Urinary Stress Incontinence Urinary Incontence
Conditions
Interventions
This is a three-arm, blinded, randomized clinical study. Experimental group: 20 women with stress urinary incontinence will receive extracorporeal magnetic stimulation twice a week for 3 weeks. Contro
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
35 Years to 64 Years
Inclusion criteria
Inclusion criteria: Women diagnosed with stress urinary incontinence or mixed urinary incontinence with predominance of the stress component; aged between 35 and 65 years; presenting an Oxford score lower than or equal to 3; and able to complete the questionnaires
Exclusion criteria
Exclusion criteria: Urgency urinary incontinence; Neurological disorders; Active or recurrent genitourinary tract infection; Pelvic organ prolapse grade 2 or higher; Pregnant women or women with suspected pregnancy; Cognitive impairment preventing understanding of the treatment; Presence of a pacemaker, prosthesis, copper intrauterine device, or any other metallic implant; Women using medications that may cause urinary loss or urinary retention as a side effect; Women with active urinary tract infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome: determine which of the interventions proposed in the study methods had the greatest impact on the treatment of stress urinary incontinence — vaginal electrical stimulation or extracorporeal electromagnetic stimulation — and to compare the results obtained with those of the placebo group in the immediate post-treatment period;Observed outcome 1: vaginal electrical stimulation showed more consistent results in the treatment of stress urinary incontinence when compared with extracorporeal electromagnetic stimulation and the sham group | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: compare the scores on the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire – Short Form), between the intervention groups and the placebo group in the immediate post-treatment period and after six months;Observed outcome 2: ICIQ scores were more favorable in the vaginal electrical stimulation group than in the extracorporeal electromagnetic stimulation group and the sham group;Expected outcome 3: compare perineometry values, which assess pelvic floor muscle strength, between the intervention groups and the placebo group in the immediate post-treatment period and after six months;Observed outcome 3: Perineometry values were higher in the vaginal electrical stimulation group than in the extracorporeal electromagnetic stimulation group and the sham group;Expected outcome 4: compare the functional assessment of the pelvic floor muscles, using selected components of the PERFECT scale (power, endurance, repetitions, and fast contractions), between the intervention groups and the placebo group in the immediate post-treatment period and after six months;Observed outcome 4: vaginal electrical stimulation group showed improvement in all PERFECT scale domains compared with the extracorporeal electromagnetic stimulation group and the sham group;Expected outcome 5: compare the voiding profile, assessed using a bladder diary, between the intervention groups and the placebo group in the immediate post-treatment period and after six months;Observed outcome 5: vaginal electrical stimulation group showed improvement in stress urinary leakage and nocturia compared with the extracorporeal electromagnetic stimulation group and the sham group;Expected outcome 6: assess the safety profile of the interventions and determine whether any adverse events occurred after treatment or after six months of follow-up; Observed outcome 6: no adverse events occurred during the intervention treatments;Expected outcome 7: compare the scores on the FSFI | — |
Countries
BR
Contacts
Public ContactAndrea Dell'Aquila
Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed