Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device

NCT03077490 | Completed FDA Device

• 1 other identifier: Protokoll Dnr 2015/5: 3
• Study Type: observational
• Target: 319
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prolapse Genital

Keywords

Pelvic organ prolapse; transvaginal mesh; complications

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From hospital discharge and up to 2 years at single center and 1 year at multicenter

Secondary Outcomes (7)

• Anatomical outcomes

  2 years vs 1 year

• Subjective outcomes and sexual function

  2 years vs 1 year

• Ultrasound mapping of mesh position in the pelvic floor and correlation to anatomical and subjective outcomes and sexual function

  5, 7, 10 years

• Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale)

  Changes from baseline, 2, 5 and 10 years after surgery

• Measurement of urinary incontinence by patient self-reporting Visual analogue scale (VAS-scale)

  Changes from baseline, 2, 5 and 10 years after surgery

Study Arms (1)

Single center vs. multicenter

Both Groups operated on by the same device (Transvaginal mesh Uphold TM Vaginal Support System) and in the same manner.

Device: Transvaginal mesh Uphold TM Vaginal Support System; Device: Transvaginal mesh Uphold TM Vaginal Support System.

Interventions

Transvaginal mesh Uphold TM Vaginal Support System. DEVICE

Single center vs. multicenter

Eligibility Criteria

• Age: 18 Years - 90 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

112 patients from single center compared to 207 patients from 24 different centers

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, MD, PhD

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: March 13, 2017
• Study Start: March 4, 2015
• Primary Completion: March 30, 2016
• Study Completion: February 1, 2017
• Last Updated: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share