Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation

NCT03273309 | Completed

• 1 other identifier: 16-0064
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement of urinary Incontinence

  six weeks

Study Arms (2)

Vibratory Perineal Stimulus

ACTIVE COMPARATOR

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

Transvaginal Electrical Stimulation

ACTIVE COMPARATOR

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

Interventions

Vibratory Perineal Stimulus OTHER

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.

Vibratory Perineal Stimulus

Transvaginal Electrical Stimulation OTHER

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.

Transvaginal Electrical Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• José Geraldo F Lopes Ramos

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: September 6, 2017
• Study Start: June 1, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: March 12, 2018

Record last verified: 2017-08

Locations

BR (1)