Cost-effectiveness Comparison Between Vaginal Versus Robotic Mesh Surgery for Apical Prolapse: Prospective, Cohort Study

NCT03878056 | Completed FDA Device

• 1 other identifier: Dnr: 2017/1988-31, 2018/380-32
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

Cost-effectiveness, safety, outcomes and diagnostic development in advanced apical female genital prolapse reconstructive surgery by vaginal and robotic-assisted mesh surgery. A multicenter, prospective, parallel, cohort, comparative study between the vaginal and robotic-assisted mesh surgery including 200 patients.

Conditions

Prolapse; Female

Outcome Measures

Primary Outcomes (1)

• Cost-effectiveness measurements and comparison between vaginal and robotic mesh surgery for apical prolapse

  Cost-effectiveness analysis: cost-effectiveness will be evaluated by comparing the vaginal approach with the robotic approach in term of incremental costs and incremental benefits (measured by QALYs gained).15 The incremental cost-effectiveness ratio (ICER) gives the marginal cost for each additional QALY gained by treating a patient using the robotic approach compared to the vaginal approach. To evaluate cost-effectiveness, the ICER must be compared with a reference willingness to pay (WTP) value. Sweden has no such official number, but the National Institute of Clinical Excellence (NICE) in the United Kingdom states a willingness to pay between 20,000 - 30,000 British pounds. If the ICER is below this threshold, the robotic approach will be considered cost-effective compared to the vaginal approach.

  Changes from baseline an up to 1, 5 and 10 years

Secondary Outcomes (11)

• Measurement of anatomical outcomes by Pelvic Organ Prolapse Quantification system (POP-Q): vaginal mesh utero-/colpopexy vs Robotic Sacral Colpopexy

  Changes from baseline an up to 3 months, 1, 5 and 10 years

• Measurement of generic quality of Life (QoL) by The 15D instrument of health-related quality of Life (15D): vaginal mesh utero-/colpopexy vs Robotic Sacral

  Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years

• Measurement of pelvic floor symptoms by Pelvic Floor Distress Inventory (PFDI-20): vaginal mesh utero-/colpopexy vs Robotic Sacral

  Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years

• Ultrasound measurement of mesh length in cm and mapping of mesh in correlation to bladder and urethra: vaginal mesh utero-/colpopexy vs Robotic Sacral

  Ultrasound measurements at 1, 5 and 10 years after surgery

• Measurement of generic QoL by health related quality of life by EuroQol 5-dimensions questionnaire (EQ-5D): vaginal mesh utero-/colpopexy vs Robotic Sacral

  Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years

Study Arms (2)

Transvaginal mesh

Vaginal surgery (UpholdTM Lite Vaginal Support, Boston Scientific)

Device: Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific

Robotic sacral colpopexy

Robotic surgery (Artisyn® Y-Shaped Mesh - Ethicon)

Device: Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific

Interventions

Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific DEVICE

Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy

Also known as: Robotic: Artisyn® Y-Shaped Mesh - Ethicon

Robotic sacral colpopexy; Transvaginal mesh

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Only women (female)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with apical prolapse and suffering prolapse symptoms.

You may qualify if:

• Posthysterectomy prolapse of the vaginal apex, with or without cystocele/rectocele, where the vaginal apex descends at least 50% of the total vaginal length
• Uterine prolapse, with or without cystocele/rectocele, 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/rectocele 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 without uterine prolapse.
• 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 severe diabetes mellitus
• Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis or rheumatic myalgia)
• Current systemic steroid treatment
• Other clinically relevant pelvic disorders for which surgery is indicated including stress urinary incontinence.
• Decision to perform prolapse surgery using other medical devices/mesh

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Morcos, MD, PhD

  Karolinska Institutet Danderyds Sjukhus (KIDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Head of Urogynecology

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 18, 2019
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: November 30, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-04

Locations

SE (1)