N/A
Completed N=217
Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems
Source: ClinicalTrials.gov NCT03715803 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Cured Participants According to Barber Criteria — 82.42; 90.48 percentage of cured patients
Summary
The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Cured Participants According to Barber Criteria |
82.42; 90.48 | — |
| SECONDARY Percentage of Participants Cured According to Objective Measure (POP-Q Quantification) |
82.42; 88.88 | — |
| SECONDARY Quality of Life Status: Patient Global Impression Questionnaire |
5; 5 | — |
| SECONDARY Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Female
- Anterior and apical prolapse Stage 3 (according to POP-Q) or more with or without stress urinary incontinence (SUI)
- Primary or recurrent treatment with Calistar S or Calistar A
- At least 6 months follow-up
Exclusion Criteria
- Recurrent vaginal infections,
- Chronic colorectal diseases (chronic nonspecific ulcerative colitis, diverticulitis, diverticulosis, Chron's disease, irritable bowel syndrome, familial polyposis).
- Presence of any coagulopathies,
- Impairment of the immune system or any condition that compromises recovery,
- Prior irradiation
- Chronic pelvic pain
Data sourced from ClinicalTrials.gov (NCT03715803). 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. Informational only — not medical advice.