Clinical trial NCT03524807: Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery
Official title: Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Muscle Electrophysiologic Therapy
Fast-Track Surgery
Keywords: pelvic floor muscle electrophysiologic therapy
enhanced recovery
muscle soreness
postoperative retention of urine
Intrauterine Adhesions
enhanced recovery after gynecologic surgery
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: time of anal exhaust and urination after gynecologic surgery
timeFrame: within three days after gynecologic surgery
measure: Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
timeFrame: Within the first 3 months after surgery
Secondary outcomes:
measure: Menstruation Pattern(Improvement or No Significant Change) of All Participants
timeFrame: Within the first 3 months after surgery
measure: Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants
timeFrame: Within the first 3 months after surgery
measure: Number of Participants With Pregnancy after operation
timeFrame: within three years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yuqing Chen, Chief
role: PRINCIPAL_INVESTIGATOR
References: