Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery

Overview

This study is to evaluate the effect of pelvic floor muscle electrophysiologic therapy on enhanced recovery after gynecologic surgery,to solve muscle soreness and retention of urine after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine adhesions.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2019

Detailed Description

Pelvic floor muscle electrophysiologic therapy is widely used in the treatment of pelvic floor dysfunction diseases at home and abroad. Electrical stimulation can also relieve depression and anxiety and play a sedative effect. In recent years, some studies have shown that pelvic floor electrophysiological therapy can improve the intimal blood flow resistance index of thin endometrium. Therefore, whether or not the pelvic floor electrophysiological therapy can relieve the muscle soreness caused by carbon dioxide retention after endoscopic surgery, reduce the postoperative urinary retention, shorten the postoperative anus exhaust time, and repair the endometrium after the intrauterine adhesion. we expect this electrophysiologic therapy can solve some common postoperative complications and difficult problems, such solve muscle soreness and retention of urine after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine adhesions. Hope to help patients recover quickly after surgery.

Interventions

  • Device: Electrophysiologic therapy
    • Pelvic floor electrophysiological therapy is used after common gynecologic surgery to record anal exhaust time and micturition time after surgery and endometrium recovery of intrauterine adhesions.For intrauterine adhesions patients, Drug: Aspirin(low dose of Aspirin after operation)Device: intrauterine balloon (insert intrauterine balloon after operation)

Arms, Groups and Cohorts

  • Experimental: Electrophysiologic therapy group
    • apply electrophysiologic therapy after surgery
  • No Intervention: non-electrophysiologic therapy group
    • do not apply electrophysiologic therapy after surgery

Clinical Trial Outcome Measures

Primary Measures

  • time of anal exhaust and urination after gynecologic surgery
    • Time Frame: within three days after gynecologic surgery
  • Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
    • Time Frame: Within the first 3 months after surgery

Secondary Measures

  • Menstruation Pattern(Improvement or No Significant Change) of All Participants
    • Time Frame: Within the first 3 months after surgery
  • Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants
    • Time Frame: Within the first 3 months after surgery
    • The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version) [7]. A score of 1-4 was considered to represent mild adhesions, a score of 5-8 was considered to represent moderate adhesions and a score of 9-12 represented severe adhesion
  • Number of Participants With Pregnancy after operation
    • Time Frame: within three years

Participating in This Clinical Trial

Inclusion Criteria

.After electrocision of intrauterine adhesions; .Or after common gynecologic laparoscopic surgery,patients occurred muscle pain or patients occurred urinary retention. Exclusion Criteria:

  • Pregnancy; – Suspected acute inflammation of the genitourinary system; – Postoperative persistent vaginal bleeding; – Patients have vaginal stenosis; – Patients have implantation of a pacemaker with a cardiac pacemaker; – Patients have a malignant pelvic organ tumor; .Patients have nervous system disease (dementia or unstable seizures),who cannot actively cooperate with the treatment.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital, Sun Yat-Sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yuqing Chen, chief physician – First Affiliated Hospital, Sun Yat-Sen University
  • Overall Official(s)
    • Yuqing Chen, Chief, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
  • Overall Contact(s)
    • Yaling Guo, Master, 15622327162, 1106561876@qq.com

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