Pelvic Organ Prolapse Clinical Trial
Official title:
Clinical and Three-dimensional Ultrasound Assessment of Cases With Apical Prolapse Surgeries. A Prospective Cohort Study
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
Status | Not yet recruiting |
Enrollment | 1 |
Est. completion date | September 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 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) Exclusion Criteria: 1. Pregnancy 2. Postpartum women during the 1st 6 months postpartum 3. Human papillomavirus vulvar disease (condyloma acuminata) 4. Patient unfit for surgery 5. Previous pelvic reconstruction surgery. 6. Factors affecting healing process as uncontrolled diabetes, steroid therapy, on chemotherapy,….. etc |
Country | Name | City | State |
---|---|---|---|
Egypt | Women Health Hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Lin 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. eColle — View Citation
Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse? Eur J Obstet Gynecol Reprod Biol. 1999 May;84(1):23-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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