Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device

Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele Clinical Trial

Official title:

Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823055
• Other study ID #: Karolinska Institutet
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: April 2, 2013
• Start date: January 2012

Study information

• Verified date: March 2013
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prolapse
• Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
• Uterine Prolapse

Intervention

Procedure:
• Transvaginal suture capturing mesh device
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	Yes
Secondary	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.	1 year	No