anterior Prolaps Cystocele
Conditions
Interventions
Calistar S for transvaginal pelvic organ prolapse repair.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Women >= 18 years old 2. Postmenopausal status and / or post-hysterectomy and / or sterilised 3. Either anterior or combined anterior and apical vaginal prolapse according POP-Q score >= 2. Corresponding to Ba >= -1; or Ba >= -1 and C >= -1/2 TVL. 4. Subjects with recurrent prolapse as well as primary prolapse with high risk for recurrence are eligible for the study. 5. Subject should be symptomatic regarding pelvic organ prolapse
Exclusion criteria
Exclusion criteria: 1. History of pelvic implant (biological graft or mesh augmented repair) (Prior suburethral sling for treatment of stress urinary incontinence is allowed) 2. Local or systemic active or latent infection and/or signs of tissue necrosis 3. Current pregnancy or planned pregnancy (no completion of family planning) 4. History of pelvic radiation therapy 5. Immune compromised or medication which could result in compromised immune response (e.g. immune modulators, antirheumatic medication) 6. Sensitivity/Allergy to polypropylene 7. Intended simultaneous procedure to treat stress urinary incontinence 8. Current or history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical); 9. Presence of chronic pelvic pain syndromes or other systemic pain syndromes (e.g. fibromyalgia) 10. Presence of neurologic or medical condition affecting urinary bladder function (e.g. Multiple sclerosis, spinal cord injury, stroke with residual neurologic deficit, etc) 11. Current anticoagulant therapy which can not be temporarily bridged or stopped 12. Ulcus of the vaginal wall. 13. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success according to 1: lowest point POP <= 1, 2: no subjective bothersome symptoms (PFDI Questionnaire), 3: no re-intervention) in the respective compartment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: 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). 1. Quality of Life (QoL-Status) 2. Operation Time 3. Rate of the vaginal erosion because of the Calistar S mesh insertion. 4. Frequency, beginning and type of new or worsening urinary incontinence 5. Interval POP-Q Staging 6. Indication of pain in the pelvic area associated with the performed mesh insertion 7. Satisfaction of the subjects 8. Frequency of the necessary surgical revisions of the Calistar S mesh implant 9. Adverse events / complications. | — |
Countries
Netherlands
Outcome results
None listed