Three-dimensional Ultrasound Assessment in Cases of Prolapse Surgeries
Clinical and Three-dimensional Ultrasound Assessment of Cases With Apical Prolapse Surgeries. A Prospective Cohort Study
1 other identifier
interventional
1
1 country
1
Brief Summary
The levator ani muscle seems to play a key role in pelvic floor dysfunction. This muscle has two major components, the pubovisceral (including the pubococcygeus and puborectalis muscles) and the iliococcygeal muscles.Major levator ani defects are associated with pelvic organ prolapse (POP) and POP recurrence
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedMarch 5, 2019
March 1, 2019
2 years
February 26, 2019
March 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
2 years
Study Arms (1)
prolapse surgery
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- I. Arabic female that is able to understand the instructions and the questionnaires that will be given II. Apical prolapse Stage 2-4 (according to POP-Q)(30,33) III. Sexually active (at least 3 times every month)
You may not qualify if:
- Pregnancy
- Postpartum women during the 1st 6 months postpartum
- Human papillomavirus vulvar disease (condyloma acuminata)
- Patient unfit for surgery
- Previous pelvic reconstruction surgery.
- Factors affecting healing process as uncontrolled diabetes, steroid therapy, on chemotherapy,….. etc
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women Health Hospital
Asyut, Egypt
Related Publications (2)
Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse? Eur J Obstet Gynecol Reprod Biol. 1999 May;84(1):23-5. doi: 10.1016/s0301-2115(99)00002-0.
PMID: 10413222RESULTLin KL, Juan YS, Chou SH, Long CY. Ultrasonographic Assessment with Three-Dimensional Mode of the Urethral Compression Effect following Sling Surgery with and without Mesh Surgery. Biomed Res Int. 2019 Jan 6;2019:8285351. doi: 10.1155/2019/8285351. eCollection 2019.
PMID: 30723744RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 28, 2019
Study Start
July 1, 2019
Primary Completion
July 1, 2021
Study Completion
September 1, 2021
Last Updated
March 5, 2019
Record last verified: 2019-03