Clinical trial NCT05871281: Electrostimulation and PFMT for Stress Urinary Incontinence
Official title: Effects of Pelvic Floor Muscle Training and Electrostimulation on Women's Quality of Life and Pelvic Floor Muscle Function in Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Keywords: stress incontinence
pelvic floor
electrostimulation
muscle training
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a four week, single blinded randomized controlled trial with pre-post design comparing PFM training group with PFM electrostimulation
Primary purpose: TREATMENT

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.

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 (n=12), in which participants underwent pelvic floor muscle training (PFMT) and the II group (n=12) in which subjects received pelvic floor muscle exercises combined with electrostimulation (PFMES).Participants were evaluated before the interventions and repeated after 4 weeks. Before and after the interventions, women's 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 26.0 and Microsoft Excel software 365.

Eligibility criteria: Inclusion Criteria:

* Have given birth at least once
* Voluntary consent to participate in the study
* Do not have concomitant diseases
* Do not use hormonal drugs.

Exclusion Criteria:

* Less than three months have passed after childbirth
* Have heart implants or other metal implants
* Pregnancy

Primary outcomes:
measure: Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)
timeFrame: Change from Baseline Quality of Life at 4 weeks
measure: Pelvic floor muscle strength and endurance
timeFrame: Change from Baseline Pelvic floor Muscle Strength and Endurance at 4 weeks
measure: Resting vaginal pressure
timeFrame: Change from Baseline Resting Vaginal Prressure at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
affiliation: Lithuanian Sports University, Lithuania
name: Vilma Dudoniene, PhD
role: STUDY_CHAIR
References: