Clinical trial NCT03077490: Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device
Official title: Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolapse Genital
Keywords: Pelvic organ prolapse
transvaginal mesh
complications
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 319
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 112 patients from single center compared to 207 patients from 24 different centers

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.

Eligibility criteria: Inclusion

* 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
* No exclusion criteria fulfilled

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

Primary outcomes:
measure: The rate of immediate complications
timeFrame: From operation start to hospital discharge, assessed for an estimated total of days (1-7 days).
measure: Rate of delayed complications
timeFrame: From hospital discharge and up to 2 years at single center and 1 year at multicenter
Secondary outcomes:
measure: Anatomical outcomes
timeFrame: 2 years vs 1 year
measure: Subjective outcomes and sexual function
timeFrame: 2 years vs 1 year
measure: Ultrasound mapping of mesh position in the pelvic floor and correlation to anatomical and subjective outcomes and sexual function
timeFrame: 5, 7, 10 years
measure: Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale)
timeFrame: Changes from baseline, 2, 5 and 10 years after surgery
measure: Measurement of urinary incontinence by patient self-reporting Visual analogue scale (VAS-scale)
timeFrame: Changes from baseline, 2, 5 and 10 years after surgery
measure: Measurement of patient satisfaction by patient self-reporting Visual analogue scale (VAS-scale)
timeFrame: assessment at 2, 5 and 10 years after surgery
measure: 12. Measurement of patient recommendation to other patients to undergo same surgery with vaginal mesh if they suffer apical prolapse, assessed by patient self-reporting Visual analogue scale (VAS-scale)
timeFrame: assessment at 2, 5 and 10 years after surgery
Other outcomes:
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