Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopausal Women

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT03825653
• Lead Sponsor: Cairo University

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.)

Study Timeline

• Status Verified: 2018-12
• Study Start: 2019-01-29
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
posterior urethrovesical angle	30 minutes for every patient	perineal ultrasound will be used to assesse the posterior urethrovesical angle for each woman
Post-void residual volume PVR	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
pelvic tilt	30 minutes for every patient	lateral pelvic radiographic xray will be taken for each woman in order to objectify the individual pelvic tilt

Secondary Outcome Measures

Name	Time	Method
ankle range of motion	10 minutes for every patient	goniometer will be used to measure the range of motion for ankle joint
BMI	10 minutes for every patient	weight height scale will be used to measure weight and height of each woman before starting this study