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

Agustin Sampietro

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: Calistar A mesh to treat anterior and apical POP; Device: Calistar S mesh to treat anterior and apical POP

Study type: Observational

Funder types: Other

Identifiers

NCT03715803

CaSCaA

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 217 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

217 participants in 2 patient groups

Calistar A

Description:

Calistar A mesh to treat anterior and apical POP

Treatment:

Device: Calistar A mesh to treat anterior and apical POP

Calistar S

Description:

Calistar S mesh to treat anterior and apical POP

Treatment:

Device: Calistar S mesh to treat anterior and apical POP