Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03524807
Recruitment Status : Unknown
Verified May 2018 by Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Pelvic Floor Muscle Electrophysiologic Therapy Fast-Track Surgery Device: Electrophysiologic therapy Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Electrophysiologic therapy group
apply electrophysiologic therapy after surgery
 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)
Other Name: pelvic floor muscle electrophysiologic therapy
No Intervention: non-electrophysiologic therapy group
do not apply electrophysiologic therapy after surgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. time of anal exhaust and urination after gynecologic surgery [ Time Frame: within three days after gynecologic surgery ]
  2. Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound [ Time Frame: Within the first 3 months after surgery ]

Secondary Outcome Measures :
  1. Menstruation Pattern(Improvement or No Significant Change) of All Participants [ Time Frame: Within the first 3 months after surgery ]
  2. 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

  3. Number of Participants With Pregnancy after operation [ Time Frame: within three years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524807


Contacts
Layout table for location contacts
Contact: Yaling Guo, Master 15622327162 1106561876@qq.com
Contact: Yuqing Chen, Chief 13724067575 fangchenyq@163.com

Locations
Layout table for location information
China, Guangdong
the First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yaling Guo, Master    15622327162    1106561876@qq.com   
Contact: Yuqing Chen, Chief    13724067575    fangchenyq@163.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Layout table for investigator information
Principal Investigator: Yuqing Chen, Chief First Affiliated Hospital, Sun Yat-Sen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yuqing Chen, chief physician, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03524807    
Other Study ID Numbers: electrophysiologic treatment
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University:
pelvic floor muscle electrophysiologic therapy
enhanced recovery
muscle soreness
 postoperative retention of urine
Intrauterine Adhesions
enhanced recovery after gynecologic surgery