Pelvic Floor Muscle Electrophysiologic TherapyNCT03524807
Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery
A study testing Electrophysiologic therapy in people with Pelvic Floor Muscle Electrophysiologic Therapy and Fast-Track Surgery, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pelvic Floor Muscle Electrophysiologic Therapy, Fast-Track Surgery
- What is being tested?
- Electrophysiologic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- .After electrocision of intrauterine adhesions;
- .Or after common gynecologic laparoscopic surgery，patients occurred muscle pain or patients occurred urinary retention.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yaling Guo, Master, 15622327162, 1106561876@qq.com
Yuqing Chen, Chief, 13724067575, fangchenyq@163.com
About this study
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.
Read the 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.
- Being tested
- Electrophysiologic therapy
- Keywords
- pelvic floor muscle electrophysiologic therapy, enhanced recovery, muscle soreness, postoperative retention of urine, Intrauterine Adhesions, enhanced recovery after gynecologic surgery
- Medical subject headings
- Myalgia, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiologic therapyDevice
Also called pelvic floor muscle 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)
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiologic therapy group | Experimental | apply electrophysiologic therapy after surgery Receives: Device: Electrophysiologic therapy |
| non-electrophysiologic therapy group | No intervention | do not apply electrophysiologic therapy after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of anal exhaust and urination after gynecologic surgery
Measured: within three days after gynecologic surgery
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Measured: Within the first 3 months after surgery
Secondary outcomes (3)
Menstruation Pattern(Improvement or No Significant Change) of All Participants
Measured: Within the first 3 months after surgery
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
Measured: Within the first 3 months after surgery
Number of Participants With Pregnancy after operation
Measured: within three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle Electrophysiologic TherapyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yuqing Chen, Chief, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524807
- Sponsor's protocol ID
- electrophysiologic treatment
- Status last verified
- May 2018
- First submitted
- 26 Apr 2018
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Muscle Electrophysiologic Therapy on Enhanced Recovery After Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT03524807
- Acronym / sponsor ID
- electrophysiologic treatment
- Keywords
- pelvic floor muscle electrophysiologic therapy, enhanced recovery, muscle soreness, postoperative retention of urine, Intrauterine Adhesions, enhanced recovery after gynecologic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrophysiologic therapy group | Experimental | Device: Electrophysiologic therapyapply electrophysiologic therapy after surgery |
| non-electrophysiologic therapy group | No intervention | –do not apply electrophysiologic therapy after surgery |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- .After electrocision of intrauterine adhesions;
- .Or after common gynecologic laparoscopic surgery，patients occurred muscle pain or patients occurred urinary retention.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiologic therapyAlso: pelvic floor muscle electrophysiologic therapyPelvic 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) | Device | Electrophysiologic therapy group |
Primary outcome
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
3 secondary outcomes
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
Number of Participants With Pregnancy after operation
Time frame: within three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuqing Chen, Chief principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiologic therapy in people with Pelvic Floor Muscle Electrophysiologic Therapy and Fast-Track Surgery, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaling Guo, Master (15622327162, 1106561876@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of anal exhaust and urination after gynecologic surgery (time frame: within three days after gynecologic surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.