Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training

Not Applicable

Withdrawn

• Conditions: Urinary Incontinence
• Interventions: Other: Pelvic floor muscle training (PFMT); Other: Pelvic floor muscle training + intravaginal vibratory stimulus

• Registration Number: NCT04150094
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2019-07-10
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-04
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic floor muscle training (PFMT)	Pelvic floor muscle training (PFMT)	Pelvic floor muscle training without stimulus.
Pelvic floor muscle training + intravaginal vibratory stimulus	Pelvic floor muscle training + intravaginal vibratory stimulus	Pelvic floor muscle training with intravaginal vibratory stimulation.

Primary Outcome Measures

Name	Time	Method
Change in urinary incontinence	8 weeks	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

Name	Time	Method
Impact in quality of life	8 weeks	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).

Trial Locations

Locations (1)

José Geraldo Lopes Ramos; 🇧🇷 Porto Alegre, RS, Brazil