NCT02501317

Brief Summary

Introduction: Urinary incontinence is a condition that affects most women in her adult life; it is considered a public health problem and has a high negative impact on the quality of life. Physical therapy is considered as the first treatment option for this disease, these treatments are done with pelvic floor muscles exercises (kinesiotherapy) with or without the use of other resources such as biofeedback, electrical stimulation and vaginal cones. Rationale: The protocols used in the various studies on the treatment of urinary incontinence are made with only one type of therapy and have no change in the intensity of the exercises. The "Active Perineal Rehabilitation" protocol uses kinesiotherapy with biofeedback, electrical stimulation, vaginal cones and home exercises; it consists of 14 individual sessions that gradually evolve the intensity of exercises. Objective: To assess the scientific validity of "Active Perineal Rehabilitation" protocol for the treatment of urinary incontinence. Methodology: A multicenter, prospective clinical trial, controlled and randomized, the sample will be divided into a study group that will be treated with the Active Perineal Rehabilitation protocol, and a control group will be treated with the protocol already widely used. Keys Words: urinary incontinence, physical therapy, rehabilitation, pelvic floor, perineum, conservative treatment

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

July 10, 2015

Last Update Submit

July 15, 2015

Conditions

Urinary Incontinence

Keywords

urinary incontinencephysical therapyrehabilitationpelvic floorperineumconservative treatment

Outcome Measures

Primary Outcomes (1)

  • Urinary loss frequency

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and stress test

    6 months

Secondary Outcomes (2)

  • Quality of life

    6 months

  • Sexual satisfaction

    6 months

Study Arms (2)

Active Perineal Rehabilitation protocol

EXPERIMENTAL

study group that will be treated with "Active Perineal Rehabilitation" protocol

Behavioral: Active Perineal Rehabilitation protocol

Kari Bo protocol

ACTIVE COMPARATOR

control group will be treated with the protocol already widely used

Behavioral: Kari Bo protocol

Interventions

Active Perineal Rehabilitation protocolBEHAVIORAL

Active Perineal Rehabilitation Protocol available in http://www.perineo.info/wordpress/book-active-perineal-rehabilitation/

Active Perineal Rehabilitation protocol
Kari Bo protocolBEHAVIORAL

Group exercises to pelvic floor rehabilitation

Kari Bo protocol

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women diagnosticated with stress urinary incontinence, with stress test positive; and age between 20 to 75 years old.

You may not qualify if:

  • Pregnancy
  • Metallic intrauterine device
  • Unable to understand physical therapist orientations
  • Urinary infection
  • Virginity
  • Prolapse grade 2 or more
  • Previous pelvic surgery
  • Previous treatment to urinary incontinence in the last 6 months before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laira Ramos, master

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 17, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

September 1, 2018

Last Updated

July 17, 2015

Record last verified: 2015-07