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

Mackay Memorial Hospital

Status: Enrolling

Conditions: Pelvic Organ Prolapse; Incontinence

Treatments: Device: Biofeedback; Device: Electrical Stimulation; Other: Pelvic Floor Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02185235

14MMHIS031

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Biofeedback & Electrical Stimulation

Experimental group

Description:

Twice a week, 20 minutes for each time. One course includes 18 times treatment.

Treatment:

Device: Electrical Stimulation

Device: Biofeedback

Biofeedback & Pelvic Floor Training

Active Comparator group

Description:

Pelvic floor training every 20 minutes for each time, twice a week. and total for 18 times.

Treatment:

Other: Pelvic Floor Training

Device: Biofeedback