Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
Primary Purpose
Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transvaginal suture capturing mesh device
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgery
Arm Description
Transvaginal suture capturing mesh device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01823055
First Posted
March 28, 2013
Last Updated
April 2, 2013
Sponsor
Karolinska Institutet
Collaborators
Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific
1. Study Identification
Unique Protocol Identification Number
NCT01823055
Brief Title
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
Official Title
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Arm Description
Transvaginal suture capturing mesh device
Intervention Type
Procedure
Intervention Name(s)
Transvaginal suture capturing mesh device
Other Intervention Name(s)
Uphold™ LITE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immediate and delayed complications related to the surgical procedure
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pelvic Organ Prolapse Quantification system
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
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