Rating Pelvic Organs Prolapse in Women According to the POPQ Method Before and After Emptying the Urinary Bladder
Primary Purpose
Patients With Pelvic Organs Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Medtronic-Dantec Urodynamic System
Sponsored by
About this trial
This is an interventional diagnostic trial for Patients With Pelvic Organs Prolapse focused on measuring Pelvic Organ Prolapse Quantification (POPQ), POPQ, Urodynamic test
Eligibility Criteria
Inclusion Criteria:
- Women with pelvic organs prolapse
- Women who can read and understand and sign consent form
- Women between 20 and 90 years of age.
Exclusion Criteria:
- Women who underwent vaginal gynecologic surgery in the past
- women that underwent hysterectomy
Sites / Locations
- Carmel Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients referred to urodynamic test
Arm Description
Patients that are referred to urogynecology and the pelvic reconstruction unit undergoes a physical gynecological examination and a urodynamic test, During which the degree of pelvic organs prolapse is evaluated with full and empty bladder.
Outcomes
Primary Outcome Measures
Evaluating the degree of pelvic organs prolapse according to POPQ method, with filled and empty urinary bladder, during urodynamic test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01518296
Brief Title
Rating Pelvic Organs Prolapse in Women According to the POPQ Method Before and After Emptying the Urinary Bladder
Official Title
Rating the Degree of Pelvic Organs Prolapse in Women According to the POPQ Method Before and After Emptying the Urinary Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pelvic organ prolapse is a common disorder that affects 3-9% of adult women. Treatment of this disorder varies and includes conservative and interventional treatment.
Pelvic organs prolapse grading has an important roll in determining the appropriate treatment. Developments in this field has led to the development of an agreed method to rate the degree of pelvic organs prolapse (POPQ).
The roll of Urodynamic test is to assess whether there is urinary incontinence and underlying cause.
In Richard C. et al publication, that presented the Pelvic Organ Prolapse Quantification (POPQ) method for the first time, there was no reference to the urinary bladder state (full or empty) during the examination, hence the investigators are asking to conduct a prospective study in order to evaluate the degree of pelvic organs prolapse according to POPQ method during urodynamic examination, with a full and empty urinary bladder.
Detailed Description
Pelvic organ prolapse is a common disorder that affects 3-9% of adult women. Treatment of this disorder varies and includes behavioral therapy, pelvic floor muscles rehabilitation exercises, medication therapy, devices that are tailored to the patient in order to improve pelvic organ support and various surgical procedures. Developments in this field and the need to tailor the appropriate treatment to the type and degree of pelvic organ prolapse resulted in the development of an agreed method to rate the degree of pelvic organs prolapse.
Pelvic organs prolapse grading has an important roll in determining the appropriate treatment. A big proportion of women who suffer from pelvic organ prolapse suffer from urinary system disorders as well, such as difficulty in urinating, urinary incontinence, and urgency and frequency.
At the pelvic floor reconstruction clinic, women who suffer from pelvic organs prolapse, undergo a preliminary workup that includes a medical questionnaire, physical examination to evaluate the degree of pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification method (POPQ), and a urodynamic test.
The impression of differences in the degree of prolapse according to POPQ method, before and after urination, has led to the hypothesis that the degree of pelvic organs prolapse varies according to the degree of fullness of the bladder
Urodynamic test is a test performed during patient evaluation at the pelvic floor reconstruction clinic. During this test the woman is asked to empty her bladder and then two transducers are inserted, one into the bladder and the other into the rectum. During the test the bladder is filled with physiological solution and then the patient is asked to urinate. During bladder emptying urinary flow velocity is measured and the pressure in the abdomen and bladder recorded for later evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Pelvic Organs Prolapse
Keywords
Pelvic Organ Prolapse Quantification (POPQ), POPQ, Urodynamic test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients referred to urodynamic test
Arm Type
Experimental
Arm Description
Patients that are referred to urogynecology and the pelvic reconstruction unit undergoes a physical gynecological examination and a urodynamic test, During which the degree of pelvic organs prolapse is evaluated with full and empty bladder.
Intervention Type
Device
Intervention Name(s)
Medtronic-Dantec Urodynamic System
Intervention Description
Urodynamic test is test performed in order to assess whether there is a urinary incontinence and underlying cause. During this test the woman is asked to empty her bladder and then two transducers are inserted, one into the bladder and the other into the rectum, then the bladder is filled with physiological solution and the patient is asked to urinate. During bladder emptying urinary flow velocity is measured and the pressures in the abdomen and bladder are recorded for later evaluation
Primary Outcome Measure Information:
Title
Evaluating the degree of pelvic organs prolapse according to POPQ method, with filled and empty urinary bladder, during urodynamic test
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with pelvic organs prolapse
Women who can read and understand and sign consent form
Women between 20 and 90 years of age.
Exclusion Criteria:
Women who underwent vaginal gynecologic surgery in the past
women that underwent hysterectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Segev, MD
Phone
97248250637
Email
eranse2@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eran Segev, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Segev, MD
Phone
97248250637
Email
eranse2@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Eran Segev, MD
12. IPD Sharing Statement
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Rating Pelvic Organs Prolapse in Women According to the POPQ Method Before and After Emptying the Urinary Bladder
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