Clinical trial NCT03821142: Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: surgical mesh
surgery
Therapy
pelvic floor disorders
cystocele
Lead sponsor: Promedon
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Calistar S Single Incision POP System
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Number of Patients with Cure of pelvic organ prolapse
timeFrame: 24 months
Secondary outcomes:
measure: Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up
timeFrame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: Change of sexual life according the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire in comparison between Baseline and follow-up
timeFrame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: Change of pain according Visual Analog Scale of Pain in comparison between baseline, postoperative and follow-up
timeFrame: Baseline, 24-48h postoperatively, 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: Patients subjective evaluation of satisfaction with surgery according the Patient Global Impression of Improvement
timeFrame: 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: Patient subjective evaluation of POP severity according the Global Impression of Severity
timeFrame: Baseline
measure: Change of quality of life according the EQ-5L-5D in comparison between baseline and follow-up
timeFrame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: 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
timeFrame: 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: 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
timeFrame: 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: Safety of Calistar S according the number of adverse events
timeFrame: intraoperative, postoperative, 6 weeks, and 6, 12, 24, 36, 48, 60 months and unscheduled visits
measure: Exposure and anatomical-failure free survival
timeFrame: 12, 24, 36, 48, 60 months
measure: Number of patients with further surgery for stress urinary incontinence
timeFrame: 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: Change of urinary incontinence according the ICIQ-UI-Sf in comparison between baseline and follow-up
timeFrame: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: Change of overactive bladder symptoms according the ICIQ-OAB in comparison between baseline and follow-up
timeFrame: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
measure: Cure in short-, mid-, and longterm follow-up
timeFrame: 6 weeks and 6, 12, 36, 48, 60 months
Other outcomes:
Locations:
city: Erfurt
country: Germany
facility: Helios Hospital Erfurt, Department of gynaecology
state: Thüringen
city: Berlin
country: Germany
facility: St. Hedwig Hospital
city: Freiburg
country: Germany
facility: Evangelic Diakonie Hospital
city: Leipzig
country: Germany
facility: St. Elisabeth-Hospital Leipzig
city: Tettnang
country: Germany
facility: Hospital Tettnang
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: Helios Hospital Erfurt
name: Gert Naumann, PD Dr.habil.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Hedwig Hospital
name: Ralf Tunn, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Evangelic Diakonie Hospital
name: Dirk Watermann, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Elisabeth-Hospital Leipzig
name: Birgit Henne, Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tübingen
name: Christl Reisenauer, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Tettnang
name: Christian Fünfgeld, Dr.med.
role: PRINCIPAL_INVESTIGATOR
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