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

Primary Purpose

Pelvic Organ Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transvaginal mesh for anterior pelvic organ prolapse repair
Sponsored by
Promedon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring surgical mesh, surgery, Therapy, pelvic floor disorders, cystocele

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria Non-fertile women > 18 years1 2. Symtomatic anterior prolapse with or without apical vaginal wall involvement according POP-Q score ≥ 2. (Corresponding to Aa, Ba ≥ -1 and where applicable C ≥ -1/2 TVL ).

3. Subjects with recurrent prolapse or complex primary prolapse are eligible for the study.

4. Scheduled mesh-augmented anterior POP repair with Calistar S 5. Signed inform consent

Exclusion criteria

  1. Fertile women
  2. Patients with active or latent infection of the vagina, cervix or uterus
  3. Patients with previous or current vaginal, cervical or uterine cancer
  4. Previous, current or planned pelvic radiation therapy
  5. Known allergy to polypropylene

7. Subject is unable or unwilling to complete questionnaires (either self-administered, assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent

Sites / Locations

  • Helios Hospital Erfurt, Department of gynaecologyRecruiting
  • St. Hedwig HospitalRecruiting
  • Evangelic Diakonie HospitalRecruiting
  • St. Elisabeth-Hospital LeipzigRecruiting
  • Hospital TettnangRecruiting
  • University Hospital TübingenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calistar S

Arm Description

Single arm cohort trial

Outcomes

Primary Outcome Measures

Number of Patients with Cure of pelvic organ prolapse
Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components

Secondary Outcome Measures

Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up
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.
Change of sexual life according the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire in comparison between Baseline and follow-up
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.
Change of pain according Visual Analog Scale of Pain in comparison between baseline, postoperative and follow-up
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.
Patients subjective evaluation of satisfaction with surgery according the Patient Global Impression of Improvement
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,
Patient subjective evaluation of POP severity according the Global Impression of Severity
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. A
Change of quality of life according the EQ-5L-5D in comparison between baseline and follow-up
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.
Anatomical success according the number of patients with anterior vaginal wall at or above the hymen and no decent of apical vaginal wall at or greater than half of the total vanilla lengths
Anatomical success defined by the number of patients with the anterior vaginal wall at or above the hymen (Aa and Ba ≤ 0 ) and separately no decent of apical vaginal wall at or greater than half of the total vaginal lengths (C < -½ TVL).
Number of patients with necessity of repeated surgery due to recurrent anterior or apical Number of patients with Repeat surgery due to symptomatic recurrence of anterior or apical POP
Number of patients with necessity of repeated surgery due to recurrent anterior or apical POP.
Safety of Calistar S according the number of adverse events
Safety of Calistar S according the assessment of total amount of adverse events
Exposure and anatomical-failure free survival
Estimation of exposure- and anatomical-failure free survival according Kaplan meier
Number of patients with further surgery for stress urinary incontinence
To assess the number of patients with further surgery for stress urinary incontinence.
Change of urinary incontinence according the ICIQ-UI-Sf in comparison between baseline and follow-up
The international Consultation of Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) is a validated questionnaire to asses urinary incontinence. Score 0-21, overall score with greater values indicating increased symptom severity
Change of overactive bladder symptoms according the ICIQ-OAB in comparison between baseline and follow-up
The International Consultation of Incontinence Questionnaire - Overacitve bladder (ICIQ-OAB) is a validated questionnaire.. 0-16 overall score with greater values indicating increased symptom severity
Cure in short-, mid-, and longterm follow-up
Number of patients accomplishing the composite outcome at remaining follow-up times

Full Information

First Posted
January 10, 2019
Last Updated
May 4, 2022
Sponsor
Promedon
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1. Study Identification

Unique Protocol Identification Number
NCT03821142
Brief Title
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair
Acronym
CASPO
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
March 10, 2025 (Anticipated)
Study Completion Date
March 10, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promedon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement
Detailed Description
Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is intended for transvaginal reestablishment and reinforcement of the physiologic anatomy of the female pelvic floor in non-fertile women with anterior pelvic organ prolapse with or without apical vaginal wall involvement in both, recurrent pelvic organ prolapse and primary pelvic organ prolapse when other surgical procedures are expected to fail (i.e. complex primary prolapse). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
surgical mesh, surgery, Therapy, pelvic floor disorders, cystocele

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calistar S
Arm Type
Experimental
Arm Description
Single arm cohort trial
Intervention Type
Device
Intervention Name(s)
Transvaginal mesh for anterior pelvic organ prolapse repair
Intervention Description
synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population
Primary Outcome Measure Information:
Title
Number of Patients with Cure of pelvic organ prolapse
Description
Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up
Description
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.
Time Frame
Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Change of sexual life according the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire in comparison between Baseline and follow-up
Description
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.
Time Frame
Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Change of pain according Visual Analog Scale of Pain in comparison between baseline, postoperative and follow-up
Description
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.
Time Frame
Baseline, 24-48h postoperatively, 6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Patients subjective evaluation of satisfaction with surgery according the Patient Global Impression of Improvement
Description
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,
Time Frame
6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Patient subjective evaluation of POP severity according the Global Impression of Severity
Description
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. A
Time Frame
Baseline
Title
Change of quality of life according the EQ-5L-5D in comparison between baseline and follow-up
Description
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.
Time Frame
Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Anatomical success according the number of patients with anterior vaginal wall at or above the hymen and no decent of apical vaginal wall at or greater than half of the total vanilla lengths
Description
Anatomical success defined by the number of patients with the anterior vaginal wall at or above the hymen (Aa and Ba ≤ 0 ) and separately no decent of apical vaginal wall at or greater than half of the total vaginal lengths (C < -½ TVL).
Time Frame
6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Number of patients with necessity of repeated surgery due to recurrent anterior or apical Number of patients with Repeat surgery due to symptomatic recurrence of anterior or apical POP
Description
Number of patients with necessity of repeated surgery due to recurrent anterior or apical POP.
Time Frame
6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Safety of Calistar S according the number of adverse events
Description
Safety of Calistar S according the assessment of total amount of adverse events
Time Frame
intraoperative, postoperative, 6 weeks, and 6, 12, 24, 36, 48, 60 months and unscheduled visits
Title
Exposure and anatomical-failure free survival
Description
Estimation of exposure- and anatomical-failure free survival according Kaplan meier
Time Frame
12, 24, 36, 48, 60 months
Title
Number of patients with further surgery for stress urinary incontinence
Description
To assess the number of patients with further surgery for stress urinary incontinence.
Time Frame
6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Change of urinary incontinence according the ICIQ-UI-Sf in comparison between baseline and follow-up
Description
The international Consultation of Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) is a validated questionnaire to asses urinary incontinence. Score 0-21, overall score with greater values indicating increased symptom severity
Time Frame
Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Change of overactive bladder symptoms according the ICIQ-OAB in comparison between baseline and follow-up
Description
The International Consultation of Incontinence Questionnaire - Overacitve bladder (ICIQ-OAB) is a validated questionnaire.. 0-16 overall score with greater values indicating increased symptom severity
Time Frame
Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
Title
Cure in short-, mid-, and longterm follow-up
Description
Number of patients accomplishing the composite outcome at remaining follow-up times
Time Frame
6 weeks and 6, 12, 36, 48, 60 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Non-fertile women > 18 years1 2. Symtomatic anterior prolapse with or without apical vaginal wall involvement according POP-Q score ≥ 2. (Corresponding to Aa, Ba ≥ -1 and where applicable C ≥ -1/2 TVL ). 3. Subjects with recurrent prolapse or complex primary prolapse are eligible for the study. 4. Scheduled mesh-augmented anterior POP repair with Calistar S 5. Signed inform consent Exclusion criteria Fertile women Patients with active or latent infection of the vagina, cervix or uterus Patients with previous or current vaginal, cervical or uterine cancer Previous, current or planned pelvic radiation therapy Known allergy to polypropylene 7. Subject is unable or unwilling to complete questionnaires (either self-administered, assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Schelhorn
Phone
00498031900400
Email
trials.de@promedon.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lorena Lopez, Ph.D, Bioeng
Phone
005493514502100
Email
lorena.lopez@promedon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gert Naumann, PD Dr.habil.
Organizational Affiliation
Helios Hospital Erfurt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralf Tunn, Prof.Dr.
Organizational Affiliation
St. Hedwig Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk Watermann, Prof.Dr.
Organizational Affiliation
Evangelic Diakonie Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Birgit Henne, Dr.med.
Organizational Affiliation
St. Elisabeth-Hospital Leipzig
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christl Reisenauer, Prof.Dr.med.
Organizational Affiliation
University Hospital Tübingen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Fünfgeld, Dr.med.
Organizational Affiliation
Hospital Tettnang
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Hospital Erfurt, Department of gynaecology
City
Erfurt
State/Province
Thüringen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gert Naumann, PD Dr.habil.
Facility Name
St. Hedwig Hospital
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Tunn, Prof.Dr.
Facility Name
Evangelic Diakonie Hospital
City
Freiburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Watermann, Prof. Dr.
Facility Name
St. Elisabeth-Hospital Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgit Henne, Dr.med.
Facility Name
Hospital Tettnang
City
Tettnang
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Fünfgeld, Dr.med.
Facility Name
University Hospital Tübingen
City
Tübingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christl Reisenauer, Prof.Dr.med.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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9083302
Citation
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Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair

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