NCT03727945

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

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

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 28, 2018

Last Update Submit

October 31, 2018

Conditions

Keywords

stress urinary incontinenceabdominopelvic exercisequality of life

Outcome Measures

Primary Outcomes (5)

  • 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)

    baseline,3 months,6 months

  • 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.

    baseline,3 months, 6 months

  • Treatment satisfaction

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

    3 months

  • 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)

    baseline,3 months, 6 months

  • 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 )

    Initial,3 months, 6 months

Study Arms (2)

abdominopelvic exercise and posture

EXPERIMENTAL

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

Other: abdominopelvic exercise and posture

abdominopelvic exercise

EXPERIMENTAL

N=21 received supervised physiotherapy abdominopelvic exercise.

Other: abdominopelvic exercise

Interventions

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.

abdominopelvic exercise and posture

n=21 women received supervised abdominopelvic exercise. During 12 sessions a specialized physiotherapist supervised to realization of progressive abdominopelvic exercises.

abdominopelvic exercise

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details45-75 years and hormonal state
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Posture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Urolog was not involved in physiotherapy treatment, randomised patients previous of treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 aleatorized groups; control group (n=21) and intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Professor

Study Record Dates

First Submitted

October 28, 2018

First Posted

November 1, 2018

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

November 1, 2018

Record last verified: 2018-10