Randomized Controlled, Open Clinical Study on Efficacy and Safety of Acupuncture for Bladder Function Recovery After Radical Cervical Cancer Surgery

NCT06095882 | Unknown

• 1 other identifier: KYLL-202309-002
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Urinary retention is one of the most common complications of radical hysterectomy in patients with cervical cancer, with an incidence of 26-53% depending on the diagnostic criteria. The most common method to prevent urinary retention after radical hysterectomy is continuous catheterization, but up to 14.5% of patients need continuous catheterization for more than 4 weeks, because catheterization is an invasive procedure, increasing the risk of urinary tract infection, and long-term postoperative retention of urinary catheter caused by edema of the vesicourethral sphincter and urethral glands. Obstruction of bladder outlet caused by increased urethral outflow resistance may also lead to postoperative urinary retention, thus forming a vicious cycle and aggravating urinary retention. In our previous retrospective analysis, it was confirmed that acupuncture and moxibustion were effective in restoring bladder function after radical hysterectomy. Compared with the control group, the incidence of urinary retention in patients receiving acupuncture and moxibustion was reduced from 44.17% to 24.17%, and no serious adverse reactions occurred, and the patients had good tolerance. We plan to conduct further randomized controlled studies to confirm this.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• The incidence of urinary retention

  The urinary tube was removed 14 days after operation and the residual urine volume was measured

  1year

Study Arms (2)

acupuncture

EXPERIMENTAL

Other: acupuncture

observe

NO INTERVENTION

Interventions

acupuncture OTHER

Study group: Acupuncture treatment was performed from day 3 to day 14 after surgery. Points include: Zhongwan, Tianshu, Watercourse, Taichong, Sanyinjiao, Zusanli, Yin Lingquan. Control group: No intervention, the urinary tube was removed until the 14th day after surgery. Patients with urinary retention may receive further acupuncture treatment.

acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; (2) Female, ≥18 years of age (calculated on the date of signing the informed consent); (3) Pathological diagnosis of cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma, preoperative cervical lesions ≤4cm; (4) No history of urinary system infection and urinary retention; (5) Undergoing radical abdominal hysterectomy; (6) On the third day after surgery, vital signs were stable, no discomfort symptoms (such as abnormal abdominal distension, nausea, vomiting, abdominal pain, chest tightness, etc.) of CTCAE 5.0 standard 2 or above, and no abnormal increase in body temperature (≥38.5°C); (7) The function of vital organs meets the following requirements: Absolute neutrophil count ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥80g/L; Serum albumin ≥2.5g/dL; Bilirubin ≤1.5 ULN; ALT and AST≤3 times ULN; Serum creatinine ≤1.5 ULN; INR≤1.5 or prothrombin time ≤ULN+4 seconds.

You may not qualify if:

• Suffering from diseases that may affect bladder function, such as uterine prolapse, vaginal wall bulge, lower urinary tract obstruction, bladder tumor, urethral injury, urinary tract stones, urinary tract infection, spinal cord injury, and sequelae of cardiovascular and cerebrovascular diseases;
• Poor compliance and failure to strictly carry out full treatment;
• Use of neostigmine and other drugs that affect bladder function;
• Patients with serious diseases of important organs and mental diseases;
• There were random postoperative discomfort symptoms with the severity reaching CTCAE 5.0 level 2 or above;
• There is an active infection or prerandom unexplained fever ≥38.5°C;
• Patients with clinical symptoms or diseases of heart that are not well controlled, such as: NYHA2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
• diabetic patients;
• In the judgment of the investigator, the subjects have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental illness) requiring combined treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of the subjects or the collection of data.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Hualei Bu

CONTACT

buhualei@email.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: November 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-09