Postoperative Urinary Retention (POUR)APOURNCT07711977
Efficacy of Acupuncture for Postoperative Urinary Retention Following Radical Hysterectomy for Cervical Cancer
A study testing Acupuncture in people with Postoperative Urinary Retention (POUR), run by Obstetrics & Gynecology Hospital of Fudan University.
Trial summary
The goal of this clinical trial is to learn if acupuncture works to treat postoperative urinary retention in patients who have undergone radical hysterectomy for cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Urinary Retention (POUR)
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- Jul 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a pathologically confirmed diagnosis of cervical cancer who have undergone radical hysterectomy for cervical cancer.
- Patients who developed urinary retention after catheter removal during routine postoperative follow-up (2-4 weeks after surgery), with post-void residual urine volume measured by ultrasound exceeding 100 ml on two consecutive occasions.
- Aged ≥18 years.
- Patients who are informed and voluntarily sign the informed consent form.
- Patients with a Karnofsky Performance Status (KPS) score ≥70 .
Who cannot join
- Patients with a clear preoperative diagnosis of urinary retention or voiding dysfunction.
- Patients with urinary retention caused by conditions other than radical surgery for cervical cancer, such as spinal cord injury or other diseases.
- Patients with severe heart, lung, or kidney failure, or those with severe medical comorbidities.
- Patients with a severe bleeding tendency due to any cause.
- Patients with severe consciousness disorders or psychiatric/psychological conditions that preclude cooperation with treatment.
About this study
Official title: Evaluation of the Efficacy of Acupuncture Combined With Intermittent Catheterization for Postoperative Urinary Retention Due to Neurogenic Bladder Following Radical Hysterectomy for Cervical Cancer
The goal of this clinical trial is to learn if acupuncture works to treat postoperative urinary retention in patients who have undergone radical hysterectomy for cervical cancer. The main question it aims to answer is:
Does acupuncture lower the volume of post-void residual in participants who need to use intermittent catheterization to assist with voiding after radical hysterectomy for cervical cancer?
Read more
Researchers will compare acupuncture to sham acupuncture (non-penetrating needles: using placebo needles with a blunt tip that gives the sensation of skin penetration without actually piercing the skin) to see if acupuncture works to treat postoperative urinary retention.
Participants will:
- Receive acupuncture or sham acupuncture or tamsulosin for 2 weeks.
- Visit the clinic before and after treatment for checkups and tests.
- Keep a voiding diary and record the volume of post-void residual and the number of times they use intermittent catheterization.
- Conditions
- Postoperative Urinary Retention (POUR)
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- acupuncture, radical hysterectomy, postoperative urinary retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Participants receive acupuncture treatment in addition to intermittent catheterization and an α-blocker (e.g., tamsulosin). Acupoints selected: Zhongji (CV3), Yinlingquan (SP9), Sanyinjiao (SP6), Ciliao (BL32), Zhongliao (BL33), Pangguangshu (BL28), Zhibian (BL54). Treatment lasts for 2 weeks.
Sham acupunctureProcedure or surgery
Participants receive sham acupuncture treatment in addition to intermittent catheterization and an α-blocker (e.g., tamsulosin). The same acupoints as in the acupuncture group are selected. Sham acupuncture method: using a placebo needle device with a blunt tip that gives the sensation of skin penetration without actually piercing the skin. Treatment lasts for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Procedure: Acupuncture |
| Sham acupuncture | Placebo comparator | Not described Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-void residual urine volume (PVR)
Measured via B-mode ultrasound after spontaneous voiding following catheter removal and ingestion of approximately 1000 ml of water.
Measured: pre-intervention，immediately after the intervention
Secondary outcomes (4)
Voiding diary
Standardized recording of urinary frequency, volume, and symptom patterns over a defined period.
Measured: pre-intervention，immediately after the intervention
Maximum urinary flow rate (Qmax)
Peak flow rate during voiding, obtained via urodynamic assessment.
Measured: pre-intervention，immediately after the intervention
First desire to void (FDV)
Volume of urine in the bladder at the initial sensation of needing to urinate, obtained via urodynamic assessment.
Measured: pre-intervention，immediately after the intervention
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form
International Consultation on Incontinence Questionnaire for Female Lower Urinary Tract Symptoms (long form), used to quantify symptom burden and quality of life impact. The minimum value of the questionnaire is 0 and the maximum value is 69. Higher scores mean a worse outcome.
Measured: pre-intervention，immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion30 Jun 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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, RenJi Hospital, Jiaxing Maternity and Child Health Care Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711977
- Sponsor's protocol ID
- FUOBGY-2025-200
- Other IDs
- 2025YFC3508302
- Acronym
- APOUR
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Acupuncture Combined With Intermittent Catheterization for Postoperative Urinary Retention Due to Neurogenic Bladder Following Radical Hysterectomy for Cervical Cancer
- ClinicalTrials.gov ID
- NCT07711977
- Acronym / sponsor ID
- APOUR / FUOBGY-2025-200
- Conditions
- Postoperative Urinary Retention (POUR)
- Keywords
- acupuncture, radical hysterectomy, postoperative urinary retention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Fudan University, RenJi Hospital, Jiaxing Maternity and Child Health Care Hospital
- Study start
- Jul 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jul 2026 (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.
The goal of this clinical trial is to learn if acupuncture works to treat postoperative urinary retention in patients who have undergone radical hysterectomy for cervical cancer. The main question it aims to answer is:
Does acupuncture lower the volume of post-void residual in participants who need to use intermittent catheterization to assist with voiding after radical hysterectomy for cervical cancer?
Researchers will compare acupuncture to sham acupuncture (non-penetrating needles: using placebo needles with a blunt tip that gives the sensation of skin penetration without actually piercing the skin) to see if acupuncture works to treat postoperative urinary retention.
Participants will:
- Receive acupuncture or sham acupuncture or tamsulosin for 2 weeks.
- Visit the clinic before and after treatment for checkups and tests.
- Keep a voiding diary and record the volume of post-void residual and the number of times they use intermittent catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: Acupuncture |
| Sham acupuncture | Placebo comparator | Procedure: Sham acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a pathologically confirmed diagnosis of cervical cancer who have undergone radical hysterectomy for cervical cancer.
- Patients who developed urinary retention after catheter removal during routine postoperative follow-up (2-4 weeks after surgery), with post-void residual urine volume measured by ultrasound exceeding 100 ml on two consecutive occasions.
- Aged ≥18 years.
- Patients who are informed and voluntarily sign the informed consent form.
- Patients with a Karnofsky Performance Status (KPS) score ≥70 .
Key exclusion criteria (5 listed)
- Patients with a clear preoperative diagnosis of urinary retention or voiding dysfunction.
- Patients with urinary retention caused by conditions other than radical surgery for cervical cancer, such as spinal cord injury or other diseases.
- Patients with severe heart, lung, or kidney failure, or those with severe medical comorbidities.
- Patients with a severe bleeding tendency due to any cause.
- Patients with severe consciousness disorders or psychiatric/psychological conditions that preclude cooperation with treatment.
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 |
|---|---|---|
| AcupunctureParticipants receive acupuncture treatment in addition to intermittent catheterization and an α-blocker (e.g., tamsulosin). Acupoints selected: Zhongji (CV3), Yinlingquan (SP9), Sanyinjiao (SP6), Ciliao (BL32), Zhongliao (BL33), Pangguangshu (BL28), Zhibian (BL54). Treatment lasts for 2 weeks. | Procedure or surgery | Acupuncture |
| Sham acupunctureParticipants receive sham acupuncture treatment in addition to intermittent catheterization and an α-blocker (e.g., tamsulosin). The same acupoints as in the acupuncture group are selected. Sham acupuncture method: using a placebo needle device with a blunt tip that gives the sensation of skin penetration without actually piercing the skin. Treatment lasts for 2 weeks. | Procedure or surgery | Sham acupuncture |
Primary outcome
Post-void residual urine volume (PVR)
Time frame: pre-intervention，immediately after the intervention
Measured via B-mode ultrasound after spontaneous voiding following catheter removal and ingestion of approximately 1000 ml of water.
4 secondary outcomes
Voiding diary
Time frame: pre-intervention，immediately after the intervention
Maximum urinary flow rate (Qmax)
Time frame: pre-intervention，immediately after the intervention
First desire to void (FDV)
Time frame: pre-intervention，immediately after the intervention
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form
Time frame: pre-intervention，immediately after the intervention
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 17 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Postoperative Urinary Retention (POUR), run by Obstetrics & Gynecology Hospital of Fudan University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-void residual urine volume (PVR) (time frame: pre-intervention，immediately after the intervention). 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 17 Jul 2026.