Skip to main content
OpenTrials
Completed

NCT Number: NCT06520722

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).

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

  • A/P-2 OR C-7 to C-2
  • A,P or C-1 to +1
  • 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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prolapse scoring system

Diagnostic Test

A FIXED APCD classification system :

A: Associated symptoms:

FIXED:

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:

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.

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

X component: (alone or with any stage):

Dimension disruption: ˃2 or <2

Primary outcomes

  1. 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.

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

    X component: (alone or with any stage):

    Dimension disruption: ˃2 or <2

Secondary outcomes

  1. Time required to complete the new classification system

    Time frame: one year

    Time required to complete the new classification system

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.