Clinical trial NCT06520722: A New POP (Pelvic Organ Prolapse) Scoring System: Validity and Reliability
Official title: A New POP(Pelvic Organ Prolapse) Scoring System: Validity and Reliability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Prolapse
Prolapse, Vaginal
Prolapse Uterus
Prolapse; Cervix
Keywords: Prolapse
Pelvic organ prolapse
POP-Q
Procidentia
Uterine prolapse
Vaginal prolapse
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Inter-observer reliability and validity of the new POP scoring system
timeFrame: one year
Secondary outcomes:
measure: Time required to complete the new classification system
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaa Adel
Study officials:
affiliation: Cairo University
name: Ashraf El-Daly, MD
role: STUDY_DIRECTOR
References:
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