Pelvic Organ ProlapseNCT03715803

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

An observational study of Pelvic Organ Prolapse, run by Agustin Sampietro at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse
What is being tested?: Calistar A mesh to treat anterior and apical POP and Calistar S mesh to treat anterior and apical POP
Type of treatment: Medical device
How many people: 217 participants
Where: 1 siteArgentina
Study dates: 25 Oct 2018to 30 Dec 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Adults female

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Argentina1 site

Hospital Británico
Buenos Aires, C1280AEB

Other trials in Argentina

About this study

Official title: Calistar A vs. Calistar S - Cohort Retrospective Analysis

Read the 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.

Conditions: Pelvic Organ Prolapse
Being tested: Calistar A mesh to treat anterior and apical POP, Calistar S mesh to treat anterior and apical POP
Medical subject headings: Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03715803
Study group	Role	What they receive
Calistar A		Calistar A mesh to treat anterior and apical POP Receives: Device: Calistar A mesh to treat anterior and apical POP
Calistar S		Calistar S mesh to treat anterior and apical POP Receives: Device: Calistar S mesh to treat anterior and apical POP

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Post-operative at 6 months

Secondary outcomes (3)

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.
Measured: Pre-operative and post-operative at 6 months
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.
Measured: Post-operative at 6 months
Adverse Events
Register of adverse events. Clavien-Dindo classification
Measured: Intra-operative and post-operative at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 201830 Dec 2019

First posted23 Oct 2018
Study start25 Oct 2018
Primary completion20 Aug 2019
Study completion30 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03715803
Sponsor's protocol ID: CaSCaA
Status last verified: Mar 2020
First submitted: 26 Sep 2018
Last updated: 20 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Only final clinical study report will be shared with the researchers participating in the study

Publications

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.
PubMed 15589779
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.
PubMed 26436858
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.
PubMed 19701041
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.
PubMed 22517068
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.
PubMed 19638912

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Calistar A vs. Calistar S - Cohort Retrospective Analysis
ClinicalTrials.gov ID: NCT03715803
Acronym / sponsor ID: CaSCaA
Conditions: Pelvic Organ Prolapse
Study type: Observational
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Agustin SampietroUniversity, hospital or other
Study start: 25 Oct 2018 (actual)
Primary completion: 20 Aug 2019 (actual)
Study completion: 30 Dec 2019 (actual)
First posted: 23 Oct 2018 (actual)
Results: Posted 20 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Calistar A	–	Device: Calistar A mesh to treat anterior and apical POPCalistar A mesh to treat anterior and apical POP
Calistar S	–	Device: Calistar S mesh to treat anterior and apical POPCalistar S mesh to treat anterior and apical POP

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults female

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calistar A mesh to treat anterior and apical POPSingle incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Device	Calistar A
Calistar S mesh to treat anterior and apical POPSingle incision surgery using Calistar S to treat anterior and apical pelvic prolapses	Device	Calistar S

Primary outcome

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.

3 secondary outcomes

Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)
Time frame: Pre-operative and post-operative at 6 months
Quality of Life Status: Patient Global Impression Questionnaire
Time frame: Post-operative at 6 months
Adverse Events
Time frame: Intra-operative and post-operative at 6 months

Results and safety

Results posted to the registry on 20 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Calistar A	91	91
Calistar S	126	126

Primary outcome: Percentage of Cured Participants According to Barber Criteria

Time frame: Post-operative at 6 months. Number. Unit: percentage of cured patients

Measure	Calistar A n = 91	Calistar S n = 126
Value	82.42	90.48

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calistar A	0 of 91 (0%)	30 of 91 (33%)	0 of 91
Calistar S	0 of 126 (0%)	14 of 126 (11.1%)	0 of 126

Limitations and caveats (from the sponsor): Retrospective study; CaA procedures started a long time before the first CaS cases (Ca S level of surgeon training more experienced). Available data only enables mid-term follow-ups of differing duration's between the two groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15589779de 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.
Background: PubMed 26436858Bigozzi 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.
Background: PubMed 19701041Barber 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.
Background: PubMed 22517068Toozs-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.
Background: PubMed 19638912Clavien 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.
Individual participant dataSharing planned: No. Only final clinical study report will be shared with the researchers participating in the study

Related trials for Pelvic Organ Prolapse

Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Agustín Sampietro, Dr principal investigator

Faculty of Medicine, University of Buenos Aires

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Organ Prolapse, run by Agustin Sampietro at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Cured Participants According to Barber Criteria (time frame: Post-operative at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03715803, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.