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Physiotherapy in Stress Urinary Incontinence

L

Lithuanian Sports University

Status

Completed

Conditions

Urinary Incontinence,Stress

Treatments

Other: functional magnetic stimulation
Other: pelvic floor muscle training program

Study type

Interventional

Funder types

Other

Identifiers

NCT05721807
LithuanianSportsU-13

Details and patient eligibility

About

The goal of this randomized controlled trial is to evaluate and compare the effects of functional magnetic stimulation and pelvic floor muscle training on pelvic floor muscle function, urinary incontinence symptoms and quality of life in women with stress urinary incontinence. The main questions it aims to answer are:

  • What is the effect of functional magnetic stimulation 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 - functional magnetic stimulation or pelvic floor muscle training program?

Participants will be evaluated before and after the intervention with the following methods:

  • International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF);
  • Incontinence Impact Questionnaire-Short Form (IIQ-7);
  • Pelvic floor muscle strength and endurance will be assessed with a "Pelvexiser" perineometer.

Full description

The study was performed in the period of 07/21/2021-30/10/2021. The study included 48 women 29-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave birth and signed the consent form. Women complaining of vaginismus, suffering from urinary tract infection, cancer, epilepsy or skin conditions with implanted pacemakers, metal implants and pregnant women were excluded from the study. Study participants were randomly divided into two groups: the I group (n=24), in which participants underwent functional magnetic stimulation (FMS) and the II group (n=24) in which subjects received pelvic floor muscle training (PFMT) program. Participants were evaluated before the intervention and repeated after 6 weeks. Subjects responded to a general questionnaire before the intervention, before and after the intervention, the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and Incontinence Impact Questionnaire-Short Form (IIQ-7) were used to assess the symptoms of urinary incontinence and their impact on quality of life. Pelvic floor muscle strength and endurance were assessed with a "Pelvexiser" perineometer. Statistical analysis was performed by IBM SPSS Statistics 26.0 and Microsoft Excel software 365.

Enrollment

48 patients

Sex

Female

Ages

29 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • complains of stress incontinence for at least 4 weeks;
  • women who have given birth.

Exclusion criteria

  • pregnancy;
  • vaginism;
  • urinal infection;
  • oncological disorders;
  • epilepsy;
  • skin problems;
  • if they had an implanted heart pacemaker, metal implants.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

functional magnetic stimulation
Experimental group
Description:
functional magnetic stimulation for stress urinary incontinence
Treatment:
Other: functional magnetic stimulation
pelvic floor muscle training program
Experimental group
Description:
exercise program for pelvic floor muscle
Treatment:
Other: pelvic floor muscle training program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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