Urinary Stress IncontinenceNCT04288648
Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
An observational study of Urinary Stress Incontinence, run by University of Haifa at 1 site in Israel.
Trial summary
Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- ultrasound examination
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- 17 May 2020to 1 Nov 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women, between ages 18-45 with and without USI.
Who may be able to join
- willing to participate in the study
- being able to squat for over 10 seconds.
- inclusion for study group - participants suffering from SUI that received a grade>0 in sections 3+4 (how frequent does urinary leakage appear, the amount of urine leakage and does the participant use pads for leakage absorption) and a grade>0 in section 5 (how much does SUI interrupt the participant's daily life) in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).
- Inclusion for control group - healthy participants (grade 0 in the ICIQ- SF questionnaire).
Who cannot join
- Other types of urinary leakage
- receiving pelvic floor treatments in the past or present
- active urinary or vaginal infections
- neurological diseases
- urologic, gynecologic or abdominal surgery
- pelvic organ prolapse
Show all 10Show fewer
- pregnancy
- chronic cough
- constipation
- unbalanced diabetes and the use of medication that affects urination
Trial locations and contacts
1 site in 1 country.
About this study
Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment.
Read the detailed description
The main goal of this study is to compare the ability of the pelvic floor muscles to contract in different positions among women suffering from SUI to healthy women. Secondary objectives: is to compare subjective reports of the difficulty to contract the pelvic floor muscles between the two groups, and to examine the connection between the severity of urinary leakage and the ability to contract pelvic floor muscles.
The study will include 50 female participants in the ages of 18-45. Research group will include 25 participants suffering from SUI in accordance with the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and 25 healthy participants (grade 0 on the ICIQ-SF questionnaire).
The examination will be performed with an abdominal ultrasound device in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. The extent and direction of bladder base movement would indicate the quality of pelvic floor performance. Next, the length of contraction time will be measured. The participant would hold the maximal contraction as long as possible in order to examine muscular endurance. Rest will be given between tests. After finishing the tests in all four postures, the participants will be questioned about the degree of difficulty contracting the pelvic floor.
Significance of the study: The importance of the research is about granting the clinicians and researchers additional tools in order to help establishing a protocol for pelvic floor muscle activity examination and treatment.
- Conditions
- Urinary Stress Incontinence
- Being tested
- ultrasound examination
- 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.
ultrasound examinationDiagnostic test
Also called transabdominal ultrasound assessment
ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.
| Study group | Role | What they receive |
|---|---|---|
| SUI group | Examination will include an abdominal ultrasound assessment of pelvic floor muscle in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. Receives: Diagnostic Test: ultrasound examination | |
| control group | Examination will include an abdominal ultrasound assessment of pelvic floor muscle in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. Receives: Diagnostic Test: ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
direction of urinary bladder displacement during contraction
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
Measured: baseline
Secondary outcomes (3)
urinary bladder displacement in millimeters
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Measured: baseline
pelvic floor muscles endurance of contraction in seconds
time of muscle contraction will be measured during the last contraction
Measured: baseline
questioned about the degree of difficulty contracting the pelvic floor.
Each participant will grade on a scale of 1-10 (10 most difficult) the subjective difficulty of contraction in each position
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start17 May 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
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 Stress IncontinenceStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 42 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gali Dar, University of Haifa
- Investigators
- Gali Dar, PhD, Principal investigator, Gali Dar, Department of Physical Therapy, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288648
- Sponsor's protocol ID
- HU 26/2020
- Status last verified
- Nov 2021
- First submitted
- 26 Feb 2020
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: following study completion, a paper will be submitted to international professional journal
Publications
Sapsford RR, Richardson CA, Stanton WR. Sitting posture affects pelvic floor muscle activity in parous women: an observational study. Aust J Physiother. 2006;52(3):219-22. doi: 10.1016/s0004-9514(06)70031-9.
PubMed 16942457
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04288648
- Acronym / sponsor ID
- HU 26/2020
- Conditions
- Urinary Stress Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 17 May 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 28 Feb 2020 (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.
Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment.
Detailed description
The main goal of this study is to compare the ability of the pelvic floor muscles to contract in different positions among women suffering from SUI to healthy women. Secondary objectives: is to compare subjective reports of the difficulty to contract the pelvic floor muscles between the two groups, and to examine the connection between the severity of urinary leakage and the ability to contract pelvic floor muscles.
The study will include 50 female participants in the ages of 18-45. Research group will include 25 participants suffering from SUI in accordance with the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and 25 healthy participants (grade 0 on the ICIQ-SF questionnaire).
The examination will be performed with an abdominal ultrasound device in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. The extent and direction of bladder base movement would indicate the quality of pelvic floor performance. Next, the length of contraction time will be measured. The participant would hold the maximal contraction as long as possible in order to examine muscular endurance. Rest will be given between tests. After finishing the tests in all four postures, the participants will be questioned about the degree of difficulty contracting the pelvic floor.
Significance of the study: The importance of the research is about granting the clinicians and researchers additional tools in order to help establishing a protocol for pelvic floor muscle activity examination and treatment.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUI group | – | Diagnostic Test: ultrasound examinationExamination will include an abdominal ultrasound assessment of pelvic floor muscle in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. |
| control group | – | Diagnostic Test: ultrasound examinationExamination will include an abdominal ultrasound assessment of pelvic floor muscle in supine, sitting, standing and squatting. The Height of the bladder base will be measured during rest period and maximal contraction. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women, between ages 18-45 with and without USI.
Key inclusion criteria (4 listed)
- willing to participate in the study
- being able to squat for over 10 seconds.
- inclusion for study group - participants suffering from SUI that received a grade>0 in sections 3+4 (how frequent does urinary leakage appear, the amount of urine leakage and does the participant use pads for leakage absorption) and a grade>0 in section 5 (how much does SUI interrupt the participant's daily life) in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).
- Inclusion for control group - healthy participants (grade 0 in the ICIQ- SF questionnaire).
Key exclusion criteria (10 listed)
- Other types of urinary leakage
- receiving pelvic floor treatments in the past or present
- active urinary or vaginal infections
- neurological diseases
- urologic, gynecologic or abdominal surgery
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 |
|---|---|---|
| ultrasound examinationAlso: transabdominal ultrasound assessmentultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed. | Diagnostic test | SUI group, control group |
Primary outcome
direction of urinary bladder displacement during contraction
Time frame: baseline
upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound
3 secondary outcomes
urinary bladder displacement in millimeters
Time frame: baseline
pelvic floor muscles endurance of contraction in seconds
Time frame: baseline
questioned about the degree of difficulty contracting the pelvic floor.
Time frame: baseline
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 15 Nov 2021.
- Results publication: PubMed 16942457Sapsford RR, Richardson CA, Stanton WR. Sitting posture affects pelvic floor muscle activity in parous women: an observational study. Aust J Physiother. 2006;52(3):219-22. doi: 10.1016/s0004-9514(06)70031-9.
- Individual participant dataSharing planned: Yes. following study completion, a paper will be submitted to international professional journal
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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.
Gali Dar, PhD principal investigator
Gali Dar, Department of Physical Therapy, University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Stress Incontinence, run by University of Haifa at 1 site in Israel.
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 4 inclusion and 10 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 15 Nov 2021. 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 Israel. 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?
direction of urinary bladder displacement during contraction (time frame: baseline). 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 NCT04288648, 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 15 Nov 2021.