70 years old;
- ② Anticipated survival of at least 6 months;
- ③ Met the diagnostic criteria for POUR of cervical cancer, and the duration of POUR is less than 6 months;
- ④ No serious urinary system disease in the past, and no urinary retention before operation;
- ⑤ Karnofsky functional status score (KPS) ≥ 70 points;
Key exclusion criteria (6 listed)
- ① Obstructive urinary retention, such as urethral stricture or stones induced urinary system diseases;
- ② Merge other serious systemic diseases, and advanced cachexia patients;
- ③ Patients who are intolerant to electrical stimulation therapy, such as those with pacemakers installed;
- ④ With psychiatric disorder or severe cognitive impairment;
- ⑤ Severe skin damage, infection, and ulceration at the treatment site;
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 |
|---|---|---|
| EA interventionParticipants will undergo EA treatment. Acupoint selection: Shenshu(BL23), Pangguanghu (BL28), Ciliao (BL32), Zhongliao (BL33), Huiyang (BL35), and Zhibian (BL54). Acupuncture needles (0.30 × 50 mm) will be vertically inserted into BL32, BL23, BL28, and BL35 at a depth of 40 ± 8 mm. The disposable acupuncture needle (0.45 × 75 mm) will be inserted into BL54 at a depth of 55 ± 10 mm, with the direction of insertion toward Shuidao (ST28). EA will be applied to the BL32 and BL54 points on both sides of the spine at a frequency of 2 Hz and a stimulation intensity of 2 ± 1.5 mA. Each treatment will last for 30 minutes, 5 days per week, for 2 weeks. Follow-up will be performed 2 weeks after the final treatment. | Other | The EA Group |
| Sham EA interventionParticipants will receive sham EA treatment. Acupoint selection: consistent with the EA group. Sham acupuncture procedure: The disposable acupuncture needle (0.25 × 40 mm) will be used, and all acupoints will be shallowly penetrated into the skin using a vertical method, with a needle depth of 5 ± 2 mm. Sham EA application: EA electrodes will be attached identically to the EA group at a frequency of 2 Hz and a nominal intensity of 2 mA. However, no electrical current will be delivered via the EA device, as the connecting wires will undergo specialized modification. Each treatment session will also last 30 minutes, 5 days per week, for 2 weeks. The Follow-up will also be performed 2 weeks after the final treatment. | Other | The sham EA Group |
Primary outcome
The response rate of participants who will successfully remove the urinary catheter
Time frame: week 0（baseline），and week 2 (after intervention)
The participants in each group who will remove their urinary catheters after intervention, 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. The standard for patients to remove the urinary catheter is that the PVR volume is less than 100ml.
3 secondary outcomes
The changes in PVR volume.
Time frame: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
Assessment of UTI.
Time frame: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
Assessment of patient quality of life.
Time frame: week 0 (baseline), 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 2 Sep 2026.
- Derived from this study: PubMed 41878088Lu C, Chen N, Sun H, Wang C, Zhao L, Bao W, Deng D, Wang P, Li X. Effect of Electroacupuncture on Postoperative Urinary Retention After Radical Hysterectomy for Cervical Cancer: Study Protocol for A Randomized Controlled Trial. J Pain Res. 2026 Mar 18;19:598960. doi: 10.2147/JPR.S598960. eCollection 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 EA intervention 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 7 inclusion and 6 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 2 Sep 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, 1069103617@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate of participants who will successfully remove the urinary catheter (time frame: week 0（baseline），and week 2 (after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07253194, which also lists 1 linked publication.
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 2 Sep 2026.