The Knack on Female Stress Urinary Incontinence

NCT03722719 | Completed

• 1 other identifier: 003
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Stress

Keywords

Urinary Incontinence, Stress; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• One-hour pad test

  The objective cure of urine loss after intervention will be defined as leakage \<2 grams.

  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 (11)

• Three-day bladder diary

  Three and six after months after randomization.

• One-hour pad test.

  Three and six after months after randomization.

• International Consultation on Incontinence Questionnaire - Short Form.

  Three and six after months after randomization.

• Incontinence Quality of Life Questionnaire.

  Three and six after months after randomization.

• Subjective cure of stress urinary incontinence.

  Three and six after months after randomization.

Study Arms (3)

Group I (the Knack)

EXPERIMENTAL

Other: the Knack

Group II (PFMT)

ACTIVE COMPARATOR

Other: PFMT

Group III (the Knack + PFMT)

ACTIVE COMPARATOR

Other: The Knack + PFMT

Interventions

the Knack OTHER

The Knack consists of voluntary PFM contractions before and during activities that increase abdominal pressure. Such contraction elevates the pelvic floor cranially, with consequent closure of the urethra, vagina and rectum, stabilization of the pelvic floor and avoidance of urine leakage.

Also known as: Voluntary PFM pre-contraction

Group I (the Knack)

PFMT OTHER

The rationale underlying intensive PFM strength training is that it might develop the structural support of the pelvis by raising the levator plate to a permanent, higher position within the pelvis and promoting PFM and connective tissue hypertrophy and stiffness. These conditions facilitate automatic and more efficacious activation of motor units (neural adaptation), which impedes descent during activities that increase abdominal pressure.

Group II (PFMT)

The Knack + PFMT OTHER

These participants will perform the exercises described for both the Knack and PFMT groups at the outpatient clinic and at home.

Group III (the Knack + PFMT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, 04024-002, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34301324 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 29, 2018
• Study Start: November 1, 2018
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

BR (1)