NCT05272644

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

Status unknown NA Last updated 22 March 2023

What this trial tests

NA trial testing surface electromyographic biofeedback assisted pelvic floor muscle training in Stress Urinary Incontinence in 128 participants. Status unknown.

Timeline

16 September 2022

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Far Eastern Memorial Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	128
Start date	16 September 2022
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• surface electromyographic biofeedback assisted pelvic floor muscle training
• surface electromyographic biofeedback and electrical stimulation

Conditions studied

• Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
• Urethral Hypermobility — all drugs for Urethral Hypermobility →
• Intrinsic Sphincter Deficiency — all drugs for Intrinsic Sphincter Deficiency →

Sponsor

Far Eastern Memorial Hospital

Who can join

Adults 20 to 85, female only, with Stress Urinary Incontinence or Urethral Hypermobility. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.