Clinical trial NCT03727945: Posture in Abdominopelvic Training in Women SUI
Official title: Posture Correction in Abdominopelvic Training in Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Stress Incontinence
Keywords: stress urinary incontinence
abdominopelvic exercise
quality of life
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 49
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 aleatorized groups; control group (n=21) and intervention group
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Changes from Quality of life. KHQ
timeFrame: baseline,3 months,6 months
measure: Changes from Quality of life. ICIQ-IU-SF
timeFrame: baseline,3 months, 6 months
measure: Treatment satisfaction
timeFrame: 3 months
measure: Changes from IU impact. KHQ
timeFrame: baseline,3 months, 6 months
measure: Changes from IU impact.ICIQ-IU-SF
timeFrame: Initial,3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.