The Knack on Female Stress Urinary Incontinence

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    210
  • sponsor
    Federal University of São Paulo
Updated on 16 February 2022
incontinence
urinary symptoms
pelvic floor muscle training
home exercises
bladder diary
leakage of urine
Accepts healthy volunteers

Summary

The aim of the present study is to test the hypothesis that voluntary pelvic floor muscle pre-contraction (the Knack) (alone) can be a treatment for urine leakage during efforts. For this purpose, the following parameters will be analysed and compared amongst 1) the Knack, 2) pelvic floor muscle training and 3) the Knack + pelvic floor muscle training groups: urine leakage as assessed by the pad test, urinary symptoms, muscle function, quality of life, subjective cure, adherence to exercises in the outpatient setting and at home and perceived self-efficacy of pelvic floor muscle exercises.

The study population will comprise women with mild to moderate stress urinary incontinence or mixed urinary incontinente (with predominant stress urinary incontinence) as assessed by means of the one-hour pad test (leakage 2 g). Leakage up to 10 grams will be rated mild stress urinary incontinence and of 11 to 50 grams as moderate stress urinary incontinence. The sample will also include women with grade 2 muscle strength (normal contraction with elevation of the anterior vaginal wall) on the two-finger assessment rated according to the Oxford scale.

The primary outcome measure will be the objective cure of urinary incontinence as assessed by means of the one-hour pad test three months after randomization.

Secondary outcome measures: three-day bladder diary, 1 hour pad test, International Consultation on Incontinence Questionnaire - Short Form, Incontinence Quality of Life Questionnaire, Subjective cure of stress urinary incontinence, Self-efficacy/outcome expectation to pelvic floor muscle exercises, Frequency of the outpatient sessions, adherence to home exercises and pelvic floor muscle function, morphometry, strength and vaginal squeeze pressure.

Details
Condition Urinary Incontinence, Stress
Treatment the Knack, PFMT, The Knack + PFMT
Clinical Study IdentifierNCT03722719
SponsorFederal University of São Paulo
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Mild to moderate stress urinary incontinence or mixed urinary incontinence (with predominance of stress urinary incontinence) as assessed by means of the one-hour pad test (leakage 2 g). Mild stress urinary incontinence will be defined as leakage up to 10 g and moderate stress urinary incontinence as leakage of 11 to 50 g
Able to have a gynaecological examination

Exclusion Criteria

Symptoms of overactive bladder alone
Chronic degenerative, uncontrolled metabolic, neurological or psychiatric diseases
Previous participation in a pelvic floor re-education programe and/or previous pelvic floor surgery or currently receiving other treatment for urinary incontinence
Pelvic organ prolapse greater than stage II according to the Pelvic Organ Prolapse Quantification (POP-Q) system
Use of medication for urinary incontinence or medication that interferes with the musculoskeletal system
Loss of stools or mucus
Active urinary or vaginal infection in the past three months
Body mass index 35 Kg/m2
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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