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Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training

Primary Purpose

Urinary Incontinence

Status
Withdrawn
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pelvic floor muscle training (PFMT)
Pelvic floor muscle training + intravaginal vibratory stimulus
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women with urinary incontinence;
  • Know how to perform a voluntary pelvic floor muscle contraction;
  • Have not undergone pelvic floor muscle training in the last 6 months;
  • Understand the instruments used in research.

Exclusion Criteria:

  • Latex allergy;
  • Neurological diseases;
  • Pelvic organ prolapse > grade 2;
  • Pain during vaginal palpation and / or introduction of the vaginal probe;
  • Vaginal atrophy;

Sites / Locations

  • José Geraldo Lopes Ramos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pelvic floor muscle training (PFMT)

Pelvic floor muscle training + intravaginal vibratory stimulus

Arm Description

Pelvic floor muscle training without stimulus.

Pelvic floor muscle training with intravaginal vibratory stimulation.

Outcomes

Primary Outcome Measures

Change in urinary incontinence
We will measure it using the "International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - Portuguese version", pre and post treatment, to assess if there are any changes in bladder control after the protocols. It consists of 3 scored items which evaluate the frequency, volume of leakage and overall impact of incontinence. The overall score ranges from 0 to 21, with greater values indicating increased severity. Klovning et al (2009) says that ICIQ-SF may be divided into the following four severity categories of UI: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Lim et al (2019) suggested that for women undergoing nonsurgical treatments for incontinence, reductions of 4 points in ICIQ-UI SF are perceived as clinically meaningful.

Secondary Outcome Measures

Impact in quality of life
We are using the "International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - Portuguese version", which asks about overall impact of UI in quality of life by a scale from 0-10 of how much these symptoms bothered the patient's life. We are going to say the participant "imagine that 0 is if urinary leakage doesn't bother you at all and 10 is as much as this can disrupt your life". There are other questions in this questionnaire according to the severity of the UI symptoms. Each answer has a punctuation and the total score could range between 0 and 21. The higher, the worse is the severity of UI and the impact on the participant's quality of life. The ICIQ is highly recommended (Grade A) for the basic evaluation of the patient's perspective of urinary incontinence (Abrams et al, 2010).

Full Information

First Posted
October 31, 2019
Last Updated
September 21, 2023
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04150094
Brief Title
Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training
Official Title
Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training to Treat Female Urinary Incontinence: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Due to the covid pandemic.
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized blinded trial with non-probabilistic sampling for convenience. Our goal is to compare PFMT with intravaginal vibratory stimulus versus PFMT alone on the treatment of female urinary incontinence.
Detailed Description
This is a randomized blinded trial with non-probabilistic sampling for convenience. Our goal is to compare PFMT with intravaginal vibratory stimulus versus PFMT alone on the treatment of female urinary incontinence. Women with an indication for conservative treatment of urinary incontinence will be referred to the Pelvic Floor Physiotherapy Team by the Medical Team of the Ambulatory of Urogynecology and Obstetrics of the Hospital de Clínicas de Porto Alegre and those who are in compliance with the inclusion criteria proposed for the research will be invited to participate in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor muscle training (PFMT)
Arm Type
Active Comparator
Arm Description
Pelvic floor muscle training without stimulus.
Arm Title
Pelvic floor muscle training + intravaginal vibratory stimulus
Arm Type
Experimental
Arm Description
Pelvic floor muscle training with intravaginal vibratory stimulation.
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle training (PFMT)
Intervention Description
Participants will be firstly evaluated and orientated about pelvic floor muscles and pelvic floor muscle training. They will be clarified about the role of pelvic floor muscles in continence mechanisms and will be orientated to perform 8 weeks of PFMT without stimulus, coming once a week to a session supervised by physiotherapist and will be encouraged to perform the exercises at home during the other week days.
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle training + intravaginal vibratory stimulus
Intervention Description
Participants will be firstly evaluated and orientated about pelvic floor muscles and pelvic floor muscle training. They will be clarified about the role of pelvic floor muscles in continence mechanisms and will be orientated to perform 8 weeks of PFMT with intravaginal vibratory stimulus. They will need to come once a week to a session supervised by physiotherapist to use the vibration device and will be encouraged to perform the exercises at home during the other week days.
Primary Outcome Measure Information:
Title
Change in urinary incontinence
Description
We will measure it using the "International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - Portuguese version", pre and post treatment, to assess if there are any changes in bladder control after the protocols. It consists of 3 scored items which evaluate the frequency, volume of leakage and overall impact of incontinence. The overall score ranges from 0 to 21, with greater values indicating increased severity. Klovning et al (2009) says that ICIQ-SF may be divided into the following four severity categories of UI: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Lim et al (2019) suggested that for women undergoing nonsurgical treatments for incontinence, reductions of 4 points in ICIQ-UI SF are perceived as clinically meaningful.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Impact in quality of life
Description
We are using the "International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - Portuguese version", which asks about overall impact of UI in quality of life by a scale from 0-10 of how much these symptoms bothered the patient's life. We are going to say the participant "imagine that 0 is if urinary leakage doesn't bother you at all and 10 is as much as this can disrupt your life". There are other questions in this questionnaire according to the severity of the UI symptoms. Each answer has a punctuation and the total score could range between 0 and 21. The higher, the worse is the severity of UI and the impact on the participant's quality of life. The ICIQ is highly recommended (Grade A) for the basic evaluation of the patient's perspective of urinary incontinence (Abrams et al, 2010).
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with urinary incontinence; Know how to perform a voluntary pelvic floor muscle contraction; Have not undergone pelvic floor muscle training in the last 6 months; Understand the instruments used in research. Exclusion Criteria: Latex allergy; Neurological diseases; Pelvic organ prolapse > grade 2; Pain during vaginal palpation and / or introduction of the vaginal probe; Vaginal atrophy;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Geraldo Lopes Ramos
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
José Geraldo Lopes Ramos
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The SPSS spreadsheet with relevant research data (characterization of the sample and severity of UI) and statistical analysis may be shared by e-mail request.

Learn more about this trial

Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training

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