Mid-term evaluation of the efficacy and safety of the Calistar S pelvic floor repair system for prolapse repair.
- Conditions
- Pelvic Organ ProlapsAnterior and/or apical ProlapsCystoceleBekkenbodem verzakkingAnterieure en / of apicale verzakkingcystocele
- Registration Number
- NL-OMON20957
- Lead Sponsor
- Promedon GmbH
- Brief Summary
no publications yet
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 165
To be eligible to participate in this study, a subject must meet all of the following criteria:
| 1. Subject is female
| 2. Post-menopausal status of the subject
| 3. Subject has documented diagnosis of anterior or anterior and apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba = 0; or Ba = 0 and C = -1/2 TVL.
| 4. Both subjects with primary and secondary cases are eligible for the study. In case of primary occurrence of prolapse subjects must at least fulfill two risk criteria according to the current IUGA recommendations (listed in point 10.2.2.1. of the protocol).
| 5. Subject should report bothersome or very bothersome prolapse symptoms (PFDI Question 3 = 2)
A potential subject who meets any of the following criteria will be excluded from
participation in this study:
| 1. Subject has had a prior prolapse implant / procedure (graft augmented repair) (previous sling therapy is allowed)
| 2. Subject has active or latent systemic infection or signs of tissue necrosis.
| 3. Subject is currently pregnant or intends to become pregnant in the future.
| 4. Subject has had radiation therapy to the pelvic area.
| 5. Subject is on any medication which could result in compromised immune response, such as immune modulators and antirheumatic medication.
| 6. Subjects who are not capable of giving informed consent;
| 7. Subject has a known sensitivity to polypropylene;
| 8. Subject has an indication for a concomitant procedure to treat SUI;
| 9. Subject is known with pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical);
| 10. Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis;
| 11. Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit).
| 12. Subject is undergoing anticoagulant therapy (The anticoagulant medication should be discontinued / bridged for the operation in accordance with the hospital guidelines)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure according to Barber criteria (that means meeting 3 conditions: 1: lowest point POP = 1, 2: no subjective bothersome symptoms (PFDI Questionnaire), 3: no re-intervention) one year post procedure.
- Secondary Outcome Measures
Name Time Method To evaluate objective and subjective variables of the implantation (e.g. operating time, surgical performance), mid-term safety (e.g. adverse events) and outcomes (e.g. sexual function). <br>1.Quality of Life (QoL-Status) <br>2.Operation Time <br>3.Rate of the vaginal erosion because of the Calistar S mesh insertion. <br>4.Frequency, beginning and type of new or worsening urinary incontinence<br>5.Interval POP-Q Staging<br>6.Indication of pain in the pelvic area associated with the performed mesh insertion<br>7.Satisfaction of the subjects<br>8.Frequency of the necessary surgical revisions of the Calistar S mesh implant