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Trial record 18 of 626 for:    transvaginal

Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation

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ClinicalTrials.gov Identifier: NCT03273309
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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


Condition or disease Intervention/treatment Phase
Urinary Incontinence Other: Vibratory Perineal Stimulus Other: Transvaginal Electrical Stimulation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation in Women With Urinary Incontinence: a Randomized Clinical Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Improvement in pelvic floor muscles functionality [ Time Frame: six weeks ]
    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.


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273309


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: José Geraldo F Lopes Ramos Hospital de Clínicas de Porto Alegre

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03273309     History of Changes
Other Study ID Numbers: 16-0064
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders