Aim of the Study:This prospective, single-arm study is to evaluate the mid-term efficacy and safety of the Calistar S pelvic floor repair system for prolapse repair.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Background of the Study:
The surgical treatment of pelvic organ prolapse has significantly evolved over
the last few decades due to increased understanding of the anatomy as well as
the development of minimally invasive surgeries.
For the treatment of POP different surgical approaches are available. One
treatment option are vaginal implants, which are used in the anterior or
posterior vaginal wall, to induce a foreign body response. Vaginal meshes also
suspends the apex by a bilateral suspension of the vaginal vault or cervix to
both sacrospinous ligaments. Within this study the efficacy and safety of one
specific mesh is evaluated.
Study objective
Aim of the Study:
This prospective, single-arm study is to evaluate the mid-term efficacy and
safety of the Calistar S pelvic floor repair system for prolapse repair.
Study design
Studydesign:
This is a prospective, single-arm, multicenter study which is based on the
protocol. Within this study it is planned to include 179 Dutch patients which
are undergoing the POP-Treatment with Calistar S Prolapse Repair System.
Intervention
Calistar S for transvaginal pelvic organ prolapse repair.
Study burden and risks
The cumulative success after prolapse surgery in which a synthetic mesh is
implanted, is 93%. See chapter 10.3 of the protocol for more information.
Meibergdreef 9
Amsterdam 1100AZ
NL
Meibergdreef 9
Amsterdam 1100AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69695.100.20 |
| Other | NL9815 |