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

N/AActive Not RecruitingNCT03821142

Promedon180 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Pelvic Organ Prolapse

Interventions

Transvaginal mesh for anterior pelvic organ prolapse repairDEVICE

synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Helios Hospital Erfurt, Department of gynaecology

Erfurt, Thuringia, Germany

St. Hedwig Hospital

Berlin, Germany

Evangelic Diakonie Hospital

Freiburg im Breisgau, Germany

St. Elisabeth-Hospital Leipzig

Leipzig, Germany

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

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.

Time frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months

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.

Time frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months

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.

Time frame: Baseline, 24-48h postoperatively, 6 weeks and 6, 12, 24, 36, 48, 60 months

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,

Data from ClinicalTrials.gov

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