Urinary Incontinence, StressNCT03722719
The Knack on Female Stress Urinary Incontinence
A study testing the Knack, PFMT and The Knack + PFMT in people with Urinary Incontinence, Stress, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- the Knack, PFMT and The Knack + PFMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2018to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Voluntary Pre-contraction of the Pelvic Floor Muscles (the Knack) on Female Stress Urinary Incontinence - Randomised Controlled Clinical Trial
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.
Read more
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
- Being tested
- the Knack, PFMT, The Knack + PFMT
- Keywords
- Urinary Incontinence, Stress, Physical Therapy Modalities
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the KnackOther
Also called Voluntary PFM pre-contraction
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.
PFMTOther
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.
The Knack + PFMTOther
These participants will perform the exercises described for both the Knack and PFMT groups at the outpatient clinic and at home.
| Study group | Role | What they receive |
|---|---|---|
| Group I (the Knack) | Experimental | Not described Receives: Other: the Knack |
| Group II (PFMT) | Active comparator | Not described Receives: Other: PFMT |
| Group III (the Knack + PFMT) | Active comparator | Not described Receives: Other: The Knack + PFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-hour pad test
The objective cure of urine loss after intervention will be defined as leakage <2 grams.
Measured: 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
This validated instrument assesses daytime/night-time urine leakage episodes during three consecutive days.
Measured: Three and six after months after randomization.
One-hour pad test.
This test assesses urine leakage (in grams) in situations involving effort.
Measured: Three and six after months after randomization.
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).
Measured: Three and six after months after randomization.
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.
Measured: Three and six after months after randomization.
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.
Measured: Three and six after months after randomization.
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.
Measured: After three and six months of treatment.
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.
Measured: Three and six after months after randomization.
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.
Measured: After three and six months of treatment.
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.
Measured: After three and six months of treatment.
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.
Measured: After three and six months of treatment.
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.
Measured: After three and six months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Nov 2018
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Fitz, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722719
- Sponsor's protocol ID
- 003
- Status last verified
- Mar 2024
- First submitted
- 21 Oct 2018
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34301324
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Voluntary Pre-contraction of the Pelvic Floor Muscles (the Knack) on Female Stress Urinary Incontinence - Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03722719
- Acronym / sponsor ID
- 003
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Urinary Incontinence, Stress, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the KnackAlso: Voluntary PFM pre-contractionThe 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. | Other | Group I (the Knack) |
| PFMTThe 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. | Other | Group II (PFMT) |
| The Knack + PFMTThese participants will perform the exercises described for both the Knack and PFMT groups at the outpatient clinic and at home. | Other | Group III (the Knack + PFMT) |
Primary outcome
One-hour pad test
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.
The objective cure of urine loss after intervention will be defined as leakage <2 grams.
11 secondary outcomes
Three-day bladder diary
Time frame: Three and six after months after randomization.
One-hour pad test.
Time frame: Three and six after months after randomization.
International Consultation on Incontinence Questionnaire - Short Form.
Time frame: Three and six after months after randomization.
Incontinence Quality of Life Questionnaire.
Time frame: Three and six after months after randomization.
Subjective cure of stress urinary incontinence.
Time frame: Three and six after months after randomization.
Frequency of the outpatient sessions
Time frame: After three and six months of treatment.
Self-efficacy/outcome expectation to pelvic floor muscle exercises
Time frame: Three and six after months after randomization.
Pelvic floor muscle function
Time frame: After three and six months of treatment.
Pelvic floor muscle morphometry
Time frame: After three and six months of treatment.
Pelvic floor muscle strength
Time frame: After three and six months of treatment.
Vaginal squeeze pressure
Time frame: After three and six months of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 34301324Fitz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Knack, PFMT and The Knack + PFMT in people with Urinary Incontinence, Stress, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-hour pad test (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.