Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871281
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2023-04-12
Brief Title:
Electrostimulation and PFMT for Stress Urinary Incontinence
Sponsor:
Lithuanian Sports University
Organization:
Lithuanian Sports University
Study Overview
Official Title:
Effects of Pelvic Floor Muscle Training and Electrostimulation on Womens Quality of Life and Pelvic Floor Muscle Function in Stress Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled trial is to evaluate and compare the effects of electrostimulation in addition to pelvic floor muscle training and pelvic floor muscle training alone on pelvic floor muscle PFM function urinary incontinence and quality of life in women with stress urinary incontinence The main questions are
What is the effect of electrostimulation combined with pelvic floor muscle training on pelvic floor muscle function symptoms of urinary incontinence and quality of life in women with stress urinary incontinence What is the effect of pelvic floor muscle training program on pelvic floor muscle function symptoms of urinary incontinence and quality of life in women with stress urinary incontinence Which intervention is more effective - electrostimulation with pelvic floor muscle training or pelvic floor muscle training alone
Participants will be evaluated before and after the interventions with the following methods
International Incontinence Counseling Questionnaire - Short Form ICIQ-SF Pelvic floor muscle strength and endurance will be assessed with a Pelvexiser perineometer
What is the effect of electrostimulation combined with pelvic floor muscle training on pelvic floor muscle function symptoms of urinary incontinence and quality of life in women with stress urinary incontinence What is the effect of pelvic floor muscle training program on pelvic floor muscle function symptoms of urinary incontinence and quality of life in women with stress urinary incontinence Which intervention is more effective - electrostimulation with pelvic floor muscle training or pelvic floor muscle training alone
Participants will be evaluated before and after the interventions with the following methods
International Incontinence Counseling Questionnaire - Short Form ICIQ-SF Pelvic floor muscle strength and endurance will be assessed with a Pelvexiser perineometer
Detailed Description:
The study involved 24 women 20-49 years old who have complained of stress urinary incontinence for at least 4 weeks who gave at least one birth vaginally and signed the consent form Subjects were excluded if they were pregnant were diagnosed with vaginismus urinary tract infections cancer epilepsy pelvic organ prolapse greater than stage I skin diseases had undergone previous pelvic floor surgeries had heart stimulator or metal implant and were unable to contract the PFM Study participants were randomly divided into two groups the I group n12 in which participants underwent pelvic floor muscle training PFMT and the II group n12 in which subjects received pelvic floor muscle exercises combined with electrostimulation PFMESParticipants were evaluated before the interventions and repeated after 4 weeks Before and after the interventions womens quality of life QoL was assessed according to the International Incontinence Counseling Questionnaire - Short Form Perineometry with Pelvexiser perineometer was used to measure pelvic floor muscle strength and endurance and vaginal resting pressure Statistical analysis was performed by IBM SPSS Statistics 260 and Microsoft Excel software 365
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None