A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder
Primary Purpose
Pelvic Organ Prolapse, Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Electrical Stimulation
Biofeedback
Pelvic Floor Training
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Electrical stimulation, Biofeedback
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.
Exclusion Criteria:
- Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device
Sites / Locations
- Taiwan, Taipei, Mackay Memorial hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biofeedback & Electrical Stimulation
Biofeedback & Pelvic Floor Training
Arm Description
Twice a week, 20 minutes for each time. One course includes 18 times treatment.
Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.
Outcomes
Primary Outcome Measures
1-Hour Pad test of urine leakage amount (gm)
A pad test is a tool to used to measure urine leakage amount . Pad testing can be done over a period of time to one hour.
A sanitary napkin is weighed and then worn for sixty minutes, during which time the individual is asked to perform certain activities which may include:
Walking briskly for three minutes
Sitting and then standing ten to twenty times
Walking up and down stairs for one to two minutes
Picking up objects from the floor five to ten times
Coughing twelve times (at various strengths; may be repeated)
Running in place for one minute (may be repeated) The pad is then removed and weighed again to calculate the amount of urine voided.
Secondary Outcome Measures
Quality of life (score)
Full Information
NCT ID
NCT02185235
First Posted
June 11, 2014
Last Updated
November 2, 2022
Sponsor
Mackay Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02185235
Brief Title
A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder
Official Title
To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse (POP), and fecal incontinence-which often occur together.
Pelvic floor disorders impair multiple aspects of the life quality, including the sexual function of women.
Surgery became the first choice of treatment, however, and not until 1980s was the renewed interest in conservative therapies.
This may be because of higher awareness among women and cost of and morbidity after surgery.
The conservative treatment included pelvic floor muscle training, electrical stimulation, vaginal cones, and biofeedback.
The outcome was up to 35~70 % improved rate as the literature before. Current guidelines recommended conservative management as a first-line therapy. However, there was no consistent consensus on this issue due to variations in stimulation parameters、adjuvant concurrent modality or duration of treatment course, and insufficient result about large and long term follow up of randomized- controlled studies.
Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary incontinence, chronic pelvic pain etc.).
At the aspect of Quality of life, our studies tried to focus on the different domains of pelvic disorder and sexual quality by means of validated questionnaire more objectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Incontinence
Keywords
Electrical stimulation, Biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback & Electrical Stimulation
Arm Type
Experimental
Arm Description
Twice a week, 20 minutes for each time. One course includes 18 times treatment.
Arm Title
Biofeedback & Pelvic Floor Training
Arm Type
Active Comparator
Arm Description
Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.
Intervention Type
Device
Intervention Name(s)
Electrical Stimulation
Other Intervention Name(s)
Femiscan Stim (Mega Electronics Ltd)
Intervention Description
The Chartered Society of Physiotherapy recommends the following standard for electrical devices.
Frequency: 35 Hertz. Pulse width: 250µs (0.25ms). Current type: bi-phasic rectangular. Intensity: maximum tolerated. Duty-cycle: 5 seconds on/10 seconds off. Very weak muscles: 5 seconds on/15 seconds off.
Treatment time: 5 minutes initially, gradually increasing to 20 minutes.
Intervention Type
Device
Intervention Name(s)
Biofeedback
Other Intervention Name(s)
Femiscan Multi-trainer
Intervention Description
Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Training
Intervention Description
First, as you are sitting or lying down, try to contract the muscles you would use to stop urinating To contract the pelvic muscles, squeeze for 3 seconds and then relax for 3 seconds.
Repeat this exercise to 20 minutes each session.
Primary Outcome Measure Information:
Title
1-Hour Pad test of urine leakage amount (gm)
Description
A pad test is a tool to used to measure urine leakage amount . Pad testing can be done over a period of time to one hour.
A sanitary napkin is weighed and then worn for sixty minutes, during which time the individual is asked to perform certain activities which may include:
Walking briskly for three minutes
Sitting and then standing ten to twenty times
Walking up and down stairs for one to two minutes
Picking up objects from the floor five to ten times
Coughing twelve times (at various strengths; may be repeated)
Running in place for one minute (may be repeated) The pad is then removed and weighed again to calculate the amount of urine voided.
Time Frame
Total 18 times of treatment, for 3 months
Secondary Outcome Measure Information:
Title
Quality of life (score)
Time Frame
Total 18 times of treatment, for 3 months
Other Pre-specified Outcome Measures:
Title
Vaginal pressure (mmHg)
Description
Use the vaginal probe sensor to evaluate the objective level of vaginal squeezing pressure and endurance time
Time Frame
Total 18 times of treatment, for 3 months
Title
Urodynamics data analysis
Description
Use urodyanmic examinations for evaluation of bladder function
Time Frame
Total 18 times of treatment, for 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.
Exclusion Criteria:
Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsung-Hsien Su, PhD
Phone
886-25433535
Ext
2544
Email
drthsu@mail.itrip.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TSUNG H Su, Professor
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taiwan, Taipei, Mackay Memorial hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder
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