Prolapse GenitalKIDSNCT03077490
Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device
An observational study of Prolapse Genital, run by Karolinska Institutet.
Trial summary
Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Prolapse Genital
- What is being tested?
- Transvaginal mesh Uphold TM Vaginal Support System and Transvaginal mesh Uphold TM Vaginal Support System.
- Type of treatment
- Medical device
- How many people
- 319 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2015to 1 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Adult, Older adult
Study population: 112 patients from single center compared to 207 patients from 24 different centers
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.
Read the 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.
- Conditions
- Prolapse Genital
- Being tested
- Transvaginal mesh Uphold TM Vaginal Support System, Transvaginal mesh Uphold TM Vaginal Support System.
- Keywords
- Pelvic organ prolapse, transvaginal mesh, complications
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal mesh Uphold TM Vaginal Support SystemDevice
Also called Transvaginal mesh Uphold TM Vaginal Support System.
Transvaginal mesh Uphold TM Vaginal Support System.Device
| Study group | Role | What they receive |
|---|---|---|
| Single center vs. multicenter | Both Groups operated on by the same device (Transvaginal mesh Uphold TM Vaginal Support System) and in the same manner. Receives: Device: Transvaginal mesh Uphold TM Vaginal Support System; Device: Transvaginal mesh Uphold TM Vaginal Support System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of immediate complications
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.
Measured: From operation start to hospital discharge, assessed for an estimated total of days (1-7 days).
Rate of delayed complications
Adverse events during follow-up which requires re-hospitalisation or surgical re-intervention.
Measured: From hospital discharge and up to 2 years at single center and 1 year at multicenter
Secondary outcomes (7)
Anatomical outcomes
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.
Measured: 2 years vs 1 year
Subjective outcomes and sexual function
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.
Measured: 2 years vs 1 year
Ultrasound mapping of mesh position in the pelvic floor and correlation to anatomical and subjective outcomes and sexual function
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.
Measured: 5, 7, 10 years
Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale)
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.
Measured: Changes from baseline, 2, 5 and 10 years after surgery
Measurement of urinary incontinence by patient self-reporting Visual analogue scale (VAS-scale)
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.
Measured: Changes from baseline, 2, 5 and 10 years after surgery
Measurement of patient satisfaction by patient self-reporting Visual analogue scale (VAS-scale)
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.
Measured: assessment at 2, 5 and 10 years after surgery
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)
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.
Measured: assessment at 2, 5 and 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start4 Mar 2015
- Primary completion30 Mar 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolapse GenitalStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Morcos, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077490
- Sponsor's protocol ID
- Protokoll Dnr 2015/5: 3
- Acronym
- KIDS
- Status last verified
- Oct 2019
- First submitted
- 1 Feb 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device
- ClinicalTrials.gov ID
- NCT03077490
- Acronym / sponsor ID
- KIDS / Protokoll Dnr 2015/5: 3
- Conditions
- Prolapse Genital
- Keywords
- Pelvic organ prolapse, transvaginal mesh, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 4 Mar 2015 (actual)
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single center vs. multicenter | – | Device: Transvaginal mesh Uphold TM Vaginal Support System, Device: Transvaginal mesh Uphold TM Vaginal Support System.Both Groups operated on by the same device (Transvaginal mesh Uphold TM Vaginal Support System) and in the same manner. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- 112 patients from single center compared to 207 patients from 24 different centers
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal mesh Uphold TM Vaginal Support SystemAlso: Transvaginal mesh Uphold TM Vaginal Support System. | Device | Single center vs. multicenter |
| Transvaginal mesh Uphold TM Vaginal Support System. | Device | Single center vs. multicenter |
Primary outcome
The rate of immediate complications
Time frame: From operation start to hospital discharge, assessed for an estimated total of days (1-7 days).
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.
Rate of delayed complications
Time frame: From hospital discharge and up to 2 years at single center and 1 year at multicenter
Adverse events during follow-up which requires re-hospitalisation or surgical re-intervention.
7 secondary outcomes
Anatomical outcomes
Time frame: 2 years vs 1 year
Subjective outcomes and sexual function
Time frame: 2 years vs 1 year
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
Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale)
Time frame: Changes from baseline, 2, 5 and 10 years after surgery
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
Measurement of patient satisfaction by patient self-reporting Visual analogue scale (VAS-scale)
Time frame: assessment at 2, 5 and 10 years after surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolapse Genital, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of immediate complications (time frame: From operation start to hospital discharge, assessed for an estimated total of days (1-7 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.