deltatrials
Completed NA INTERVENTIONAL 4-arm NCT00597935

Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial (OPTIMAL)

Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Interventions PMT SSLF ULS
Updated 8 times since 2017 Last updated: Oct 21, 2020 Started: Feb 29, 2008 Primary completion: Jul 31, 2013 Completion: Jul 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00597935, this NA trial focuses on Pelvic Organ Prolapse (POP) and remains completed. Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), it has been updated 8 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotCompleted~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Jan 2023 — Jul 2024 [monthly]

    Completed NA

  4. Dec 2022 — Jan 2023 [monthly]

    Completed NA

  5. Jan 2021 — Dec 2022 [monthly]

    Completed NA

Show 3 earlier versions
  1. Nov 2020 — Jan 2021 [monthly]

    Completed NA

    Phase: PHASE3NA

  2. Jun 2018 — Nov 2020 [monthly]

    Completed PHASE3

  3. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Feb 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • NICHD Pelvic Floor Disorders Network
Data source: NICHD Pelvic Floor Disorders Network

For direct contact, visit the study record on ClinicalTrials.gov .