Pelvic Organ ProlapseNCT06520722
A New POP (Pelvic Organ Prolapse) Scoring System: Validity and Reliability
An observational study of Pelvic Organ Prolapse and Prolapse, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Prolapse, Prolapse, Vaginal
- What is being tested?
- Prolapse scoring system
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 5 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Refusal intolerance to the physical examination
- presence of pelvic floor disorders secondary to neurological disease malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- 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).
- Being tested
- Prolapse scoring system
- Keywords
- Prolapse, Pelvic organ prolapse, POP-Q, Procidentia, Uterine prolapse, Vaginal prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolapse scoring systemDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
Measured: one year
Secondary outcomes (1)
Time required to complete the new classification system
Time required to complete the new classification system
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Sep 2023
- Primary completion20 Jul 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElHarty, Cairo University
- Investigators
- Ashraf El-Daly, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520722
- Sponsor's protocol ID
- MD-16_2023
- Status last verified
- Nov 2024
- First submitted
- 20 Jul 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25966804Macmillan 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.
PubMed 15484348Haylen 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.
PubMed 19937315Kepenekci 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.
PubMed 21160318Bump 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.
PubMed 8694033Swift 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.
PubMed 16598414Lemos 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.
PubMed 22083515Weber 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.
PubMed 11451006Slieker-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.
PubMed 19110218
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New POP(Pelvic Organ Prolapse) Scoring System: Validity and Reliability
- ClinicalTrials.gov ID
- NCT06520722
- Acronym / sponsor ID
- MD-16_2023
- Keywords
- Prolapse, Pelvic organ prolapse, POP-Q, Procidentia, Uterine prolapse, Vaginal prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal intolerance to the physical examination
- presence of pelvic floor disorders secondary to neurological disease malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolapse scoring systemA 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 | Diagnostic test | – |
Primary outcome
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. 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
1 secondary outcome
Time required to complete the new classification system
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 25966804Vergeldt 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.
- Background: PubMed 15484348Macmillan 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.
- Background: PubMed 19937315Haylen 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.
- Background: PubMed 21160318Kepenekci 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.
- Background: PubMed 8694033Bump 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.
- Background: PubMed 16598414Swift 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.
- Background: PubMed 22083515Lemos 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.
- Background: PubMed 11451006Weber 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.
- Background: PubMed 19110218Slieker-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 InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf El-Daly, MD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Prolapse, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-observer reliability and validity of the new POP scoring system (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06520722, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.