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Completed

NCT Number: NCT03715803

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

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).

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Británico

Buenos Aires, C1280AEB, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calistar A mesh to treat anterior and apical POP

Device

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

Calistar S mesh to treat anterior and apical POP

Device

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

Primary outcomes

  1. Percentage of Cured Participants According to Barber Criteria

    Time frame: Post-operative at 6 months

    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.

Secondary outcomes

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

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

    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.

  2. Quality of Life Status: Patient Global Impression Questionnaire

    Time frame: Post-operative at 6 months

    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.

  3. Adverse Events

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

    Register of adverse events. Clavien-Dindo classification

Other outcomes

  1. Quality of Life: PFDI 20

    Time frame: Post-operative at 6 months

    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).

  2. Quality of Life: PISQ-12

    Time frame: Post-operative at 6 months

    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.

Sponsors and collaborators

Lead sponsor

Agustin Sampietro

Other

Registry information

Official study title

Calistar A vs. Calistar S - Cohort Retrospective Analysis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2018
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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