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

Pelvic Organ Prolapse Clinical Trial

Official title:

Calistar A vs. Calistar S - Cohort Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715803
• Other study ID #: CaSCaA
• Status: Completed
• Start date: October 25, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2020
• Source: University of Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: December 30, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Calistar A mesh to treat anterior and apical POP
Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses
• Calistar S mesh to treat anterior and apical POP
Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses

Locations

Country	Name	City	State
Argentina	Hospital Británico	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Agustin Sampietro

Country where clinical trial is conducted

Argentina, 

References & Publications (5)

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):600-9. doi: 10.1097/AOG.0b013e3181b2b1ae. — View 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. — View Citation

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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. — View Citation

de Tayrac R, Madelenat P. [Evolution of surgical routes in female stress urinary incontinence]. Gynecol Obstet Fertil. 2004 Dec;32(12):1031-8. Review. French. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life: PFDI 20	Quality of life assessed with "Pelvic Floor Distress Inventory (PFDI 20)" questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress).	Post-operative at 6 months
Other	Quality of Life: PISQ-12	Quality of life assessed with "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. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48.	Post-operative at 6 months
Primary	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.	Post-operative at 6 months
Secondary	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.	Pre-operative and post-operative at 6 months
Secondary	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.	Post-operative at 6 months
Secondary	Adverse Events	Register of adverse events. Clavien-Dindo classification	Intra-operative and post-operative at 6 months