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

Fast-Track Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03524807
• Other study ID #: electrophysiologic treatment
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2018
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Yaling Guo, Master
• Phone: 15622327162
• Email: 1106561876[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fast-Track Surgery
• Pelvic Floor Muscle Electrophysiologic Therapy

Intervention

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)

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of anal exhaust and urination after gynecologic surgery		within three days after gynecologic surgery
Primary	Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound		Within the first 3 months after surgery
Secondary	Menstruation Pattern(Improvement or No Significant Change) of All Participants		Within the first 3 months after surgery
Secondary	Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants	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	Within the first 3 months after surgery
Secondary	Number of Participants With Pregnancy after operation		within three years