A New POP (Pelvic Organ Prolapse) Scoring System: Validity and Reliability

November 20, 2024 updated by: Ahmed ElHarty, Cairo University

A New POP(Pelvic Organ Prolapse) Scoring System: Validity and Reliability

There is a strong need for a better, simplified and informative applicable classification system that should be used to speak a common descriptive language among health care providers that treat POP.

The aim of our study is to test our proposed system, assess its validity and value in comparison to the widely used current system (POP-Q).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients presented with organ prolapse in the outpatient clinic will be reviewed. Patients are eligible for enrollment in the study when they are complied with all general inclusion criteria, and when none of the exclusion criteria are met after getting written consent from the patients. Study location: (Please provide where the study will be conducted and from where study participants will be recruited) Obstetrics and Gynecology Department, Cairo University Hospital ( Kasr Al Aini), Faculty of Medicine, Cairo University.

All eligible patients will undergo a baseline clinical examination to collect clinical data. This consisted of detailed medical history (including age, parity, detailed obstetric history in the mode of delivery and circumstances associated with each delivery), symptoms, exacerbating and relieving factors, associated symptoms, medication record, history of any previous treatment as pelvic floor muscle training or surgeries, physical examination including weight & height, abdominal and pelvic examination , and clinical category of prolapse according to the POP Q classification system.

Interventions details:

A FIXED APCD classification system will be used to grade the patient symptoms as follows:

A: Associated symptoms:

Incontinence Urgency Constipation Vaginal keratosis/ ulceration

FIXED: the following symptoms will be noted down and graded from 0-10 according to severity:

F: frequency I: infection X: sex problems E: everted mass(external protrusion of mass from the valva as PV lump sensation ,heaviness,itching and ulceration) D: digitation(patient need to digitate to complete the act of micturation or defecation)

APCD: The recruited subject will be examined in lithotomy position. Inspection of the perineum and introitus to look for any vaginal keratosis and measure the introitus length. Examination will be done using sims speculum while the patient is in sims position. The following points will be assessed and noted down as follows:

A: Dependent point on anterior wall. P: Dependent point on posterior wall. C: Cuff point either cervix or vault. Distance to hymen in centimeters (minus above or plus below) after pushing the opposite wall during maximal straining D: Dimensions; base diameter of vestibule/ perineal length.

The staging system will be interpreted as follows:

Normal:

A-3 P-3 C-8 D 2/2

Stages:

0: No prolapse.

  1. A/P-2 OR C-7 to C-2
  2. A,P or C-1 to +1
  3. A,P or C ˃ +1

X component: (alone or with any stage):

Dimension disruption: ˃2 or <2

In order to test the interobserver reliability of the classification system, both history taking and examination will be done by trainee and specialist. The intraobserver reliability will be assessed by repeating the examination by the same examiner two weeks later.

The reliability of the scoring system will be assessed by comparing it to the POP Q classification system, results obtained for each patient at recruitment regarding accuracy and time consumed in the assessed scoring system (using a stopwatch to calculate the time needed for each system applied).

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Doaa Adel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients presented with organ prolapse in the outpatient clinic will be reviewed. Patients were eligible for enrollment in the study when they complied with all general inclusion criteria, and when none of the exclusion criteria were met. After verification of the inclusion and exclusion criteria, written informed consent for the collection of personal medical data was obtained for each patient before enrollment in the study The location of the study will be at theObstetrics and Gynecology Department, Cairo University Hospital ( Kasr Al Aini), Faculty of Medicine, Cairo University.

Description

Inclusion Criteria:

Age : 18 years and more Symptoms : Pelvic heaviness, urinary symptoms as: stress urinary incontinence, voiding difficulties, dysuria frequency, bowel symptoms as difficulty in defecation sexual symptoms Informed consent

Exclusion Criteria:

Refusal intolerance to the physical examination

  • presence of pelvic floor disorders secondary to neurological disease malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-observer reliability and validity of the new POP scoring system
Time Frame: one year

The staging system will be interpreted as follows:

Normal:

A-3 P-3 C-8 D 2/2

Stages:

0: No prolapse.

  1. A/P-2 OR C-7 to C-2
  2. A,P or C-1 to +1
  3. A,P or C ˃ +1

X component: (alone or with any stage):

Dimension disruption: ˃2 or <2
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to complete the new classification system
Time Frame: one year
Time required to complete the new classification system
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Ashraf El-Daly, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

November 5, 2024

Study Registration Dates

First Submitted

July 20, 2024

First Submitted That Met QC Criteria

July 20, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-16_2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pelvic Organ Prolapse

Clinical Trials on Prolapse scoring system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe