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

Study Overview
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Brief Summary
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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.

Official Title
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To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women

Conditions
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Pelvic Organ Prolapse, Incontinence

Intervention / Treatment
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* Device: Electrical Stimulation
* Device: Biofeedback
* Other: Pelvic Floor Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback & Electrical Stimulation<br>Twice a week, 20 minutes for each time. One course includes 18 times treatment. | Device: Electrical Stimulation<br>* 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.<br>* Other names: Femiscan Stim (Mega Electronics Ltd);Device: Biofeedback<br>* Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies<br>* Other names: Femiscan Multi-trainer;|
| Active Comparator: Biofeedback & Pelvic Floor Training<br>Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times. | Device: Biofeedback<br>* Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies<br>* Other names: Femiscan Multi-trainer;Other: Pelvic Floor Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Total 18 times of treatment, for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (score) |  | Total 18 times of treatment, for 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical stimulation, Biofeedback