Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence

Far Eastern Memorial Hospital128 enrolled

Overview

The pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. Pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. Biofeedback uses an instrument to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and present this information back to the woman in auditory or visual form. Electrical stimulation can aid in detecting pelvic floor muscles, and also promote the contraction of the pelvic floor muscles and strengthen the muscles. This study assumes that urinary incontinence women with different pathophysiological classifications receiving a pelvic floor muscle training with surface electromyographic biofeedback and electrical stimulation show differences in the strength of pelvic muscle and degree of symptoms improvement.

Participant will be assigned randomly to biofeedback-assisted pelvic floor muscle training (PFMT) group and biofeedback-assisted pelvic floor muscle training (PFMT) combined with electrical stimulation group. Each of the participant will receive the therapy for two months.The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with stress urinary incontinence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Stress Urinary Incontinence

Interventions

surface electromyographic biofeedback assisted pelvic floor muscle trainingBEHAVIORAL

participants will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months

surface electromyographic biofeedback and electrical stimulationBEHAVIORAL

participants will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. overactivity bladder for more than 3 months 2. more then 20 year old,less then 85 year old and acceptable to receive vaginal examination 3. need to match schedule with the investigator's clinic for 45 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvic floor muscle exercises Exclusion Criteria: 1. Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc. 2. Kidney disease 3. Liver disease 4. Patients with cardiac rhythm devices. 5. Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises. 6. Women during pregnancy. 7. Maternity within six weeks after delivery

Outcomes

Primary Outcomes

King's Health Questionnaire (KHQ)

KHQ has 3 parts consisting of 21 items. Part 1 contains general health perception and incontinence impact (one item each). Part 2 contains role limitations, physical limitations, social limitations (two items each), personal relationships, emotions (three items each) and sleep/energy (two items), severity measures (four items).Part 3 is considered as a single item and contains ten responses in relation to frequency, nocturia, urgency,urge, stress, intercourse incontinence, nocturnal enuresis,infections, pain, and difficulty in voiding. The 4 subscales scored between 1 (best) and 4 (worst) in part 1 and 2. The Symptom Severity scale is scored from 0 (best) to 3 (worst) in part 3 .