Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
Conditions
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.
Interventions
PROCEDURETransvaginal 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.
Sponsors
Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific
Karolinska Institutet
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate and delayed complications related to the surgical procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Quantification system | 1 year | 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. |
Outcome results
None listed