search
Back to results

Posture in Abdominopelvic Training in Women SUI (QoL SUI)

Primary Purpose

Female Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
abdominopelvic exercise and posture
abdominopelvic exercise
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Stress Incontinence focused on measuring stress urinary incontinence, abdominopelvic exercise, quality of life

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • SUI or stress-predominant mixed UI
  • diagnosed via clinical assessment and urodynamic study
  • Estrogenic deficit.: perimenopause, menopause, postmenopause

Exclusion Criteria:

  • grade 3-4 prolapse,
  • functional alterations (Barthel Scale > 85 points),
  • neurological or cognitive alterations (mini mental examination > 24 points)
  • other predominant type of urinary incontinence.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    abdominopelvic exercise and posture

    abdominopelvic exercise

    Arm Description

    N=21 received supervised physiotherapy abdominopelvic exercise previous postural correction.

    N=21 received supervised physiotherapy abdominopelvic exercise.

    Outcomes

    Primary Outcome Measures

    Changes from Quality of life. KHQ
    The questionnaire KHQ consists of 30 items distributed in 9 dimensions that we expose below, the scores of this questionnaire vary from 0 to 100, each item presents a scale type Likert with four options of response. The score of the KHQ questionnaire can be globally with a range of 0 (which indicates better health-related quality of life) at 100 points (indicating a worse quality of life)
    Changes from Quality of life. ICIQ-IU-SF
    t consists of four questions that assess the presence of urge urinary incontinence, the amount of fluid evacuated and the involvement of the quality of life. The final score oscillates from 0-21, indicating higher scores to greater severity of the IU.
    Treatment satisfaction
    Visual analogic scale (VAS, 0-10, 0=minimum score, 10=maximum score). Higher values represent a better outcome (less treatment satisfaction)
    Changes from IU impact. KHQ
    Question nº2 of KHQ measured IU impact in patient's life. Is a Likert scale 0-4 punctuation ( 0= no proceed, 4= A lot)
    Changes from IU impact.ICIQ-IU-SF
    Question nº3 of ICIQ-IU-SF, measured IU impact in patient's life.Is a numeric scale (1-10),(1= none and 10= a lot )

    Secondary Outcome Measures

    Full Information

    First Posted
    October 28, 2018
    Last Updated
    October 31, 2018
    Sponsor
    University of Valencia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03727945
    Brief Title
    Posture in Abdominopelvic Training in Women SUI
    Acronym
    QoL SUI
    Official Title
    Posture Correction in Abdominopelvic Training in Women With Stress Urinary Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Valencia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Measure effect of postural correction in abdominopelvic exercises on the improvement of the quality of life in patients with SUI. 42 women aged between 46-75 with SUI and stress-predominant mixed urinary incontinence. There were randomly assigned two groups of different treatment. Quality of life was measured by questionnaires: Incontinence Questionnaire Short Form (ICIQ-IU-SF) and King's Health Questionnaire (KHQ) global punctuation and incontinence impact. Treatment satisfaction was measured by VAS scale.
    Detailed Description
    The aim of this study was compare the effect of postural correction in abdominopelvic exercises on the improvement of the quality of life in patients with stress urinary incontinence (SUI). Was a randomized 2-treatment parallel design study. The sample consist in 42 women aged between 46-75 with stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (IUM). They were randomly assigned to two groups: Group 1 (n=21) who received abdomino-pelvic training, and Group 2(n=21) who received the above treatment, guidelines about postural correction. Both groups received 12 treatment sessions in first session information regarding clinical and demographical aspects will be collected. To evaluate results of postural correction combined with abdominopelvic exercise women was assessed:at initial session, post- intervention and 3 months post-intervention treatment.Quality of life was measured by spanish validation questionnaires: International Continence Questionnaire Short Form (ICIQ-IU-SF) and King's Health Questionnaire (KHQ) global punctuation and incontinence impact. Treatment satisfaction was measured by Visual analogic scale (VAS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female Stress Incontinence
    Keywords
    stress urinary incontinence, abdominopelvic exercise, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 aleatorized groups; control group (n=21) and intervention group
    Masking
    Participant
    Masking Description
    Urolog was not involved in physiotherapy treatment, randomised patients previous of treatment.
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    abdominopelvic exercise and posture
    Arm Type
    Experimental
    Arm Description
    N=21 received supervised physiotherapy abdominopelvic exercise previous postural correction.
    Arm Title
    abdominopelvic exercise
    Arm Type
    Experimental
    Arm Description
    N=21 received supervised physiotherapy abdominopelvic exercise.
    Intervention Type
    Other
    Intervention Name(s)
    abdominopelvic exercise and posture
    Intervention Description
    n=21 women received supervised abdominopelvic exercise with previous postural correction. During 12 sessions a specialized physiotherapist supervised to realization of progressive abdominopelvic exercises, previous explain postural correction pelvis, cervical and dorsal zone.
    Intervention Type
    Other
    Intervention Name(s)
    abdominopelvic exercise
    Intervention Description
    n=21 women received supervised abdominopelvic exercise. During 12 sessions a specialized physiotherapist supervised to realization of progressive abdominopelvic exercises.
    Primary Outcome Measure Information:
    Title
    Changes from Quality of life. KHQ
    Description
    The questionnaire KHQ consists of 30 items distributed in 9 dimensions that we expose below, the scores of this questionnaire vary from 0 to 100, each item presents a scale type Likert with four options of response. The score of the KHQ questionnaire can be globally with a range of 0 (which indicates better health-related quality of life) at 100 points (indicating a worse quality of life)
    Time Frame
    baseline,3 months,6 months
    Title
    Changes from Quality of life. ICIQ-IU-SF
    Description
    t consists of four questions that assess the presence of urge urinary incontinence, the amount of fluid evacuated and the involvement of the quality of life. The final score oscillates from 0-21, indicating higher scores to greater severity of the IU.
    Time Frame
    baseline,3 months, 6 months
    Title
    Treatment satisfaction
    Description
    Visual analogic scale (VAS, 0-10, 0=minimum score, 10=maximum score). Higher values represent a better outcome (less treatment satisfaction)
    Time Frame
    3 months
    Title
    Changes from IU impact. KHQ
    Description
    Question nº2 of KHQ measured IU impact in patient's life. Is a Likert scale 0-4 punctuation ( 0= no proceed, 4= A lot)
    Time Frame
    baseline,3 months, 6 months
    Title
    Changes from IU impact.ICIQ-IU-SF
    Description
    Question nº3 of ICIQ-IU-SF, measured IU impact in patient's life.Is a numeric scale (1-10),(1= none and 10= a lot )
    Time Frame
    Initial,3 months, 6 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    45-75 years and hormonal state
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: SUI or stress-predominant mixed UI diagnosed via clinical assessment and urodynamic study Estrogenic deficit.: perimenopause, menopause, postmenopause Exclusion Criteria: grade 3-4 prolapse, functional alterations (Barthel Scale > 85 points), neurological or cognitive alterations (mini mental examination > 24 points) other predominant type of urinary incontinence.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The fist idea was make a Doctoral Thesis. But the investigators continue investigating in this area.
    Citations:
    Citation
    1. Salinas Casado J, Díaz Rodríguez A, Brenes Bermúdez F, Cancelo Hidalgo MJ, Cuenllas Díaz A, Verdejo Bravo C. Prevalencia de la incontinencia urinaria en España. UROD A. 2010; 23 (1): 52-66. 2. Aguilar-Navarro SG, Incontinencia urinaria en el adulto mayor. Rev Enferm Inst Mex Seguro Soc. 2007; 15 (1): 51-56. 3. Zunzunegui Pastor MV, Rodríguez Laso A, García de Yébenes MJ, Aguilar Conesa M.D, Lázaro y de Mercado P y Otero Puime A. Prevalencia de la incontinencia urinaria y factores asociados en varones y mujeres de más de 65 años. Aten Primaria. 2003; 32 (6): 337-342. 4. Grosse D, Sengler J. Reeducación del periné fisioterapia en las incontinencias urinarias. Ed Masson. 2001. 5. Robles JE (editor). I Curso de formación en incontinencia urinaria. Pamplona: Newbook ediciones. 2001. 6. Guía clínica sobre la incontinencia urinaria. Schroder A, Abrams P. Andersson KE, Artibani W, Chapple CR, Drake MJ, Hampel C, Neisius A, Tubaro A, Thuroff JW. European Association of Urology. 2010. 7. Lacima G, Espuña M. Patología del suelo pélvico. Gastroenterol Hepatol. 2008; 31 (9): 587-595. 8. Sapsford R. The pelvic floor. A clinical model for function and rehabilitation. Physiotherapy. 2001; 87 (12): 620-630.
    Results Reference
    background

    Learn more about this trial

    Posture in Abdominopelvic Training in Women SUI

    We'll reach out to this number within 24 hrs