Calistar A vs. Calistar S - Cohort Retrospective Analysis
Conditions: Pelvic Organ Prolapse
Sponsor: Agustin Sampietro

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Calistar A vs. Calistar S - Comparative Cohort Retrospective 
Analysis of Single Incision POP Systems 
ID: CaSCaA 
Version number: Ver_03 
Date: 28/05/2018 
 
NCT03715803 
 
 
Study Protocol 
 
 

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CALISTAR A VS CALISTAR S – COHORT RETROSPECTIVE ANALYSIS 
(Ver_03 – 28/05/2018) 
 
 
 
PROTOCOL APPROVAL 
 
 
_________________________________________ 
__________________________ 
Responsible/Protocol Author/PI 
(dd/mm/yyyy) 
 
 
This protocol has been designed in accordance with the principles of Good Clinical Practices, EN-
ISO 14155, Declaration of Helsinki and other applicable regulatory requirements. 
 
 
 
 
 

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SIGNATURE PAGE 
 
CALISTAR A VS CALISTAR S – COHORT RETROSPECTIVE ANALYSIS 
(Ver_03 – 28/05/2018) 
 
I have read this protocol and agree to adhere to the requirements. I will provide copies of this protocol and all pertinent 
information to the study personnel under my supervision and my hospital ethics committee / institutional review board 
(EC/ORB). I will discuss this material with them and ensure they are fully informed regarding the device and the conduct 
of the study according to this protocol, applicable laws, and applicable regulatory requirements including Good Clinical 
Practices. 
__________________________________________ 
Clinical Site Name 
__________________________________________ 
____________________ 
Site Principal Investigator Signature 
Date 
     __________________________________________ 
               Site Principal Investigator Printed Name 
 
 
 

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TABLE OF CONTENTS 
 
SIGNATURE PAGE ................................................................................................................................................................ 3 
Table of contents ................................................................................................................................................................ 4 
GENERAL INFORMATION .................................................................................................................................................... 5 
BIBLIOGRAPHY .................................................................................................................................................................... 7 
 
 
 

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GENERAL INFORMATION 
 
Protocol ID 
 
Short title 
CALISTAR A VS CALISTAR S – Cohort retrospective analysis 
EudraCT number  
N/a 
Version 
3.0 
Date 
28/05/2018 
Coordinating investigator/project leader 
 
Dr. A. Sampietro, Gynecologist 
Hospital Universitario Austral, Department of gynaecology 
Av. Juan Domingo Perón 1500, Pilar Centro, Buenos Aires, 
Argentina 
+ 54-230-448-2163 
asampietro@live.com.ar   
Principal investigators  
See Annex 1 
Sponsor 
N/a 
Product 
Calistar A and Calistar S Single Incision POP System from 
Promedon. The products which are the object of this study have 
the approval according the CE-Guideline 93/42/EWG. 
Objective 
To compare the initial outcomes and complication of a high 
weight and a low weight meshes, Calistar A and Calistar S, 
respectively, implanted through a single incision to treat anterior 
and apical prolapses. 
Study design 
Multicentre, post-market, retrospective, two arms, non-
randomized comparative study. 
Study population 
Adult female 
Main study parameters/ primary 
endpoints 
Effectiveness of Calistar S and Calistar A will be assessed by cure 
criteria of Barber, that is: 
- Lowest point of POP-Q < 0 (no points beyond the hymen) 
- No subjective bothersome symptoms (absence of vaginal bulge 
symptoms) 
- No re-treatment/interventions on year post procedure. 

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Secondary endpoints 
The secondary endpoint is defined as the objective assessment of 
POP by POP-Q. POP-Q staging will be compared pre- and post-
operative. 
The subjective outcome is defined as the assessment of 
subjective symptoms resulting from POP by validated quality of 
life (QoL) questionnaires (improvement of the QoL of the subjects 
compared to the baseline values): 
- Pelvic Floor Distress Inventory (PFDI 20) to assess the impact of 
urinary, prolapse and colorectal distress post-operative.  
- Pelvic Organ Prolapse/ Urinary Incontinence Sexual 
Questionnaire (PISQ-12) to evaluate sexual function in women 
with pelvic organ prolapse and/or urinary incontinence post-
operative.  
- Patient Global Impression to evaluate patient satisfaction with 
the experience and the result of procedure. 
Type of surgery and operative time will be compared for both 
pelvic floor systems repair. 
Safety endpoints 
Operative complications such as bladder injury and blood loss will 
be evaluated. Complications related to the use of meshes such as 
vaginal pain, infection and mesh erosion will be assessed. 
Inclusion criteria 
Female; 
Anterior and apical prolapse Stage 3 (according to POP-Q) or 
more with or without 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 
 
 
 

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BIBLIOGRAPHY 
1.  
SCENIHR. Opinion on The safety of surgical meshes used in urogynecological surgery. 2015. 105 p.  
2.  
Amid PK. Classification of biomaterials and their related complications in abdominal wall hernia 
surgery. Hernia [Internet]. 1997;1(1):15–21. Available from: 
http://link.springer.com/10.1007/BF02426382 
3.  
De Tayrac R, Madelenat P. Évolution Des Diff́Rentes Voies D’Abord Chirurgicales Dans L’Incontinence 
Urinaire D’Effort F́Minine. Gynecol Obstet Fertil. 2004;32(12):1031–8.  
4.  
PALMA P, RICCETTO C, ALTUNA S, BARREIRO TM, SARDI J, LEDESMA M, et al. Simultaneous single 
incision transvaginal mesh to treat anterior and apical prolapses - A midterm results. IUGA 38th 
Annu Meet. 2013;Poster 470.  
5.  
Bigozzi MA, Provenzano S, Maeda F, Palma PCR, Riccetto CZ. In Vivo Biomechanical Properties of 
Heavy Versus Light Weight Monofilament Polypropylene Meshes. Does the Knitting Pattern Matter? 
Neurourol Urodyn. 2015;  
6.  
Barber MD, Brubaker L, Nygaard I, Wheeler TL, Schaffer J, Chen Z, et al. Defining success after 
surgery for pelvic organ prolapse. Obstet Gynecol. 2009;114(3):600–9.  
7.  
Haylen BT, Maher CF, Barber MD, Camargo S, Dandolu V, Digesu A, et al. an International 
Urogynecological Association (Iuga) / International Continence Society (Ics) Joint Report on the 
Terminology for Female Pelvic Organ Prolapse (Pop) . 2015;655–84.  
8.  
Toozs-Hobson P, Freeman RM, Barber M, Maher C, Haylen B, Athanasiou S, et al. An International 
Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the 
terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Int Urogynecol 
J. 2012;23(5):527–35.  
9.  
Clavien P a, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien-Dindo 
classification of surgical complications: five-year experience. Ann Surg. 2009;250(2):187–96.