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

NCT ID: NCT03077490

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 319 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-04
• Study Completion Date: 2017-02-01

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.

Detailed Description

112 women operated by two surgeons at one center (2 years follow up) are to be compared to 207 women operated by twenty six surgeons at twenty four centers (1 year follow-up).

Screening at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior or vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system.

Surgical data including operation data, complications and hospital stay are to be compared.

Anatomical outcome measurements by POP-Q evaluations. Subjective symptoms are to be evaluated by prolapse specific symptom questionnaires (PFIQ-7, UDI-6 and PFIQ) whereas sexual function to be estimated by PISQ-12.

Conditions

Prolapse Genital

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Single center vs. multicenter

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

Transvaginal mesh Uphold TM Vaginal Support System

Intervention Type: DEVICE

Transvaginal mesh Uphold TM Vaginal Support System.

Intervention Type: DEVICE

Interventions

Transvaginal mesh Uphold TM Vaginal Support System

Intervention Type: DEVICE

Transvaginal mesh Uphold TM Vaginal Support System.

Intervention Type: DEVICE

Other Intervention Names

Transvaginal mesh Uphold TM Vaginal Support System.

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Edward Morcos

Senior consultant, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Protokoll Dnr 2015/5: 3

Identifier Type: -

Identifier Source: org_study_id