Clinical trial NCT03715803: Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems
Official title: Calistar A vs. Calistar S - Cohort Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: University of Buenos Aires
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults female

Brief 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).

Detailed 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.

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

Primary outcomes:
measure: Percentage of Cured Participants According to Barber Criteria
timeFrame: Post-operative at 6 months
Secondary outcomes:
measure: Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)
timeFrame: Pre-operative and post-operative at 6 months
measure: Quality of Life Status: Patient Global Impression Questionnaire
timeFrame: Post-operative at 6 months
measure: Adverse Events
timeFrame: Intra-operative and post-operative at 6 months
Other outcomes:
measure: Quality of Life: PFDI 20
timeFrame: Post-operative at 6 months
measure: Quality of Life: PISQ-12
timeFrame: Post-operative at 6 months
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Británico
Study officials:
affiliation: Faculty of Medicine, University of Buenos Aires
name: Agustín Sampietro, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Tayrac R, Madelenat P. [Evolution of surgical routes in female stress urinary incontinence]. Gynecol Obstet Fertil. 2004 Dec;32(12):1031-8. doi: 10.1016/j.gyobfe.2004.10.019. French.
citation: Bigozzi MA, Provenzano S, Maeda F, Palma P, Riccetto C. In vivo biomechanical properties of heavy versus light weight monofilament polypropylene meshes. Does the knitting pattern matter? Neurourol Urodyn. 2017 Jan;36(1):73-79. doi: 10.1002/nau.22890. Epub 2015 Oct 5.
citation: Barber MD, Brubaker L, Nygaard I, Wheeler TL 2nd, Schaffer J, Chen Z, Spino C; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009 Sep;114(3):600-609. doi: 10.1097/AOG.0b013e3181b2b1ae.
citation: Toozs-Hobson P, Freeman R, Barber M, Maher C, Haylen B, Athanasiou S, Swift S, Whitmore K, Ghoniem G, de Ridder D; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Neurourol Urodyn. 2012 Apr;31(4):415-21. doi: 10.1002/nau.22238.
citation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.