Clinical trial NCT03825653: Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopausal Women
Official title: Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopasual Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
pelvic tilt
ankle position
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.)

Eligibility criteria: Inclusion Criteria:

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

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.)

Primary outcomes:
measure: Post-void residual volume PVR
timeFrame: 30 minutes for every patient
measure: posterior urethrovesical angle
timeFrame: 30 minutes for every patient
measure: pelvic tilt
timeFrame: 30 minutes for every patient
Secondary outcomes:
measure: ankle range of motion
timeFrame: 10 minutes for every patient
measure: BMI
timeFrame: 10 minutes for every patient
Other outcomes:
Locations:
Study officials:
References: