Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training

NCT04150094 | Withdrawn

• 1 other identifier: 2018-0354
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Impact in quality of life

  8 weeks

Study Arms (2)

Pelvic floor muscle training (PFMT)

ACTIVE COMPARATOR

Pelvic floor muscle training without stimulus.

Other: Pelvic floor muscle training (PFMT)

Pelvic floor muscle training + intravaginal vibratory stimulus

EXPERIMENTAL

Pelvic floor muscle training with intravaginal vibratory stimulation.

Other: Pelvic floor muscle training + intravaginal vibratory stimulus

Interventions

Pelvic floor muscle training (PFMT) 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 (PFMT)

Pelvic floor muscle training + intravaginal vibratory stimulus 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.

Pelvic floor muscle training + intravaginal vibratory stimulus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

José Geraldo Lopes Ramos

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Geraldo Lopes Ramos

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: July 10, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

BR (1)