NCT03524807

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

April 26, 2018

Last Update Submit

May 13, 2018

Conditions

Pelvic Floor Muscle Electrophysiologic TherapyFast-Track Surgery

Keywords

pelvic floor muscle electrophysiologic therapyenhanced recoverymuscle sorenesspostoperative retention of urineIntrauterine Adhesionsenhanced recovery after gynecologic surgery

Outcome Measures

Primary Outcomes (2)

  • time of anal exhaust and urination after gynecologic surgery

    within three days after gynecologic surgery

  • Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

    Within the first 3 months after surgery

Secondary Outcomes (3)

  • Menstruation Pattern(Improvement or No Significant Change) of All Participants

    Within the first 3 months after surgery

  • Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants

    Within the first 3 months after surgery

  • Number of Participants With Pregnancy after operation

    within three years

Study Arms (2)

Electrophysiologic therapy group

EXPERIMENTAL

apply electrophysiologic therapy after surgery

Device: Electrophysiologic therapy

non-electrophysiologic therapy group

NO INTERVENTION

do not apply electrophysiologic therapy after surgery

Interventions

Electrophysiologic therapyDEVICE

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
Electrophysiologic therapy group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • After electrocision of intrauterine adhesions;
  • Or after common gynecologic laparoscopic surgery，patients occurred muscle pain or patients occurred urinary retention.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

MyalgiaGynatresia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yuqing Chen, Chief

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaling Guo, Master

CONTACT

156223271621106561876@qq.com

Yuqing Chen, Chief

CONTACT

13724067575fangchenyq@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 15, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

CN(1)