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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Office of Research on Women's Health (ORWH)
Information provided by (Responsible Party):
Susan Meikle, MD MSPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00597935
First received: January 9, 2008
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:

  1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and
  2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.

Condition Intervention Phase
Pelvic Organ Prolapse
 Procedure: SSLF
Procedure: ULS
Behavioral: PMT
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • For the surgical intervention: surgical "success" or "failure" is defined by: (1)an anatomic assessment of prolapse, and (2)the presence or absence of bulge symptoms specific to prolapse [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • For Pelvic Muscle Therapy: urinary symptoms as measured by the UDI of the PFDI [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
  • For Pelvic Muscle Therapy: prolapse symptoms as measured by the POPDI subscale of the PFDI and anatomic outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 439
Study Start Date: February 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SSLF and PMT
 Procedure: SSLF
sacrospinous ligament fixation (SSLF)
Behavioral: PMT
Pelvic muscle training and exercises (PMT)
Experimental: 2
ULS and PMT
 Procedure: ULS
uterosacral vaginal vault ligament suspension (ULS)
Behavioral: PMT
Pelvic muscle training and exercises (PMT)
Experimental: 3
SSLF without PMT
 Procedure: SSLF
sacrospinous ligament fixation (SSLF)
Experimental: 4
ULS without PMT
 Procedure: ULS
uterosacral vaginal vault ligament suspension (ULS)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 2 to 4 prolapse
  • Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C > -TVL/2)
  • Vaginal bulge symptoms as indicated by an affirmative response to either questions on the PFDI
  • Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.
  • Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale
  • Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months
  • A TVT is planned to treat stress urinary incontinence.
  • A PMT visit can be performed at least 2 weeks and not more than 4 weeks before surgery.
  • Available for 24-months of follow-up.
  • Able to complete study assessments, per clinician judgment
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Contraindication to SSLF, ULS, or TVT in the opinion of the treating surgeon.
  • History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.)
  • Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.
  • History of previous synthetic sling procedure for stress incontinence.
  • Previous adverse reaction to synthetic mesh.
  • Urethral diverticulum, current or previous (i.e., repaired)
  • History of femoral to femoral bypass.
  • Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.
  • History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.
  • Subject wishes to retain her uterus. [Both ULS and SLS include removal of the uterus, if not previously removed]
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597935

Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233-7333
United States, California
Kaiser Permanente Bellflower
Bellflower, California, United States, 90706
University of California, San Diego Medical Center
La Jolla, California, United States, 92037
Kaiser Permanente
San Diego, California, United States, 92120
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Office of Research on Women's Health (ORWH)
Investigators
Principal Investigator: Matthew Barber, MD The Cleveland Clinic
  More Information

Additional Information:
Pelvic Floor Disorders Network website  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Susan Meikle, MD MSPH, Sponsor Investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00597935     History of Changes
Other Study ID Numbers: 16P01, 2U01HD041249, 2U10HD041250, 2U10HD041261, 2U10HD041267, 1U10HD054136, 1U10HD054214, 1U10HD054215, 1U10HD054241
Study First Received: January 9, 2008
Last Updated: May 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
prolapse
urinary incontinence
uterosacral vaginal vault ligament suspension
 sacrospinous ligament fixation
behavioral therapy
pelvic muscle training

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013