Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation

Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation in Women With Urinary Incontinence: a Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Vibratory Perineal Stimulus; Other: Transvaginal Electrical Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Porto Alegre, Brazil, 90035-903
    • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vibratory Perineal Stimulus; It's thought that the vibratory perineal stimulation can produces afferent nerve impulses that goes to the sacral spinal cord (S2-S4) via the pudendal nerve and stimulates the sacral somatic response which will cause the pelvic muscle contraction.	Other: Vibratory Perineal Stimulus; Vibratory perineal stimulus will be applied in patients randomized to this group through an intravaginal probe which emits vibratory pulses, with the device fixed in the following parameters:on time = 8 seconds, off time = 16 seconds, total time = 20 minutes. The intervention time will be 6 weeks, with sessions held once a week.
Active Comparator: Transvaginal Electrical Stimulation; Transvaginal electrical stimulation can produces direct and reflex responses of the pelvic floor muscles, being more effective in patients who can't voluntarily contract this musculature. In addition, it increases blood flow to the muscles, restores neuromuscular connections and improves muscle fiber function.	Other: Transvaginal Electrical Stimulation; The transvaginal electrical stimulation will be applied in patients randomized to this group through an intravaginal probe which emits electrical pulses, with the device fixed in the following parameters: frequency = 50 Hz, pulse width = 300ms,on time = 8 seconds, off time = 16 seconds, total time = 20 minutes. The intervention time will be 6 weeks, with sessions held once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in pelvic floor muscles functionality	Will be assessed by the PERFECT scheme. Each letter that compose the word means a condition to be evaluated: P = power, E = endurance, R = repetitions, F = fast contractions, E = elevation, C=co-contraction, T= cough reflex.	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of urinary Incontinence	ICIQ-SF - "International Consultation on Incontinence Questionnaire - Short Form". This questionnaire assesses the type of urinary loss, intensity and impact on quality of life.	six weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: José Geraldo F Lopes Ramos, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): November 15, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 16-0064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No