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Patientcentrerade resultat vid kirurgisk behandling av uterovaginalt framfall (PREMIER)

25 september 2026 uppdaterad av: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center

Patientcentrerade utfall av sakrokolpopexi kontra uterosakral ligamentupphängning för behandling av uterovaginalt framfall

The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women.

Studietyp

Interventionell

Inskrivning (Beräknad)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Florida
      • Jacksonville, Florida, Förenta staterna, 32224
        • Mayo Clinic
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern Medicine
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27707
        • Duke University
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Förenta staterna, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Förenta staterna, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • University of Pittsburgh, UPMC Magee-Womens Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  1. Women ≥ 18 years of age and ≤ 80 years of age
  2. Have diagnosis of symptomatic uterovaginal prolapse
  3. Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
  4. Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Exclusion Criteria:

  1. Patients who wish to undergo uterine sparing procedures
  2. Body mass index BMI) > 50
  3. Previous hysterectomy or prior uterovaginal surgery
  4. Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
  5. Chronic indwelling urinary catheter
  6. Urinary diversion of any type
  7. Any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
  8. Unable to speak, read, understand English

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Sacrocolpopexy

Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP)
Procedur: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)

Minimally invasive robotic or laparoscopic supracervical hysterectomy will be done, and the vaginal apex (including cervix) will be suspended utilizing sacrocolpopexy mesh to the anterior spinous ligament.
Aktiv komparator: Uterosacral Ligament Suspension

Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Procedur: Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment failure
Tidsram: 36 months post-surgery

The primary outcome is treatment failure defined as the presence of at least one of the following: 1) presence of a vaginal bulge defined as lead point of prolapse beyond the hymen, 2) report of bothersome vaginal bulge symptoms irrespective of stage of prolapse, or 3) retreatment of symptomatic prolapse with pessary, or surgery.
36 months post-surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative pain medication use
Tidsram: Post-surgery through Day 14

Postoperative pain medication use will be assessed using the total morphine equivalent dosing (MED) for narcotics and using the total dosage for non-narcotics.
Post-surgery through Day 14
Change in surgical pain using VAS
Tidsram: Baseline, Days 1, 7 and 14 post-surgery

Longitudinal pain score will be assessed using a visual analog scale (VAS) with a score of 0 to 100 where a higher score means a worse outcome.
Baseline, Days 1, 7 and 14 post-surgery
Postoperative anti-emetic use
Tidsram: Post-surgery through Day 14

Postoperative anti-emetic use will be assessed using the total number of times patients take an anti-emetic.
Post-surgery through Day 14
Change in nausea using VAS
Tidsram: Baseline, Days 1, 7 and 14 post-surgery

Longitudinal nausea score will be assessed using a visual analog scale (VAS) with a score of 0 to 100 where a higher score means a worse outcome.
Baseline, Days 1, 7 and 14 post-surgery
Change in fatigue using MAF
Tidsram: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery

Fatigue will be assessed utilizing the Multi-Dimensional Assessment of Fatigue (MAF) Scale with a score of 1 to 148 where a higher score means a worse outcome.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
Change in bladder function using UDI-6
Tidsram: Baseline, 2, 6, 12, 24, and 36 months post-surgery

Bladder function will be assessed using the Urinary Distress Inventory-6 (UDI-6) which is questions 15-20 of the Pelvic Floor Distress Inventory (PFDI-20) with a score of 0 to 18 where a higher score means a worse outcome.
Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in bladder function using IIQ-7
Tidsram: Baseline, 2, 6, 12, 24, and 36 months post-surgery

Bladder function will be assessed using the Incontinence Impact Questionnaire-7 (IIQ-7) with a score of 0 to 21 where a higher score means a worse outcome.
Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in bowel function using CRAD-8
Tidsram: Baseline, 2, 6, 12, 24, and 36 months post-surgery

Bowel function will be assessed using the Colorectal Anal Distress Inventory 8 (CRAD-8) which is questions 7-14 of the Pelvic Floor Distress Inventory (PFDI-20) with a score of 0 to 24 where a higher score means a worse outcome.
Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in sexual function using PISQ-12
Tidsram: Baseline, 6, 12, 24, and 36 months post-surgery

Sexual function will be assessed using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) with a score of 0 to 48 where a higher score means a worse outcome.
Baseline, 6, 12, 24, and 36 months post-surgery
Change in sexual function using FSFI
Tidsram: Baseline, 6, 12, 24, and 36 months post-surgery

Sexual function will be assessed using the Female Sexual Function Inventory (FSFI) with a score of 2 to 36 where higher score where a higher score means a better outcome.
Baseline, 6, 12, 24, and 36 months post-surgery
Change in body image using BIPOP
Tidsram: Baseline, 6, 12, 24, and 36 months post-surgery

Body image will be assessed using the Body Image in Pelvic Organ Prolapse Questionnaire (BIPOP) with a score of 1 to 5 where a higher score means a better outcome.
Baseline, 6, 12, 24, and 36 months post-surgery
Change in quality of life using P-QOL
Tidsram: Baseline, 2, 6, 12, 24, and 36 months post-surgery

General quality of life will be assessed using the Pelvic Organ Prolapse Quality of Life Questionnaire (P-QOL) with a score in each domain of 0 to 100 where a higher score means a worse outcome.
Baseline, 2, 6, 12, 24, and 36 months post-surgery
Change in satisfaction with care using PGI-I
Tidsram: Baseline, 6, 12, 24, and 36 months post-surgery

Satisfaction with care will be assessed using the Patient Global Impression of Improvement (PGI-I) scale with a score of 1 to 7 where higher score means a worse outcome.
Baseline, 6, 12, 24, and 36 months post-surgery
Rate of Grade I-V DINDO complications in each surgical arm
Tidsram: Surgery through 36 months post-surgery

Surgical complications will be assessed using the Clavien-Dindo standardized classification system with a grade of I to V where the higher grade means a worse outcome.
Surgery through 36 months post-surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospitals Cleveland Medical Center

Samarbetspartners

Mayo Clinic
University of Pittsburgh
The Cleveland Clinic
Duke University
Case Western Reserve University
MetroHealth Medical Center
Northwestern Medicine

Utredare

  • Huvudutredare: Adonis Hijaz, MD, University Hospitals Cleveland Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 december 2021

Primärt slutförande (Beräknad)

31 maj 2029

Avslutad studie (Beräknad)

31 maj 2029

Studieregistreringsdatum

Först inskickad

4 augusti 2021

Först inskickad som uppfyllde QC-kriterierna

29 september 2021

Första postat (Faktisk)

1 oktober 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20210871

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

All of the individual participant data collected during the trial will be made available after de-identification.

Tidsram för IPD-delning

Beginning 9 months and ending 36 months following publication.

Kriterier för IPD Sharing Access

Researchers who provide a methodologically sound proposal may use the data for any purpose.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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