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

16. juli 2026 opdateret af: Obstetrics & Gynecology Hospital of Fudan University

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?

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

324

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Akupunktur
Procedure: Acupuncture
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.
Placebo komparator: Sham akupunktur
Procedure: Sham 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-void residual urine volume (PVR)
Tidsramme: 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.
pre-intervention，immediately after the intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Voiding diary
Tidsramme: pre-intervention，immediately after the intervention
Standardized recording of urinary frequency, volume, and symptom patterns over a defined period.
pre-intervention，immediately after the intervention
Maximum urinary flow rate (Qmax)
Tidsramme: pre-intervention，immediately after the intervention
Peak flow rate during voiding, obtained via urodynamic assessment.
pre-intervention，immediately after the intervention
First desire to void (FDV)
Tidsramme: pre-intervention，immediately after the intervention
Volume of urine in the bladder at the initial sensation of needing to urinate, obtained via urodynamic assessment.
pre-intervention，immediately after the intervention
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form
Tidsramme: pre-intervention，immediately after the intervention
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.
pre-intervention，immediately after the intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Samarbejdspartnere

Fudan University
RenJi Hospital
Jiaxing Maternity and Child Health Care Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. juni 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FUOBGY-2025-200
  • 2025YFC3508302 (Andet bevillings-/finansieringsnummer: National Key Research and Development Program of China)

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Postoperativ urinretention (POUR)

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