The Knack on Female Stress Urinary Incontinence
Primary Purpose
Urinary Incontinence, Stress
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
the Knack
PFMT
The Knack + PFMT
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring Urinary Incontinence, Stress, Physical Therapy Modalities
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
Sites / Locations
- Universidade Federal de São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Group I (the Knack)
Group II (PFMT)
Group III (the Knack + PFMT)
Arm Description
Outcomes
Primary Outcome Measures
One-hour pad test
The objective cure of urine loss after intervention will be defined as leakage <2 grams.
Secondary Outcome Measures
Three-day bladder diary
This validated instrument assesses daytime/night-time urine leakage episodes during three consecutive days.
One-hour pad test.
This test assesses urine leakage (in grams) in situations involving effort.
International Consultation on Incontinence Questionnaire - Short Form.
A four-item questionnaire that evaluates the impact of symptoms of incontinence on quality of life and outcome of treatment (0-21 overall score, with greater values indicating increased severity).
Incontinence Quality of Life Questionnaire.
The impact of stress urinary incontinence on quality of life will be assessed by the Incontinence Quality-of-Life Questionnaire. The Incontinence Quality-of-Life Questionnaire evaluates the limitations on human behaviour, psychosocial impact and social embarrassment. The score ranges from 0 to 100 points, and the lower the score, the greater the impact of urinary incontinence on the patient's quality of life.
Subjective cure of stress urinary incontinence.
The subjective cure will be measured by asking the patients if they were "satisfied" or "dissatisfied" about their condition (urinary incontinence) after treatment. The investigators considered them to be "satisfied" when the patient was happy with the results and did not want a different treatment and "dissatisfied" if the patient desired a treatment other than the initial one.
Frequency of the outpatient sessions
The number of completed exercise sets will be obtained using an exercise diary, and it will be recorded as the mean of the exercise sets per month performed during the three-month therapy intervention for both groups and the number of home exercise sets in both groups will also be assessed at the six-month follow-up.
Self-efficacy/outcome expectation to pelvic floor muscle exercises
The scale contains 17 questions in the format of a visual analogue scale with answers ranging from 0 (not confident at all) to 100 (the most confident). Thirteen items refer to self-efficacy and four to outcome expectations. The final scores will be obtained by calculating the mean of the items, ranging from 0 to 100, in which higher values are equivalent to more beneficial self-efficacy/outcome expectation to pelvic floor muscle exercises.
Pelvic floor muscle function
Pelvic floor muscle function - assessed through two-finger vaginal palpation. The muscular performance will be graded for Oxford grade scale in 4 levels (0-3): Degree 0 - absent contraction; and Grade 3 - Strong contraction.
Pelvic floor muscle morphometry
The following measurements will be performed: bladder neck mobility, hiatal area, constriction of the levator hiatus (anteroposterior and transverse lengths of hiatus) and pubovisceral muscle thickness.
Pelvic floor muscle strength
The vaginal dynamometer will measure resistance to unidirectional and anteroposterior compression in kilograms/force (kgf). The participants will be requested to perform three maximum voluntary contractions. The best of the three will be registered.
Vaginal squeeze pressure
Vaginal balloon catheter will be used to assess the vaginal squeeze pressure (in cmH20). The best of three consecutive attempts will be registered as the maximum voluntary contractions.
Full Information
NCT ID
NCT03722719
First Posted
October 21, 2018
Last Updated
September 13, 2023
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03722719
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
Urinary Incontinence, Stress, Physical Therapy Modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I (the Knack)
Arm Type
Experimental
Arm Title
Group II (PFMT)
Arm Type
Active Comparator
Arm Title
Group III (the Knack + PFMT)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
the Knack
Other Intervention Name(s)
Voluntary PFM pre-contraction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PFMT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The Knack + PFMT
Intervention Description
These participants will perform the exercises described for both the Knack and PFMT groups at the outpatient clinic and at home.
Primary Outcome Measure Information:
Title
One-hour pad test
Description
The objective cure of urine loss after intervention will be defined as leakage <2 grams.
Time Frame
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 Measure Information:
Title
Three-day bladder diary
Description
This validated instrument assesses daytime/night-time urine leakage episodes during three consecutive days.
Time Frame
Three and six after months after randomization.
Title
One-hour pad test.
Description
This test assesses urine leakage (in grams) in situations involving effort.
Time Frame
Three and six after months after randomization.
Title
International Consultation on Incontinence Questionnaire - Short Form.
Description
A four-item questionnaire that evaluates the impact of symptoms of incontinence on quality of life and outcome of treatment (0-21 overall score, with greater values indicating increased severity).
Time Frame
Three and six after months after randomization.
Title
Incontinence Quality of Life Questionnaire.
Description
The impact of stress urinary incontinence on quality of life will be assessed by the Incontinence Quality-of-Life Questionnaire. The Incontinence Quality-of-Life Questionnaire evaluates the limitations on human behaviour, psychosocial impact and social embarrassment. The score ranges from 0 to 100 points, and the lower the score, the greater the impact of urinary incontinence on the patient's quality of life.
Time Frame
Three and six after months after randomization.
Title
Subjective cure of stress urinary incontinence.
Description
The subjective cure will be measured by asking the patients if they were "satisfied" or "dissatisfied" about their condition (urinary incontinence) after treatment. The investigators considered them to be "satisfied" when the patient was happy with the results and did not want a different treatment and "dissatisfied" if the patient desired a treatment other than the initial one.
Time Frame
Three and six after months after randomization.
Title
Frequency of the outpatient sessions
Description
The number of completed exercise sets will be obtained using an exercise diary, and it will be recorded as the mean of the exercise sets per month performed during the three-month therapy intervention for both groups and the number of home exercise sets in both groups will also be assessed at the six-month follow-up.
Time Frame
After three and six months of treatment.
Title
Self-efficacy/outcome expectation to pelvic floor muscle exercises
Description
The scale contains 17 questions in the format of a visual analogue scale with answers ranging from 0 (not confident at all) to 100 (the most confident). Thirteen items refer to self-efficacy and four to outcome expectations. The final scores will be obtained by calculating the mean of the items, ranging from 0 to 100, in which higher values are equivalent to more beneficial self-efficacy/outcome expectation to pelvic floor muscle exercises.
Time Frame
Three and six after months after randomization.
Title
Pelvic floor muscle function
Description
Pelvic floor muscle function - assessed through two-finger vaginal palpation. The muscular performance will be graded for Oxford grade scale in 4 levels (0-3): Degree 0 - absent contraction; and Grade 3 - Strong contraction.
Time Frame
After three and six months of treatment.
Title
Pelvic floor muscle morphometry
Description
The following measurements will be performed: bladder neck mobility, hiatal area, constriction of the levator hiatus (anteroposterior and transverse lengths of hiatus) and pubovisceral muscle thickness.
Time Frame
After three and six months of treatment.
Title
Pelvic floor muscle strength
Description
The vaginal dynamometer will measure resistance to unidirectional and anteroposterior compression in kilograms/force (kgf). The participants will be requested to perform three maximum voluntary contractions. The best of the three will be registered.
Time Frame
After three and six months of treatment.
Title
Vaginal squeeze pressure
Description
Vaginal balloon catheter will be used to assess the vaginal squeeze pressure (in cmH20). The best of three consecutive attempts will be registered as the maximum voluntary contractions.
Time Frame
After three and six months of treatment.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fátima F Fitz, PhD
Phone
+5511999651084
Email
fanifitz@yahoo.com.br
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatima Fitz, PhD
Phone
11999651084
Email
fanifitz@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Fatima Fitz
Phone
11999651084
Email
fanifitz@yahoo.com.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34301324
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.
Results Reference
derived
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The Knack on Female Stress Urinary Incontinence
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