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Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair (CASPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821142
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Promedon

Brief Summary:
This is a prospective, long-term, single-arm, multicenter cohort study to evaluate the efficacy and safety of the Calistar S pelvic Floor repair system in women undergoing transvaginal POP repair.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Device: Transvaginal mesh for treatment pelvic organ prolapse Not Applicable

Detailed Description:

Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is a treatment kit for the surgical repair of anterior or combined anterior and apical prolapses in women. Calistar S is a transvaginal mesh for implantation between the anterior vaginal wall and the bladder wall to support the vesico-vaginal fascia. The treatment kit consists of the lightweight mesh, two single-use introducers and 3 tissue anchoring system (TAS) anchors for fixation to the sacrospinous ligament. The product is approved in accordance with the CE Directive 93/42/EEC.

The utilization of synthetic implants in POP repair became increasingly popular in the last decade. The cumulative success rate of synthetic implants in anterior compartment repair is as high as up to 93%.However, meshes have been recently scrutinized due to high adverse event reporting after unreflected utilization of meshes which raised concerns of patients safety; furthermore taking into account the complexity of adverse event mesh management. This led to a vanishing of various meshes in transvaginal POP repair. Nevertheless, the further development of light weight meshes, the experience of the surgeon and the assessment and patients selection are well known factors reducing the rate of adverse events significantly.

Therefore, in the current trial the efficacy and safety of calistar S in a highly selected patient population will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Calistar S Single Incision POP System
Masking: None (Open Label)
Masking Description: Blinded POP-Q Examination: The POP-Q examination will be performed by a physician different to the corresponding surgeon
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, 60 Months, Single Arm Cohort Study to Evaluate the Efficacy and Safety of the Ultra-Light-Weight Mesh CAlistar S in Transvaginal Pelvic Organ Prolapse Repair
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Calistar S for transvaginal pelvic organ prolapse repair
Single arm, prospective cohort trial evaluating Calistar S for transvaginal mesh repair for pelvic organ prolapse
Device: Transvaginal mesh for treatment pelvic organ prolapse
transvaginal mesh for both anterior and combined anterior and apical pelvic organ prolapse




Primary Outcome Measures :
  1. Cure of pelvic organ prolapse [ Time Frame: 24 months ]
    Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components


Secondary Outcome Measures :
  1. Prolaps Quality of Life Questionnaire [ Time Frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months ]
    Differences between Baseline and Follow-Up result of the questionnaire of each patient regarding Quality of life and the correlating domains will be evaluated. P-QoL, Score: 0-100, the higher the score, the higher the impact of prolapse symptoms and the lower quality of life.

  2. Pelvic Organ Prolapse/Incontinence Sexual Questionnaire [ Time Frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months ]
    Differences between Baseline and Follow-Up result of each patient regarding Sexual life and the correlating domains will be evaluated. PISQ-IR, Score: 0-100, the higher the score, the higher the impact of prolapse symptoms and the higher the impact on sexual life.

  3. Visual Analog Scale of Pain [ Time Frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months ]
    Differences of pain-evaluation between Baseline and Follow-Up of each patient will be evaluated. Wong Baker Pain Scale, Score: 0 - 10, The higher the score, the higher the pain.

  4. Patients satisfaction [ Time Frame: 6 weeks and 6, 12, 24, 36, 48, 60 months ]
    Evaluation of the improvement of POP after the operation assed by the Patient Global Impression of Improvement of each patient. PGI-I, Score: 7 Likert scale from: very much better to very much worse.

  5. Patient Global Impression of Severity [ Time Frame: Baseline ]
    Evaluation of severity categorization by assing the Patient Global Impression of Severity of each patient at Baseline. Score. 4 Likert scale, from no impact to very much impact.

  6. EQ-5L-5D [ Time Frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months ]
    Evaluation of Quality of life assessed by the EQ-5L-5D and evaluation of differences between Baseline and Follow-Up of each patient regarding health related Quality of life. Two scores: a) 5 Likert scale from no problems to extreme problems. b) self administered quality of life in scale 0 - 100, the higher the score the better the quality of life.

  7. Specific Anatomic success 1 [ Time Frame: 12, 24, 36 ]
    In mid-term (after ≥12-36 months), 85% of the patients will present with a POP-Q point Ba ≤1 or point Ba and C ≤ 1

  8. Specific Anatomic success 2 [ Time Frame: 60 months ]
    In long-term (after 5 years), 80% of the patient will present with a POP-Q point Ba ≤1 or point Ba and C ≤ 1 can be observed in

  9. Specific Anatomic success 3 [ Time Frame: 12 months ]
    The recurrence / revision rate with respect to point Ba or point Ba and C is less than 5% in the first year after treatment.

  10. Specific Anatomic success 4 [ Time Frame: 12, 24, 36 months ]
    The recurrence / revision rate with respect to point Ba or point Ba and C is below 5% in mid- term (after 12-36 months).

  11. Specific Anatomic success 5 [ Time Frame: 60 months ]
    The recurrence / revision rate with respect to point Ba or point Ba and C is less than 10% in long term (after 5 years).

  12. Specific subjective success 1 [ Time Frame: 12, 24, 36 months ]
    Quality of life (QoL) according ED-5Q-5L and P-QoL Questionnaire will be significantly better evaluated by 85% of the patients after ≥12 - 36 months in comparison to the baseline

  13. Specific subjective success 2 [ Time Frame: 60 months ]
    Quality of life (QoL) according ED-5Q-5L and P-QoL Questionnaire will be significantly better evaluated by 80% of the patients after ≥60 months in comparison to the baseline

  14. Urinary incontinence [ Time Frame: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months ]
    Number of patients with deNovo or worsening of urinary incontinence in comparison to baseline according the validated questionnaire ICIQ-UI-SF. Score 0-21, overall score with greater values indicating increased symptom severity

  15. Overactive Bladder [ Time Frame: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months ]
    Number of patients with Overactive bladder symptoms in comparison to baseline according the validated questionnaire ICIQ-OAB. 0-16 overall score with greater values indicating increased symptom severity

  16. Anatomical success [ Time Frame: 6 weeks and 6, 12, 24, 36, 48, 60 months ]
    Number of Patients with anatomical success according POP-Q Classification• POP/Incontinence Sexual Questionnaire IUGA revised (PISQ-12) (validated german version) (12) for the assessment of sexual function associated with genital prolapse at baseline, 12 and 24 months after the intervention.

  17. Cure in short-, mid-, and longterm follow-up [ Time Frame: 6 weeks and 6, 12, 36, 48, 60 months ]
    Number of patients accomplishing the composite outcome at remaining follow-up times

  18. Revision and Explantation free survival [ Time Frame: 6 weeks and 6, 12, 36, 48, 60 months ]
    The estimated revision and explantation free survival of number of patients according Kaplan Meier

  19. Further surgery of stress urinary incontinence [ Time Frame: 6 weeks and 6, 12, 36, 48, 60 months ]
    Frequency of necessity of further surgery to treat stress urinary incontinence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria:

  • Women ≥21 years old in postmenopausal status and/or post hysterectomy and/or sterilised
  • Symptomatic primary POP with high risk for recurrence or recurrent symptomatic either anterior or combined anterior and apical pelvic organ prolapse according POP-Q ≥ 2

Key exclusion criteria:

  • Prior pelvic prolapse implant (graft augmented repair)
  • Active or latent systemic infection or signs of tissue necrosis.
  • Premenopausal women, pregnant women or intention for pregnancy
  • Prior history of pelvic radiation therapy
  • Current medication which compromises immune response, such as immune modulators and antirheumatic medication
  • Sensitivity to polypropylene
  • Indication for a concomitant procedure to treat SUI
  • History of pelvic organ cancer (e.g. uterine, ovarian, bladder)
  • Chronic systemic/pelvic pain
  • Neurologic or medical condition affecting bladder function
  • Anticoagulant therapy which can not be temporarily bridged or stopped

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821142


Contacts
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Contact: Tanja Hüsch, PD Dr.habil. +498031900400 tanja.huesch@promedon.com

Locations
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Germany
Helios Hospital Erfurt, Department of gynaecology
Erfurt, Thüringen, Germany
Contact: Gert Naumann, PD Dr.habil.         
St. Hedwig Hospital
Berlin, Germany
Contact: Ralf Tunn, Prof.Dr.         
Netherlands
AMC Amsterdam
Amsterdam, Netherlands
Contact: Jan-Paul Roovers, Prof.Dr.         
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Contact: Wenche Klerkx, Dr.         
Sponsors and Collaborators
Promedon
Investigators
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Study Chair: Tanja Hüsch, PD Dr.habil. Promedon GmbH
Principal Investigator: Jan-Paul Roovers, Prof.Dr. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Gert Naumann, PD Dr.habil. Helios Hospital Erfurt
Principal Investigator: Ralf Tunn, Prof.Dr. St. Hedwig Hospital
Principal Investigator: Wenche Klerkx, Dr. St. Antonius Ziekenhuis
Publications:

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Responsible Party: Promedon
ClinicalTrials.gov Identifier: NCT03821142    
Other Study ID Numbers: CASPO_V2Amend01
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Promedon:
pelvic organ prolapse
mesh
Calistar
Transvaginal repair
Transvaginal mesh repair
anterior prolapse
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical