Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without CystoceleNCT01823055
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
A study testing Transvaginal suture capturing mesh device in people with Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele, run by Karolinska Institutet.
Trial summary
To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
- What is being tested?
- Transvaginal suture capturing mesh device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2013
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification [POP-Q] system)9,
- with or without anterior vaginal wall prolapse, and
- experiences symptoms of vaginal bulging with or without a previous hysterectomy
- being able to provide oral and written informed consent before entering the study.
Who cannot join
- previous cancer of any pelvic organ,
- systemic glucocorticoid treatment,
- insulin-treated diabetes,
- an inability to participate in study follow-up or to provide informed consent, or
- the need for any concomitant pelvic surgery.
About this study
Official title: Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial
To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.
- Being tested
- Transvaginal suture capturing mesh device
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal suture capturing mesh deviceProcedure or surgery
Also called Uphold™ LITE
The Uphold™ LITE vaginal support system is an intra-vaginal approach to apical and anterior vaginal wall prolapse repair that utilizes a suture capturing device to place the mesh. After primary dissection the suturing device is used to pull the mesh through the sacrospinous ligament, medial to the ischial spine. An anterior colporraphy was allowed following the Uphold™ LITE procedure at the discretion of the surgeon if deemed necessary.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Transvaginal suture capturing mesh device Receives: Procedure: Transvaginal suture capturing mesh device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate and delayed complications related to the surgical procedure
Serious surgical complications are categorised as any surgical event which is potentially life-threatening, internal organ perforation (or other injury), bleeding in excess of 1000 mL or adverse events, related to the surgical procedure, during follow-up which requires re-hospitalisation.
Measured: 1 year
Secondary outcomes (1)
Pelvic Organ Prolapse Quantification system
The secondary efficacy outcome is a composite of objective and subjective measures including POP-Q stage 0 or 1 of the upper vaginal segment (i.e., point C/D, which represents the most distal point of the vaginal apex in relation to the total vaginal length) and a negative response to the question, "Do you experience a feeling of bulging or protrusion in the vaginal area?" (question 16 on the UDI). The secondary outcome measures further include the individual components of the composite end point, other POP-Q measurements and patient-reported urogenital distress.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without CystoceleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific
- Responsible party
- Principal investigator, Daniel Altman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823055
- Sponsor's protocol ID
- Karolinska Institutet
- Status last verified
- Mar 2013
- First submitted
- 28 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial
- ClinicalTrials.gov ID
- NCT01823055
- Acronym / sponsor ID
- Karolinska Institutet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- First posted
- 4 Apr 2013 (estimated)
- 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.
To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Transvaginal suture capturing mesh deviceTransvaginal suture capturing mesh device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification [POP-Q] system)9,
- with or without anterior vaginal wall prolapse, and
- experiences symptoms of vaginal bulging with or without a previous hysterectomy
- being able to provide oral and written informed consent before entering the study.
Key exclusion criteria (5 listed)
- previous cancer of any pelvic organ,
- systemic glucocorticoid treatment,
- insulin-treated diabetes,
- an inability to participate in study follow-up or to provide informed consent, or
- the need for any concomitant pelvic surgery.
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 suture capturing mesh deviceAlso: Uphold™ LITEThe Uphold™ LITE vaginal support system is an intra-vaginal approach to apical and anterior vaginal wall prolapse repair that utilizes a suture capturing device to place the mesh. After primary dissection the suturing device is used to pull the mesh through the sacrospinous ligament, medial to the ischial spine. An anterior colporraphy was allowed following the Uphold™ LITE procedure at the discretion of the surgeon if deemed necessary. | Procedure or surgery | Surgery |
Primary outcome
Immediate and delayed complications related to the surgical procedure
Time frame: 1 year
Serious surgical complications are categorised as any surgical event which is potentially life-threatening, internal organ perforation (or other injury), bleeding in excess of 1000 mL or adverse events, related to the surgical procedure, during follow-up which requires re-hospitalisation.
1 secondary outcome
Pelvic Organ Prolapse Quantification system
Time frame: 1 year
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 4 Apr 2013.
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?
A study testing Transvaginal suture capturing mesh device in people with Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele, 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 4 inclusion and 5 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 4 Apr 2013. 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?
Immediate and delayed complications related to the surgical procedure (time frame: 1 year). 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 4 Apr 2013.