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

NCT05272644 | Unknown

• 1 other identifier: 109184-F
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence; Urethral Hypermobility; Intrinsic Sphincter Deficiency

Outcome Measures

Primary Outcomes (4)

• 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 .

  Time Frame: through study completion, an average of 8 weeks

• A five-item Self-Assessment of Treatment (SAT)

  to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .

  Time Frame: through study completion, an average of 8 weeks.

• Sandvik urinary incontinence severity test

  The Sandvik test was developed by Sandvik et al to be used as a simple way to calculate severity of urinary incontinence in women. Answer the two questions below and your result will be displayed (Severity Index Score).

  Time Frame: through study completion, an average of 8 weeks

• Symptom Indexes for Stress Incontinence

  assigning a grade based on a clinical history of incontinence: grade 1-only on Severe coughing, sneezing, lifting heavy objects, lifting heavy objects, jumping; grade 2-on walking or running; grade 3-on walking, doing housework (eg washing dishes, sweeping the floor), changing posture (eg from standing to squatting or sitting...);grade 4-on Resting state, such as turning over in bed

  Time Frame: through study completion, an average of 8 weeks

Secondary Outcomes (3)

• Introital and transvaginal ultrasound in the assessment of urogenital and pelvic floor dysfunction

  Time Frame: through study completion, an average of 8 weeks

• one-hour pad test

  Time Frame: through study completion, an average of 8 weeks

• change of electromyographic activity

  Time Frame: through study completion, an average of 8 weeks

Study Arms (4)

urethral hypermobility-surface electromyographic biofeedback only

ACTIVE COMPARATOR

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

Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle training

urethral hypermobility-surface electromyographic biofeedback and electrical stimulation

EXPERIMENTAL

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

Behavioral: surface electromyographic biofeedback and electrical stimulation

intrinsic sphincter deficiency-surface electromyographic biofeedback only

ACTIVE COMPARATOR

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

Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle training

intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation

EXPERIMENTAL

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

Behavioral: surface electromyographic biofeedback and electrical stimulation

Interventions

surface electromyographic biofeedback assisted pelvic floor muscle training BEHAVIORAL

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

intrinsic sphincter deficiency-surface electromyographic biofeedback only; urethral hypermobility-surface electromyographic biofeedback only

surface electromyographic biofeedback and electrical stimulation BEHAVIORAL

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

intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation; urethral hypermobility-surface electromyographic biofeedback and electrical stimulation

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• overactivity bladder for more than 3 months
• more then 20 year old,less then 85 year old and acceptable to receive vaginal examination
• 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

You may not qualify if:

• Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc.
• Kidney disease
• Liver disease
• Patients with cardiac rhythm devices.
• Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises.
• Women during pregnancy.
• Maternity within six weeks after delivery

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Central Study Contacts

Wen-Yih Wu

CONTACT

88689667000; wenyih@gmail.com

Far Eastern Memorial Hospital

CONTACT

88689667000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 128 women with stress urinary incontinence will be divided into two groups: urethral hypermobility and intrinsic sphincter deficiency; and they will be further randomized to 2 arms: surface electromyographic biofeedback arm, surface electromyographic biofeedback and electrical stimulation arm

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: September 16, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

TW (1)