Prospective, multicenter, 36 months, comparative matched cohort study to evaluate the efficacy and safety of the ultra-lightweight mesh CAlistar S in transvaginal Pelvic Organ Prolapse repair

Recruiting

• Conditions: anterior Prolaps; Cystocele; 10046828

• Registration Number: NL-OMON54988
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 179

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Surgical success according to<br /><br>1: lowest point POP <= 1,<br /><br>2: no subjective bothersome symptoms (PFDI Questionnaire),<br /><br>3: no re-intervention) in the respective compartment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br>To evaluate objective and subjective variables of the implantation (e.g.<br /><br>operating time, surgical performance), mid-term safety (e.g. adverse events)<br /><br>and outcomes (e.g. sexual function).<br /><br>1. Quality of Life (QoL-Status)<br /><br>2. Operation Time<br /><br>3. Rate of the vaginal erosion because of the Calistar S mesh insertion.<br /><br>4. Frequency, beginning and type of new or worsening urinary incontinence<br /><br>5. Interval POP-Q Staging<br /><br>6. Indication of pain in the pelvic area associated with the performed mesh<br /><br>insertion<br /><br>7. Satisfaction of the subjects<br /><br>8. Frequency of the necessary surgical revisions of the Calistar S mesh implant<br /><br>9. Adverse events / complications.</p><br>