Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520722
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
A New POP Pelvic Organ Prolapse Scoring System Validity and Reliability
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A New POPPelvic Organ Prolapse Scoring System Validity and Reliability
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 massexternal protrusion of mass from the valva as PV lump sensation heavinessitching and ulceration D digitationpatient 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 22
Stages
0 No prolapse
1 AP-2 OR C-7 to C-2
2 AP or C-1 to 1
3 AP 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
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 massexternal protrusion of mass from the valva as PV lump sensation heavinessitching and ulceration D digitationpatient 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 22
Stages
0 No prolapse
1 AP-2 OR C-7 to C-2
2 AP or C-1 to 1
3 AP 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None