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

NCT06520722 | Completed

• 1 other identifier: MD-16_2023
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Organ Prolapse; Prolapse; Prolapse, Vaginal; Prolapse Uterus; Prolapse; Cervix

Keywords

Prolapse; Pelvic organ prolapse; POP-Q; Procidentia; Uterine prolapse; Vaginal prolapse

Outcome Measures

Primary Outcomes (1)

• Inter-observer reliability and validity of the new POP scoring system

  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 Outcomes (1)

• Time required to complete the new classification system

  one year

Interventions

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal intolerance to the physical examination
• presence of pelvic floor disorders secondary to neurological disease malignancy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Doaa Adel

Cairo, Egypt

Location

Related Publications (9)

• 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.

  PMID: 25966804 BACKGROUND

• 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.

  PMID: 15484348 BACKGROUND

• 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.

  PMID: 19937315 BACKGROUND

• 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.

  PMID: 21160318 BACKGROUND

• 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.

  PMID: 8694033 BACKGROUND

• 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.

  PMID: 16598414 BACKGROUND

• 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.

  PMID: 22083515 BACKGROUND

• 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.

  PMID: 11451006 BACKGROUND

• 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.

  PMID: 19110218 BACKGROUND

Related Links

• Related Info
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MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse; Uterine Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ashraf El-Daly, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: September 1, 2023
• Primary Completion: July 20, 2024
• Study Completion: November 5, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)