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

Not Applicable

• Conditions: Pelvic Floor Muscle Electrophysiologic Therapy; Fast-Track Surgery
• Interventions: Device: Electrophysiologic therapy

• Registration Number: NCT03524807
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-04-26
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-13
• Last Update Submitted: 2018-05-13
• Study First Posted: 2018-05-15
• Last Update Posted: 2018-05-15
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrophysiologic therapy group	Electrophysiologic therapy	apply electrophysiologic therapy after surgery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Menstruation Pattern(Improvement or No Significant Change) of All Participants	Within the first 3 months after surgery
Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants	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	within three years

Trial Locations

Locations (1)

the First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China