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

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ClinicalTrials.gov Identifier: NCT00597935
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : September 30, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: SSLF Procedure: ULS Behavioral: PMT Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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
Study Start Date : February 2008
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Procedure: SSLF
sacrospinous ligament fixation (SSLF)
Behavioral: PMT
Pelvic muscle training and exercises (PMT)
Experimental: 2
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)

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. For Pelvic Muscle Therapy: urinary symptoms as measured by the UDI of the PFDI [ Time Frame: 6 mo ]
  3. For Pelvic Muscle Therapy: prolapse symptoms as measured by the POPDI subscale of the PFDI and anatomic outcomes [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 6 and 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597935

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
NICHD Pelvic Floor Disorders Network
Office of Research on Women's Health (ORWH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Matthew Barber, MD The Cleveland Clinic
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dwallace, Project Director, RTI International
ClinicalTrials.gov Identifier: NCT00597935     History of Changes
Other Study ID Numbers: 16P01
2U01HD041249 ( U.S. NIH Grant/Contract )
2U10HD041250 ( U.S. NIH Grant/Contract )
2U10HD041261 ( U.S. NIH Grant/Contract )
2U10HD041267 ( U.S. NIH Grant/Contract )
1U10HD054136 ( U.S. NIH Grant/Contract )
1U10HD054214 ( U.S. NIH Grant/Contract )
1U10HD054215 ( U.S. NIH Grant/Contract )
1U10HD054241 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: September 2013

Keywords provided by dwallace, RTI International:
urinary incontinence
uterosacral vaginal vault ligament suspension
sacrospinous ligament fixation
behavioral therapy
pelvic muscle training

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