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

• 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 ]

• For the surgical intervention: surgical "success" or "failure" 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 ]

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.

• Procedure: SSLF
  sacrospinous ligament fixation (SSLF)
• Procedure: ULS
  uterosacral vaginal vault ligament suspension (ULS)
• Behavioral: PMT
  Pelvic muscle training and exercises (PMT)

• Experimental: 1
  SSLF and PMT
  Interventions:

  • Procedure: SSLF
  • Behavioral: PMT
• Experimental: 2
  ULS and PMT
  Interventions:

  • Procedure: ULS
  • Behavioral: PMT
• Experimental: 3
  SSLF without PMT
  Intervention: Procedure: SSLF
• Experimental: 4
  ULS without PMT
  Intervention: Procedure: ULS

• 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. Epub 2008 Dec 16.
• 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.
• 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.

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]