A New POP (Pelvic Organ Prolapse) Scoring System: Validity and Reliability
NCT ID: NCT06520722
Last Updated: 2024-11-22
Study Results
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Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2023-09-01
2024-11-05
Brief Summary
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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).
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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Prolapse scoring system
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* presence of pelvic floor disorders secondary to neurological disease malignancy.
18 Years
70 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed ElHarty
Lecturer
Principal Investigators
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Ashraf El-Daly, MD
Role: STUDY_DIRECTOR
Cairo University
Locations
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Doaa Adel
Cairo, , Egypt
Countries
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References
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Vergeldt TF, Weemhoff M, IntHout J, Kluivers KB. Risk factors for pelvic organ prolapse and its recurrence: a systematic review. Int Urogynecol J. 2015 Nov;26(11):1559-73. doi: 10.1007/s00192-015-2695-8. Epub 2015 May 13.
Macmillan AK, Merrie AE, Marshall RJ, Parry BR. The prevalence of fecal incontinence in community-dwelling adults: a systematic review of the literature. Dis Colon Rectum. 2004 Aug;47(8):1341-9. doi: 10.1007/s10350-004-0593-0.
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
Kepenekci I, Keskinkilic B, Akinsu F, Cakir P, Elhan AH, Erkek AB, Kuzu MA. Prevalence of pelvic floor disorders in the female population and the impact of age, mode of delivery, and parity. Dis Colon Rectum. 2011 Jan;54(1):85-94. doi: 10.1007/DCR.0b013e3181fd2356.
Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
Swift S, Morris S, McKinnie V, Freeman R, Petri E, Scotti RJ, Dwyer P. Validation of a simplified technique for using the POPQ pelvic organ prolapse classification system. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Nov;17(6):615-20. doi: 10.1007/s00192-006-0076-z. Epub 2006 Apr 6.
Lemos N, Korte JE, Iskander M, Freeman R, Arunkalaivanan A, Rizk D, Halaska M, Medina C, Conceicao JC, Parekh M, Martan A, Sorinola O, Wlazlak E, Ghoniem G, Swift S. Center-by-center results of a multicenter prospective trial to determine the inter-observer correlation of the simplified POP-Q in describing pelvic organ prolapse. Int Urogynecol J. 2012 May;23(5):579-84. doi: 10.1007/s00192-011-1593-y. Epub 2011 Nov 15.
Weber AM, Abrams P, Brubaker L, Cundiff G, Davis G, Dmochowski RR, Fischer J, Hull T, Nygaard I, Weidner AC. The standardization of terminology for researchers in female pelvic floor disorders. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(3):178-86. doi: 10.1007/pl00004033.
Slieker-ten Hove MC, Pool-Goudzwaard AL, Eijkemans MJ, Steegers-Theunissen RP, Burger CW, Vierhout ME. Symptomatic pelvic organ prolapse and possible risk factors in a general population. Am J Obstet Gynecol. 2009 Feb;200(2):184.e1-7. doi: 10.1016/j.ajog.2008.08.070. Epub 2008 Dec 25.
Related Links
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Related Info
Related Info
Other Identifiers
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MD-16_2023
Identifier Type: -
Identifier Source: org_study_id
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