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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03825653
• Other study ID #: P.T.REC/012/001885
• Status: Not yet recruiting
• Start date: January 29, 2019
• Est. completion date: February 2020

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: yara n zaki, M sc.
• Phone: 01010446044
• Email: ynz.yara[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Their BMI is not exceeding 30 kg/m2.

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.)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 70 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 minutes for every patient
Primary	posterior urethrovesical angle	perineal ultrasound will be used to assesse the posterior urethrovesical angle for each woman	30 minutes for every patient
Primary	pelvic tilt	lateral pelvic radiographic xray will be taken for each woman in order to objectify the individual pelvic tilt	30 minutes for every patient
Secondary	ankle range of motion	goniometer will be used to measure the range of motion for ankle joint	10 minutes for every patient
Secondary	BMI	weight height scale will be used to measure weight and height of each woman before starting this study	10 minutes for every patient