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A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder

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: NCT02185235
Recruitment Status : Unknown
Verified July 2014 by Tsung-Hsien Su, Mackay Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Tsung-Hsien Su, Mackay Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Incontinence Device: Electrical Stimulation Device: Biofeedback Other: Pelvic Floor Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
Study Start Date : June 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biofeedback & Electrical Stimulation
Twice a week, 20 minutes for each time. One course includes 18 times treatment.
Device: Electrical Stimulation

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.

Other Name: Femiscan Stim (Mega Electronics Ltd)

Device: Biofeedback
Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
Other Name: Femiscan Multi-trainer

Active Comparator: Biofeedback & Pelvic Floor Training
Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.
Device: Biofeedback
Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
Other Name: Femiscan Multi-trainer

Other: Pelvic Floor Training

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 Measures :
  1. 1-Hour Pad test of urine leakage amount (gm) [ Time Frame: Total 18 times of treatment, for 3 months ]

    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 :
  1. Quality of life (score) [ Time Frame: Total 18 times of treatment, for 3 months ]

Other Outcome Measures:
  1. Vaginal pressure (mmHg) [ Time Frame: Total 18 times of treatment, for 3 months ]
    Use the vaginal probe sensor to evaluate the objective level of vaginal squeezing pressure and endurance time



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT02185235


Contacts
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Contact: Tsung-Hsien Su, PhD 886-25433535 ext 2544 drthsu@mail.itrip.com.tw

Locations
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Taiwan
Taiwan, Taipei, Mackay Memorial hospital Recruiting
Taiwan, Taiwan
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
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Principal Investigator: TSUNG H Su, Professor Mackay Memorial Hospital

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Responsible Party: Tsung-Hsien Su, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT02185235    
Other Study ID Numbers: 14MMHIS031
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Keywords provided by Tsung-Hsien Su, Mackay Memorial Hospital:
Electrical stimulation
Biofeedback
Additional relevant MeSH terms:
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Pelvic Floor Disorders
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Pregnancy Complications