Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems

Agustin Sampietro217 enrolled

Overview

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). In such sense, objective and subjective parameters will be retrospectively tested to demonstrate the safety and effectiveness of this products. Safety will be assessed by register of complications and effectiveness will be evaluated by pelvic floor reconstruction and quality of life improvements.

Study Type

OBSERVATIONAL

Enrollment

217

Conditions

Pelvic Organ Prolapse

Interventions

Calistar A mesh to treat anterior and apical POPDEVICE

Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses

Calistar S mesh to treat anterior and apical POPDEVICE

Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Británico

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Percentage of Cured Participants According to Barber Criteria

According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.

Time frame: Post-operative at 6 months

Secondary Outcomes

Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)

Assessment of POP with POP-Q quantification. Number of participants cured according to POP-Q quantification. Success criteria: POP-Q stage equal 0 or 1.

Time frame: Pre-operative and post-operative at 6 months

Quality of Life Status: Patient Global Impression Questionnaire

Patient satisfaction with the experience and the result of procedure will be evaluated with the "Patient Global Impression" questionnaire. This is a visual analogue scale range 1 (very much worse) - 5 (very much improved). A higher score a better outcome.

Time frame: Post-operative at 6 months

Adverse Events

Time frame: Intra-operative and post-operative at 6 months

Data from ClinicalTrials.gov

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