QoL SUI: Posture in Abdominopelvic Training in Women SUI

• Sponsor: University of Valencia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03727945
• Collaborator: (none)
• Enrollment: 49
• Arms: 2
• Actual Duration (Months): 24

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Female Stress Incontinence	Other: abdominopelvic exercise and posture; Other: abdominopelvic exercise	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2 aleatorized groups; control group (n=21) and intervention group2 aleatorized groups; control group (n=21) and intervention group
• Masking: Single (Participant)
• Masking Description: Urolog was not involved in physiotherapy treatment, randomised patients previous of treatment.
• Primary Purpose: Treatment
• Official Title: Posture Correction in Abdominopelvic Training in Women With Stress Urinary Incontinence
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: abdominopelvic exercise and posture N=21 received supervised physiotherapy abdominopelvic exercise previous postural correction.	Other: abdominopelvic exercise and posture; 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.
Experimental: abdominopelvic exercise N=21 received supervised physiotherapy abdominopelvic exercise.	Other: abdominopelvic exercise; n=21 women received supervised abdominopelvic exercise. During 12 sessions a specialized physiotherapist supervised to realization of progressive abdominopelvic exercises.

Outcome Measures

Primary Outcome Measures

1. Changes from Quality of life. KHQ [baseline,3 months,6 months]

   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)

2. Changes from Quality of life. ICIQ-IU-SF [baseline,3 months, 6 months]

   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.

3. Treatment satisfaction [3 months]

   Visual analogic scale (VAS, 0-10, 0=minimum score, 10=maximum score). Higher values represent a better outcome (less treatment satisfaction)

4. Changes from IU impact. KHQ [baseline,3 months, 6 months]

   Question nº2 of KHQ measured IU impact in patient's life. Is a Likert scale 0-4 punctuation ( 0= no proceed, 4= A lot)

5. Changes from IU impact.ICIQ-IU-SF [Initial,3 months, 6 months]

   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 )

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Laura Fuentes Aparicio, PhD Professor, University of Valencia
• ClinicalTrials.gov Identifier: NCT03727945
• Other Study ID Numbers: H1410616852782,
• First Posted: Nov 1, 2018
• Last Update Posted: Nov 1, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Laura Fuentes Aparicio, PhD Professor, University of Valencia: stress urinary incontinence; abdominopelvic exercise; quality of life
• Additional relevant MeSH terms: Urinary Incontinence, Stress

Study Results

No Results Posted as of Nov 1, 2018