Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training

NCT ID: NCT04150094

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2021-12-20

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pelvic floor muscle training (PFMT)

Pelvic floor muscle training without stimulus.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training (PFMT)

Intervention Type: OTHER

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

Pelvic floor muscle training with intravaginal vibratory stimulation.

Group Type: EXPERIMENTAL

Pelvic floor muscle training + intravaginal vibratory stimulus

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Geraldo Lopes Ramos

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

José Geraldo Lopes Ramos

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

2018-0354

Identifier Type: -

Identifier Source: org_study_id