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
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
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
NCT ID
NCT03727945
First Posted
October 28, 2018
Last Updated
October 31, 2018
Sponsor
University of Valencia
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
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Posture in Abdominopelvic Training in Women SUI
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