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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Eran Segev, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01518296
First received: January 22, 2012
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Patients With Pelvic Organs Prolapse
Device: Medtronic-Dantec Urodynamic System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Rating the Degree of Pelvic Organs Prolapse in Women According to the POPQ Method Before and After Emptying the Urinary Bladder

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Evaluating the degree of pelvic organs prolapse according to POPQ method, with filled and empty urinary bladder, during urodynamic test [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients referred to urodynamic test
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.
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518296

Contacts
Contact: Eran Segev, MD 97248250637 eranse2@clalit.org.il

Locations
Israel
Carmel Medical Center Recruiting
Haifa, Israel
Contact: Eran Segev, MD    97248250637    eranse2@clalit.org.il   
Principal Investigator: Eran Segev, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Eran Segev, MD Carmel Medical Center
  More Information

No publications provided

Responsible Party: Eran Segev, Resident in Ob/Gyn department, Camel Medical Center, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01518296     History of Changes
Other Study ID Numbers: CMC-11-0071-CTIL
Study First Received: January 22, 2012
Last Updated: March 28, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
Pelvic Organ Prolapse Quantification (POPQ)
POPQ
Urodynamic test

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014