Clinical trial NCT03722719: The Knack on Female Stress Urinary Incontinence
Official title: Effects of Voluntary Pre-contraction of the Pelvic Floor Muscles (the Knack) on Female Stress Urinary Incontinence - Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Keywords: Urinary Incontinence, Stress
Physical Therapy Modalities
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: One-hour pad test
timeFrame: 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 outcomes:
measure: Three-day bladder diary
timeFrame: Three and six after months after randomization.
measure: One-hour pad test.
timeFrame: Three and six after months after randomization.
measure: International Consultation on Incontinence Questionnaire - Short Form.
timeFrame: Three and six after months after randomization.
measure: Incontinence Quality of Life Questionnaire.
timeFrame: Three and six after months after randomization.
measure: Subjective cure of stress urinary incontinence.
timeFrame: Three and six after months after randomization.
measure: Frequency of the outpatient sessions
timeFrame: After three and six months of treatment.
measure: Self-efficacy/outcome expectation to pelvic floor muscle exercises
timeFrame: Three and six after months after randomization.
measure: Pelvic floor muscle function
timeFrame: After three and six months of treatment.
measure: Pelvic floor muscle morphometry
timeFrame: After three and six months of treatment.
measure: Pelvic floor muscle strength
timeFrame: After three and six months of treatment.
measure: Vaginal squeeze pressure
timeFrame: After three and six months of treatment.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
References:
citation: Fitz FF, Gimenez MM, de Azevedo Ferreira L, Matias MMP, Bortolini MAT, Castro RA. Effects of voluntary pre-contraction of the pelvic floor muscles (the Knack) on female stress urinary incontinence-a study protocol for a RCT. Trials. 2021 Jul 23;22(1):484. doi: 10.1186/s13063-021-05440-0.