Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training

Urinary Incontinence Clinical Trial

Official title:

Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training to Treat Female Urinary Incontinence: a Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04150094
• Other study ID #: 2018-0354
• Status: Withdrawn
• Phase: N/A
• Start date: July 10, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: September 2023
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• Pelvic floor muscle training (PFMT)
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.
• Pelvic floor muscle training + intravaginal vibratory stimulus
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.

Locations

Country	Name	City	State
Brazil	José Geraldo Lopes Ramos	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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).	8 weeks