Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: Design and methods

Matthew D. Barber, Linda Brubaker, Shawn Menefee, Peggy Norton, Diane Borello-France, Edward Varner, Joseph Schaffer, Alison Weidner, Xiao Xu, Cathie Spino, Anne Weber

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. A centralized biostatistical coordinating center will oversee data collection and analysis. Two approaches will be investigated simultaneously using a 2 × 2 randomized factorial design: a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (behavioral and pelvic floor muscle training versus usual care). Surgeons have standardized essential components of each surgical procedure and have met specific standards of expertise. Providers of the behavioral intervention have undergone standardized training. Anatomic, functional, and health-related quality of life outcomes will be assessed using validated measures by researchers blinded to all randomization assignments. Cost-effectiveness analysis will be performed using prospectively collected data on health care costs and resource utilization. The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.

Original languageEnglish (US)
Pages (from-to)178-189
Number of pages12
JournalContemporary Clinical Trials
Volume30
Issue number2
DOIs
StatePublished - Mar 2009

Fingerprint

Pelvic Floor Disorders
Uterine Prolapse
Pelvic Floor
Ligaments
Muscles
Suspensions
National Institute of Child Health and Human Development (U.S.)
Research Personnel
Pelvic Organ Prolapse
Recurrence
Retreatment
Stress Urinary Incontinence
Health Resources
Prolapse
Random Allocation
Health Care Costs
Cost-Benefit Analysis
Quality of Life

Keywords

  • Behavioral therapy
  • Factorial design
  • Pelvic floor muscle training
  • Pelvic organ prolapse
  • Randomized surgical trial
  • Sacrospinous ligament fixation
  • Stress urinary incontinence
  • Uterine prolapse
  • Uterosacral ligament suspension
  • Vaginal prolapse

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

Cite this

Barber, M. D., Brubaker, L., Menefee, S., Norton, P., Borello-France, D., Varner, E., ... Weber, A. (2009). Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: Design and methods. Contemporary Clinical Trials, 30(2), 178-189. https://doi.org/10.1016/j.cct.2008.12.001

Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial : Design and methods. / Barber, Matthew D.; Brubaker, Linda; Menefee, Shawn; Norton, Peggy; Borello-France, Diane; Varner, Edward; Schaffer, Joseph; Weidner, Alison; Xu, Xiao; Spino, Cathie; Weber, Anne.

In: Contemporary Clinical Trials, Vol. 30, No. 2, 03.2009, p. 178-189.

Research output: Contribution to journalArticle

Barber, MD, Brubaker, L, Menefee, S, Norton, P, Borello-France, D, Varner, E, Schaffer, J, Weidner, A, Xu, X, Spino, C & Weber, A 2009, 'Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: Design and methods', Contemporary Clinical Trials, vol. 30, no. 2, pp. 178-189. https://doi.org/10.1016/j.cct.2008.12.001
Barber, Matthew D. ; Brubaker, Linda ; Menefee, Shawn ; Norton, Peggy ; Borello-France, Diane ; Varner, Edward ; Schaffer, Joseph ; Weidner, Alison ; Xu, Xiao ; Spino, Cathie ; Weber, Anne. / Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial : Design and methods. In: Contemporary Clinical Trials. 2009 ; Vol. 30, No. 2. pp. 178-189.
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