Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial
NCT ID: NCT00597935
Last Updated: 2020-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
374 participants
INTERVENTIONAL
2008-02-29
2013-07-31
Brief Summary
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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.
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Detailed Description
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Women who are planning surgery for apical vaginal prolapse often experience bladder and bowel symptoms, as well as pressure and a bulge. These symptoms might include urinary leakage (urinary incontinence), urinary urgency (a sudden strong desire to urinate with fear that leakage may occur) or frequent urination, difficulty starting to urinate or perhaps a slow weak urinary stream, as well as accidental bowel leakage (fecal incontinence). After surgery, bladder and bowel symptoms may get better, get worse, or stay the same as before surgery. Sometimes new symptoms can start after surgery even if they weren't present before surgery.
The OPTIMAL study was designed to compare two commonly performed vaginal surgeries for pelvic organ prolapse. One is the sacrospinous ligament fixation, called SSLF for short. The other is the uterosacral ligament suspension, called ULS. Both surgeries involve attaching the top of the vagina, which has fallen down, to internal ligaments in the pelvis in order to resuspend the vagina and correct the prolapse.
The investigators were also interested in studying how the surgeries altered bladder and bowel symptoms. They had seen in other studies that behavioral and pelvic floor muscle therapy (PMT) is an effective therapy for stress and urge urinary incontinence, fecal incontinence, and other pelvic floor disorders. It is relatively easy to perform, and has rare side effects. They wondered if PMT around the time of surgery might further improve these symptoms.
The OPTIMAL study has two main purposes:
1. To find out which type of surgery, SSLF or ULS, has better results when used to repair prolapse of the top of the vagina,
2. To find out whether or not doing pelvic muscle exercises and behavioral changes around the time of surgery will affect both bladder and bowel symptoms after surgery, and the success of the prolapse repair.
Four Hundred women were enrolled into the OPTIMAL study, from January 2008 to May 2011. These women were randomly assigned to receive either the SSLF or the ULS surgery. They were randomly assigned to either receive the PMT training with a therapist before and after surgery or to not receive this therapy. So women fell into one of four groups:
1. SSLF plus PMT
2. ULS plus PMT
3. SSLF without PMT
4. ULS without PMT
Women in this study were followed closely at regular intervals for two years after surgery.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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SSLF and PMT
Sacrospinous Ligament Fixation (SSLF) and Pelvic Muscle Training \& Exercises (PMT)
SSLF
sacrospinous ligament fixation (SSLF)
PMT
Pelvic muscle training and exercises (PMT)
ULS and PMT
Uterosacral Vaginal Vault Ligament Suspension (ULS) and Pelvic Muscle Training \& Exercises (PMT)
ULS
uterosacral vaginal vault ligament suspension (ULS)
PMT
Pelvic muscle training and exercises (PMT)
SSLF without PMT
Sacrospinous Ligament Fixation (SSLF) without Pelvic Muscle Training \& Exercises (PMT)
SSLF
sacrospinous ligament fixation (SSLF)
ULS without PMT
Uterosacral Vaginal Vault Ligament Suspension (ULS) without Pelvic Muscle Training \& Exercises (PMT)
ULS
uterosacral vaginal vault ligament suspension (ULS)
Interventions
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SSLF
sacrospinous ligament fixation (SSLF)
ULS
uterosacral vaginal vault ligament suspension (ULS)
PMT
Pelvic muscle training and exercises (PMT)
Eligibility Criteria
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Inclusion Criteria
* Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C \> -TVL/2) \[TVL stands for total vaginal length\]
* Vaginal bulge symptoms as indicated by an affirmative response to either questions on the Pelvic Floor Distress Inventory (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 tension free vaginal tape (TVT) is planned to treat stress urinary incontinence.
* A pelvic muscle training (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
* 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. \[Both ULS and SLS include removal of the uterus, if not previously removed\]
18 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Pelvic Floor Disorders Network
NETWORK
Responsible Party
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Principal Investigators
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Matthew Barber, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Kaiser Permanente Bellflower
Bellflower, California, United States
University of California, San Diego Medical Center
La Jolla, California, United States
Kaiser Permanente
San Diego, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Barber MD, Brubaker L, Menefee S, Norton P, Borello-France D, Varner E, Schaffer J, Weidner A, Xu X, Spino C, Weber A; Pelvic Floor Disorders Network. Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods. Contemp Clin Trials. 2009 Mar;30(2):178-89. doi: 10.1016/j.cct.2008.12.001. Epub 2008 Dec 16.
Borello-France D, Newman DK, Markland AD, Propst K, Jelovsek JE, Cichowski S, Gantz MG, Balgobin S, Jakus-Waldman S, Korbly N, Mazloomdoost D, Burgio KL; NICHD Pelvic Floor Disorders Network. Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse. Phys Ther. 2023 Sep 1;103(9):pzad059. doi: 10.1093/ptj/pzad059.
Jakus-Waldman S, Brubaker L, Jelovsek JE, Schaffer JI, Ellington DR, Mazloomdoost D, Whitworth R, Gantz MG; NICHD Pelvic Floor Disorders Network (PFDN). Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair. Obstet Gynecol. 2020 Nov;136(5):933-941. doi: 10.1097/AOG.0000000000004092.
Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.
Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23.
Lukacz ES, Warren LK, Richter HE, Brubaker L, Barber MD, Norton P, Weidner AC, Nguyen JN, Gantz MG. Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse. Obstet Gynecol. 2016 Jun;127(6):1071-1079. doi: 10.1097/AOG.0000000000001442.
Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719.
Barber MD, Kenton K, Janz NK, Hsu Y, Dyer KY, Greer WJ, White A, Meikle S, Ye W. Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):205-10. doi: 10.1097/SPV.0b013e31825e6422.
Barber MD, Janz N, Kenton K, Hsu Y, Greer WJ, Dyer K, White A, Meikle S, Ye W. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. doi: 10.1097/SPV.0b013e31825d65aa.
Other Identifiers
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16P01
Identifier Type: -
Identifier Source: org_study_id
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