CClinicalTrials.gg
Not yet recruitingNCT07711977APOURUpdated Jul 17, 2026

Efficacy of Acupuncture for Postoperative Urinary Retention Following Radical Hysterectomy for Cervical Cancer

An interventional study of Acupuncture and Sham acupuncture in Postoperative Urinary Retention (POUR), sponsored by Obstetrics & Gynecology Hospital of Fudan University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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:

  1. Receive acupuncture or sham acupuncture or tamsulosin for 2 weeks.
  2. Visit the clinic before and after treatment for checkups and tests.
  3. Keep a voiding diary and record the volume of post-void residual and the number of times they use intermittent catheterization.
02

Conditions studied

  • Postoperative Urinary Retention (POUR)

Keywords

  • acupuncture
  • radical hysterectomy
  • postoperative urinary retention
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
324 participants (estimated)

Study arms

  • Experimental
    Acupuncture

    Procedure: Acupuncture

  • Placebo comparator
    Sham acupuncture

    Procedure: Sham acupuncture

Interventions

  • ProcedureAcupuncture

    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.

  • ProcedureSham acupuncture

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: pre-intervention,immediately after the intervention

Secondary outcomes

  1. Voiding diary

    Standardized recording of urinary frequency, volume, and symptom patterns over a defined period.

    Time frame: pre-intervention,immediately after the intervention

  2. Maximum urinary flow rate (Qmax)

    Peak flow rate during voiding, obtained via urodynamic assessment.

    Time frame: pre-intervention,immediately after the intervention

  3. First desire to void (FDV)

    Volume of urine in the bladder at the initial sensation of needing to urinate, obtained via urodynamic assessment.

    Time frame: pre-intervention,immediately after the intervention

  4. 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.

    Time frame: pre-intervention,immediately after the intervention

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07711977
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborators
Fudan University, RenJi Hospital, Jiaxing Maternity and Child Health Care Hospital
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jul 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion