Stress Urinary IncontinenceNCT03825653
Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopausal Women
An observational study of Stress Urinary Incontinence, run by Cairo University.
Trial summary
This study will be conducted to assess biomechanical alignment of lower limb as a predictor for the stress urinary incontinence in the postmenopausal women. 300 postmenopausual women will be selected suffering from stress unrinary incontinence . Their age ranges from 60 to 70 years old. Read more about this study
- Who is it for?
- Ages 60 to 70 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 29 Jan 2019to Feb 2020
- 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 60 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 300 postmenopausal women suffering from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2
Who may be able to join
- Subjects will be 300 postmenopausal women suffering from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2
Who cannot join
- previous history of cancer and radiotherapy, any disease that could interfere with the participation, lower urinary tract infections( Manshadi F. etal ) musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases; diabetes mellitus, a body mass index >30 kg/m2; intraureterine device implantation, pelvic organ prolapse and menopause (Cerruto M etal.)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopasual Women
This study will be conducted to assess biomechanical alignment of lower limb as a predictor for the stress urinary incontinence in the postmenopausal women. 300 postmenopausual women will be selected suffering from stress unrinary incontinence . Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2.
Read the detailed description
in this study 300 postmenopausual women will be selected suffering from stress unrinary incontinence. Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2. different methods of assessment will be used as : Data recording sheet, Weight-Height scale, Goniometer ,x ray radiography ,Transabdominal ultrasound and Perineal ultrasound. Data recording sheet: It will be used to record data of each woman before starting this study. Weight-Height scale: It will be used to measure weight and height of each woman before starting this study. Goniometer: it will be used to document the initial and the subsequent range of motion for ankle joint for each woman. Transabdominal ultrasound: it will be used for measurement of Post-void residual volume PVR for each woman which is the volume of urine left in the bladder after micturition . Perineal ultrasound: it will be used to assess the posterior urethrovesical angle for each woman . X-ray radiography: lateral pelvic radiographs will be taken for each woman in order to objectify the individual pelvic tilt. Inclusion criteria include : Subjects will be postmenopausal women complaining from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2. Exclusion criteria: previous history of cancer and radiotherapy, any disease that could interfere with the participation, lower urinary tract infections( Manshadi F. etal ) musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases; diabetes mellitus, a body mass index >30 kg/m2; intraureterine device implantation, pelvic organ prolapse and menopause (Cerruto M etal.)
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, pelvic tilt, ankle position
- 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.
| Study group | Role | What they receive |
|---|---|---|
| one group | This study will be carried out on three hundred postmenopausal.They will be selected from gynecological outpatient clinic of (Oum El Masryn Hospital). their age will range from 60-70 years.Their BMI will not exceed 30 kg/m2. They are complaining from stress urinary incontinence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-void residual volume PVR
Transabdominal ultrasound
it will be used for measurement of Post-void residual volume PVR for each woman which is the volume of urine left in the bladder after micturition
Measured: 30 minutes for every patient
posterior urethrovesical angle
perineal ultrasound will be used to assesse the posterior urethrovesical angle for each woman
Measured: 30 minutes for every patient
pelvic tilt
lateral pelvic radiographic xray will be taken for each woman in order to objectify the individual pelvic tilt
Measured: 30 minutes for every patient
Secondary outcomes (2)
ankle range of motion
goniometer will be used to measure the range of motion for ankle joint
Measured: 10 minutes for every patient
BMI
weight height scale will be used to measure weight and height of each woman before starting this study
Measured: 10 minutes for every patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start29 Jan 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAhmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825653
- Sponsor's protocol ID
- P.T.REC/012/001885
- Status last verified
- Dec 2018
- First submitted
- 30 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopasual Women
- ClinicalTrials.gov ID
- NCT03825653
- Acronym / sponsor ID
- P.T.REC/012/001885
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, pelvic tilt, ankle position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Jan 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 31 Jan 2019 (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.
This study will be conducted to assess biomechanical alignment of lower limb as a predictor for the stress urinary incontinence in the postmenopausal women. 300 postmenopausual women will be selected suffering from stress unrinary incontinence . Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2.
Detailed description
in this study 300 postmenopausual women will be selected suffering from stress unrinary incontinence. Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2. different methods of assessment will be used as : Data recording sheet, Weight-Height scale, Goniometer ,x ray radiography ,Transabdominal ultrasound and Perineal ultrasound. Data recording sheet: It will be used to record data of each woman before starting this study. Weight-Height scale: It will be used to measure weight and height of each woman before starting this study. Goniometer: it will be used to document the initial and the subsequent range of motion for ankle joint for each woman. Transabdominal ultrasound: it will be used for measurement of Post-void residual volume PVR for each woman which is the volume of urine left in the bladder after micturition . Perineal ultrasound: it will be used to assess the posterior urethrovesical angle for each woman . X-ray radiography: lateral pelvic radiographs will be taken for each woman in order to objectify the individual pelvic tilt. Inclusion criteria include : Subjects will be postmenopausal women complaining from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2. Exclusion criteria: previous history of cancer and radiotherapy, any disease that could interfere with the participation, lower urinary tract infections( Manshadi F. etal ) musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases; diabetes mellitus, a body mass index >30 kg/m2; intraureterine device implantation, pelvic organ prolapse and menopause (Cerruto M etal.)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | – | –This study will be carried out on three hundred postmenopausal.They will be selected from gynecological outpatient clinic of (Oum El Masryn Hospital). their age will range from 60-70 years.Their BMI will not exceed 30 kg/m2. They are complaining from stress urinary incontinence. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 postmenopausal women suffering from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2
Key inclusion criteria (1 listed)
- Subjects will be 300 postmenopausal women suffering from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2
Key exclusion criteria (1 listed)
- previous history of cancer and radiotherapy, any disease that could interfere with the participation, lower urinary tract infections( Manshadi F. etal ) musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases; diabetes mellitus, a body mass index >30 kg/m2; intraureterine device implantation, pelvic organ prolapse and menopause (Cerruto M etal.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-void residual volume PVR
Time frame: 30 minutes for every patient
Transabdominal ultrasound it will be used for measurement of Post-void residual volume PVR for each woman which is the volume of urine left in the bladder after micturition
posterior urethrovesical angle
Time frame: 30 minutes for every patient
perineal ultrasound will be used to assesse the posterior urethrovesical angle for each woman
pelvic tilt
Time frame: 30 minutes for every patient
lateral pelvic radiographic xray will be taken for each woman in order to objectify the individual pelvic tilt
2 secondary outcomes
ankle range of motion
Time frame: 10 minutes for every patient
BMI
Time frame: 10 minutes for every patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Cairo University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yara n zaki, M sc. (01010446044, ynz.yara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-void residual volume PVR (time frame: 30 minutes for every patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2019.