- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03077490
Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device (KIDS)
Study Overview
Status
Conditions
Detailed Description
112 women operated by two surgeons at one center (2 years follow up) are to be compared to 207 women operated by twenty six surgeons at twenty four centers (1 year follow-up).
Screening at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior or vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system.
Surgical data including operation data, complications and hospital stay are to be compared.
Anatomical outcome measurements by POP-Q evaluations. Subjective symptoms are to be evaluated by prolapse specific symptom questionnaires (PFIQ-7, UDI-6 and PFIQ) whereas sexual function to be estimated by PISQ-12.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion
- Posthysterectomy prolapse of the vaginal apex, with or without cystocele, where the vaginal apex descends at least 50% of the total vaginal length
- Uterine prolapse, with or without cystocele, where the leading edge of the cervix descends at least 50% of the total vaginal length and TVL minus point C= ≤ 2 cm
- Prolapse specific pelvic symptom of pelvic heaviness and/or vaginal bulging
- Reproductive years in the past (biologically or reproductive decision)
- Being able to make an informed consent on participation
- Physically and cognitively capable of participating in the required follow-up
- No exclusion criteria fulfilled
Exclusion Criteria:
- Posthysterectomy prolapse of the vaginal apex where the vaginal apex descends less than 50% of the total vaginal length regardless of whether a cystocele is present or not
- Uterine prolapse, with or without cystocele, where the leading edge of the cervix descends less than 50% of the total vaginal length
- If cervix elongation is present corresponding to: TVL minus point C= >2 cm.
- If prolapse specific pelvic symptoms of pelvic heaviness and/or vaginal bulging are not present
- Previous or current pelvic organ cancer (regardless of treatment)
- Severe rheumatic disease
- Insulin treated diabetes mellitus
- Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Dahnlos, collagenosis, polymyositis eller rheumatic myalgia)
- Current systemic steroid treatment
- Other clinically relevant pelvic disorders for which surgery is indicated including stress urinary incontinence, cervix elongation and posterior prolapse
- Decision to perform prolapse surgery using other medical devices/mesh
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Single center vs. multicenter
Both Groups operated on by the same device (Transvaginal mesh Uphold TM Vaginal Support System) and in the same manner.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of immediate complications
Time Frame: From operation start to hospital discharge, assessed for an estimated total of days (1-7 days).
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Serious surgical complications are categorized as any surgical event which is potentially life-threatening related to the surgical procedure including: internal organ perforation (or other injury), bleeding in excess of 1000 mL.
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From operation start to hospital discharge, assessed for an estimated total of days (1-7 days).
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Rate of delayed complications
Time Frame: From hospital discharge and up to 2 years at single center and 1 year at multicenter
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Adverse events during follow-up which requires re-hospitalisation or surgical re-intervention.
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From hospital discharge and up to 2 years at single center and 1 year at multicenter
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anatomical outcomes
Time Frame: 2 years vs 1 year
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Anatomical outcome is a composite definition including point C positioned above a point corresponding to half of the total vaginal length.
The overall POP-Q outcomes will be analyzed to determine efficacy of the procedure related to correction of anterior prolapse ≥stage II or other defects present at the time of surgery.
Days in hospital are counted from the day of surgery i.e. the day of operation is day 1 and the day of returning home is the last day of hospital stay.
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2 years vs 1 year
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Subjective outcomes and sexual function
Time Frame: 2 years vs 1 year
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Subjective outcome is the patients' response 'no' to question 2 of the PFDI (pelvic heaviness).
The composite outcome is a strictly binary categorization where any residual sense of pelvic heaviness/vaginal bulging results in the classification of the patient as a failure.
It also includes the components of the main secondary outcome considered individually, any adverse events in the aftermath of surgery, as well as, patient-reported urogenital distress (UDI), quality of life (PFIQ) and sexual function (PISQ-12) as measured by the self-reported questionnaires.
For secondary analyses, the ordinal grading of responses to the PFDI-20, PFIQ-7 and PISQ-12 will be used to determine rates of improvement and progression over time.
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2 years vs 1 year
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Ultrasound mapping of mesh position in the pelvic floor and correlation to anatomical and subjective outcomes and sexual function
Time Frame: 5, 7, 10 years
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Mesh measurements: Total mesh midsagittal length, length above and below the bladder neck (BN) level. Distance between mesh lower edge and pubis symphysis (PS) lower edge and PS level. Bladder neck: Distance between BN and PS levels. Distance between BN and PS lower edge. Urethra: Total urethra length. Distance between mid-urethra and PS lower edge and PS level. Using identical examination protocol, independent examination at rest and physical strain is to be done by senior gynecologist at an ultrasound referral unit and gynecologist. Estimation of intra class coefficient (ICC) in-between examiners in order to determine method reproducibility. To statistically compare between the collected ultrasound data and clinical outcomes. Clinical outcomes include anatomical, subjective and sexual function outcome. |
5, 7, 10 years
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Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale)
Time Frame: Changes from baseline, 2, 5 and 10 years after surgery
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VAS scale is a numeric rating scale and ranges from 0-10 (each digit is 1cm) where 0 indicates no and 10 indicates maximum, digits between 0-10 indicate degree of pain.
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Changes from baseline, 2, 5 and 10 years after surgery
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Measurement of urinary incontinence by patient self-reporting Visual analogue scale (VAS-scale)
Time Frame: Changes from baseline, 2, 5 and 10 years after surgery
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VAS scale is a numeric rating scale and ranges from 0-10 (each digit is 1cm) where 0 indicates no and 10 indicates maximum, digits between 0-10 indicate degree of severity of urinary incontinence.
VAS scale for urinary incontinence: 0 indicate no urinary incontinence whereas 10 indicates maximal or severe urinary incontinence.
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Changes from baseline, 2, 5 and 10 years after surgery
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Measurement of patient satisfaction by patient self-reporting Visual analogue scale (VAS-scale)
Time Frame: assessment at 2, 5 and 10 years after surgery
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VAS scale is a numeric rating scale and ranges from 0-10 (each digit is 1cm) where 0 indicates no and 10 indicates maximum, digits between 0-10 indicate degree of satisfaction after mesh surgery.
VAS scale for patient satisfaction: 0 indicates no satisfaction whereas 10 indicates maximal satisfaction.
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assessment at 2, 5 and 10 years after surgery
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12. Measurement of patient recommendation to other patients to undergo same surgery with vaginal mesh if they suffer apical prolapse, assessed by patient self-reporting Visual analogue scale (VAS-scale)
Time Frame: assessment at 2, 5 and 10 years after surgery
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VAS scale is a numeric rating scale and ranges from 0-10 (each digit is 1cm) where 0 indicates no and 10 indicates maximum, digits between 0-10 indicate degree of satisfaction.
VAS scale for patient recommendation to other patients to undergo same surgery if they suffer apical prolapse: 0 indicates no recommendation whereas 10 indicates maximal recommendation.
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assessment at 2, 5 and 10 years after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protokoll Dnr 2015/5: 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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