Clinical trial NCT03273309: Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation
Official title: Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation in Women With Urinary Incontinence: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To compare the effects of Vibratory Perineal Stimulus with transvaginal electrical stimulation to the pelvic floor muscles functionality in women with urinary incontinence and who are unable to voluntarily contract their pelvic floor muscles.

Study Design: Randomized controlled trial

Detailed description: * The purpose of this study is to find out the effect of vibratory perineal stimulus compared to transvaginal electrical stimulation on the functionality of pelvic floor muscles in women with urinary incontinence who are unable to perform voluntary contraction of this musculature.
* Study Design: Randomized controlled trial
* Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed.and in the Clinical Research Center of the same hospital.
* Inclusion criteria: women with urinary incontinence with zero or one strength degree of pelvic floor muscle contraction by the Modified Oxford Scale.
* Main outcome: Improvement the functionality of pelvic floor muscles
* Secondary outcome: Improvement of urinary loss
* First protocol: patients will be referred by the medical team and will undergo physiotherapeutic evaluation to collect personal data, check the symptoms of urinary incontinence, apply a quality of life questionnaire and measure pelvic floor muscles strength. If patient has zero or one degree of pelvic floor muscle strength, will be referred to the second phase.
* Second protocol: Patients will be randomized into two groups - Vibratory stimulus group or electrical stimulation group. Both will follow a 6-week treatment protocol with intervention once a week. Both are intravaginal devices applied for 20 minutes, with on cycle of 8 seconds and off cycle of 16 seconds.
* Final protocol: patients will repeat the initial evaluation.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of urinary incontinence;
* To be unable to perform a voluntarily contraction of pelvic floor muscles;
* Understand the instruments used in the research;

Exclusion Criteria:

* Allergy to latex;
* Individual or group pelvic floor muscle training in the last 6 months.

Primary outcomes:
measure: Improvement in pelvic floor muscles functionality
timeFrame: six weeks
Secondary outcomes:
measure: Improvement of urinary Incontinence
timeFrame: six weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: José Geraldo F Lopes Ramos
role: PRINCIPAL_INVESTIGATOR
References: