CClinicalTrials.gg
Status unknownNCT03524807Updated May 15, 2018

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

An interventional study of Electrophysiologic therapy in Pelvic Floor Muscle Electrophysiologic Therapy and Fast-Track Surgery, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • 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
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In context

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

.After electrocision of intrauterine adhesions;

.Or after common gynecologic laparoscopic surgery,patients occurred muscle pain or patients occurred urinary retention.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Electrophysiologic therapy group

    apply electrophysiologic therapy after surgery

    Device: Electrophysiologic therapy

  • No intervention
    non-electrophysiologic therapy group

    do not apply electrophysiologic therapy after surgery

Interventions

  • DeviceElectrophysiologic 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)

    Also known as: pelvic floor muscle electrophysiologic therapy

06

What researchers measure

Primary outcomes

  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 outcomes

  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

    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

    Time frame: Within the first 3 months after surgery

  3. Number of Participants With Pregnancy after operation

    Time frame: within three years

07

Study locations

1 of 1 sites recruiting
  • the First Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03524807
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Yuqing Chen (chief physician, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
May 15, 2018
Start date
Mar 1, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
May 15, 2018

Study contacts

Yaling Guo, Master
Contact
1106561876@qq.com
15622327162
Yuqing Chen, Chief
Contact
fangchenyq@163.com
13724067575
Yuqing Chen, Chief
principal investigator · First Affiliated Hospital, Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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