NCT02800512

Brief Summary

The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

9 years

First QC Date

April 26, 2016

Last Update Submit

January 2, 2025

Conditions

Pelvic Organ ProlapseCystoceleRectoceleEnterocele

Keywords

pelvic organ prolapsecystocelerectoceleenterocele

Outcome Measures

Primary Outcomes (3)

  • Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively

    Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

    3 month post operative

  • Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively

    Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

    6 month post operative

  • Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively

    Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

    12 month post operative

Secondary Outcomes (8)

  • questionnaires PFDI-7

    6 month post operative

  • questionnaires PFDI-7

    12 month post operative

  • questionnaires PFIQ-20

    6 month post operative

  • questionnaires PFIQ-20

    12 month post operative

  • questionnaires PISQ-12

    6 month post operative

  • +3 more secondary outcomes

Study Arms (2)

Sacrocolpopexy

ACTIVE COMPARATOR

Robotic sacrocolpopexy

Procedure: Robotic sacrocolpopexy

HUSLS

ACTIVE COMPARATOR

Vaginal high uterosacral ligament suspension

Procedure: high uterosacral ligament suspension

Interventions

Robotic sacrocolpopexyPROCEDURE

Sacrocolpopexy is a procedure to surgically correct vaginal vault prolapse where mesh is used to hold the vagina in the correct anatomical position. Robotic assistance is a minimally invasive method to perform this abdominal procedure.

Also known as: R-SCP
Sacrocolpopexy
high uterosacral ligament suspensionPROCEDURE

Utilizing uterosacral ligaments to support the vaginal cuff can be performed vaginally-by passing sutures bilaterally through the uterosacral ligaments. near the level of the ischial spine. HUSLS is a vaginal minimally invasive procedure for POP.

Also known as: HUSLS
HUSLS

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years of age or older
  • Signed Informed Consent
  • Symptomatic pelvic organ prolapse,
  • Willing and able to complete all study visit

You may not qualify if:

  • Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery),
  • Dementia or considered unable to complete questionnaires
  • Hx of Alzheimer Disease
  • Hx multiple strokes or other neurologic condition
  • Caregiver states the subject is unable to complete
  • MDs opinion
  • Inability to complete follow up visits due to transportation issues
  • No access to transportation (ie. does not have vehicle)
  • Live \> 2 hours from LLUH
  • Does not have financial means
  • Congenital anomalies
  • Bladder Exstrophy
  • Connective tissue disease
  • Neovaginal prolapse
  • Prolapse of sex change vagina
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University URO/GYN

Loma Linda, California, 92354, United States

Location

Related Publications (2)

  • Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J Urol. 2006 Aug;176(2):655-9. doi: 10.1016/j.juro.2006.03.040.

    PMID: 16813916BACKGROUND

  • Margulies RU, Rogers MA, Morgan DM. Outcomes of transvaginal uterosacral ligament suspension: systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Feb;202(2):124-34. doi: 10.1016/j.ajog.2009.07.052.

    PMID: 20113690BACKGROUND

MeSH Terms

Conditions

Pelvic Organ ProlapseCystoceleRectoceleHernia

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Sam Siddighi

    Loma Linda University Health Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

June 15, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)