N/A
N=44
Sacro-Spinous Ligaments Anterior Apical Anchoring
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT01842464 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: The Change With Distance Between the Vaginal Apex and the Introitus — -4.4 centimeters
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Anterior Sacro-Spinous (Procedure)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Western Galilee Hospital-Nahariya
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change With Distance Between the Vaginal Apex and the Introitus |
-4.4 | — |
| PRIMARY Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring |
44 | — |
| PRIMARY Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure |
— | — |
Summary
Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
Eligibility Criteria
Inclusion Criteria
- Pelvic Floor Prolapse > Gr 2,
- Anterior > Posterior defect,
- Apical Supportive Defect
Exclusion Criteria
- Active Pelvic Inflammation,
- Patient Refusal
Data sourced from ClinicalTrials.gov (NCT01842464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.