NCT07711977

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

June 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 10, 2026

Last Update Submit

July 16, 2026

Conditions

Postoperative Urinary Retention (POUR)

Keywords

acupunctureradical hysterectomypostoperative urinary retention

Outcome Measures

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.

    pre-intervention，immediately after the intervention

Secondary Outcomes (4)

  • Voiding diary

    pre-intervention，immediately after the intervention

  • Maximum urinary flow rate (Qmax)

    pre-intervention，immediately after the intervention

  • First desire to void (FDV)

    pre-intervention，immediately after the intervention

  • International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form

    pre-intervention，immediately after the intervention

Study Arms (2)

Acupuncture

EXPERIMENTAL
Procedure: Acupuncture

Sham acupuncture

PLACEBO COMPARATOR
Procedure: Sham acupuncture

Interventions

AcupuncturePROCEDURE

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.

Acupuncture
Sham acupuncturePROCEDURE

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.

Sham acupuncture

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

July 17, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share