NCT06639399

Brief Summary

This is a retrospective cohort study using a paired control design. We will review the patients of PUR after cervical cancer surgery who went to the acupuncture department and the urinary retention department in Zhejiang Cancer Hospital from October 2020 to August 2024, and 73 patients met the screening criteria. All patients provided written informed consent. The purpose of the study is to compare the effect of acupuncture at different combinations of acupoints for postoperative urinary retention (PUR) after radical hysterectomy of cervical cancer. All outcome-measures data were obtained from past medical records. It is an observational study rather than an intervention study. 73 patients met the screening criteria. They will be assigned into two groups according to the treatment scheme of acupoints combination for acupuncture: Group A (37 cases) and Group B (36 cases).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

October 9, 2024

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The change value in residual urine volume

    Residual urine volume was assessed before the first treatment and after the final treatment by a trained outpatient nurse using a direct measurement method involving catheter insertion for urine drainage and measurement. Calculate the difference value in residual urine volume before and after treatment.

    baseline and 2 weeks

Secondary Outcomes (3)

  • The patient's abdominal distension sensation by the visual analog scale (VAS) method

    baseline and 2 weeks

  • The occurrence of urinary tract infections

    baseline and 2 weeks

  • The total effective rate

    2 weeks

Study Arms (2)

Group A

Patients received acupuncture treatment at the lumbosacral region, all acupoints belong to the bladder meridian, including Shenshu (BL23), Pangguangshu (BL28), Ciliao (BL32), Huiyang (BL35), and Zhibian (BL54) selected bilaterally.

Other: Acupuncture

Group B

Patients received acupuncture treatment using a comprehensive acupoint combination scheme. In addition to the acupoints used in Group A, the following acupoints were added: Qihai (RN6), Guanyuan (RN4), Zhongji (RN3), Shuidao (ST28), Yinglingquan (S9), and Sanyinjiao (SP6).

Other: Acupuncture

Interventions

Patients received acupuncture treatment at the lumbosacral region, all acupoints belong to the bladder meridian, including Shenshu (BL23), Pangguangshu (BL28), Ciliao (BL32), Huiyang (BL35), and Zhibian (BL54) selected bilaterally. Electroacupuncture (EA) was applied to the BL32 and BL54 acupoints at a frequency of 2/100Hz. Each treatment lasting for 30 minutes. Patients received five acupuncture treatments per week for two consecutive weeks

Also known as: Electroacupuncture
Group A

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients of postoperative urinary retention after radical hysterectomy of cervical cancer

You may qualify if:

  • years old
  • Karnofsky Performance Scale (KPS) score \> 70
  • met the diagnostic criteria of PUR
  • no history of serious urinary system diseases or urinary retention before the operation
  • had clear cognition and no severe mental diseases
  • had complete medical records and records of residual urine volume data.

You may not qualify if:

  • presence of other serious systemic diseases or advanced cachexia
  • obstructive urinary retention caused by urethral stricture, stones, or other diseases
  • receiving other treatments or self-change treatment
  • poor compliance or failure to complete the acupuncture treatments
  • incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Interventions

Acupuncture TherapyElectroacupuncture

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

December 1, 2024

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations