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

NCT ID: NCT01518296

Last Updated: 2013-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

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.

Conditions

Patients With Pelvic Organs Prolapse

Keywords

Pelvic Organ Prolapse Quantification (POPQ); POPQ; Urodynamic test

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Medtronic-Dantec Urodynamic System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eran Segev

Resident in Ob/Gyn department, Camel Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eran Segev, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Eran Segev, MD

Role: CONTACT

Phone: 97248250637

Email: eranse2@clalit.org.il

Facility Contacts

Eran Segev, MD

Role: primary

Other Identifiers

CMC-11-0071-CTIL

Identifier Type: -

Identifier Source: org_study_id