Rating Pelvic Organs Prolapse in Women According to the POPQ Method Before and After Emptying the Urinary Bladder

Patients With Pelvic Organs Prolapse Clinical Trial

Official title:

Rating the Degree of Pelvic Organs Prolapse in Women According to the POPQ Method Before and After Emptying the Urinary Bladder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01518296
• Other study ID #: CMC-11-0071-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2012
• Last updated: March 28, 2013
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2013
• Source: Carmel Medical Center
• Contact: Eran Segev, MD
• Phone: 97248250637
• Email: eranse2[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Women with pelvic organs prolapse

2. Women who can read and understand and sign consent form

3. Women between 20 and 90 years of age.

Exclusion Criteria:

1. Women who underwent vaginal gynecologic surgery in the past

2. women that underwent hysterectomy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Patients With Pelvic Organs Prolapse
• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Medtronic-Dantec Urodynamic System
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

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the degree of pelvic organs prolapse according to POPQ method, with filled and empty urinary bladder, during urodynamic test		1 year	No