The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study (E-OPTIMAL)

• Time to surgical failure [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
  The primary outcome for the surgical intervention of OPTIMAL is time to surgical failure using the definition of surgical failure as used in OPTIMAL, i.e., anatomic assessment of prolapse using the Pelvic Organ Prolapse Quantitative(POPQ) system and the presence of bulge symptoms specific to prolapse, using Pelvic Floor Distress Inventory (PFDI) questions 4 & 5
  
  
• Enrollment primary outcome measure [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
  The primary outcome for E-OPTIMAL primary aim 4, the enrollment intervention, will be the proportion of eligible subjects who consent to enroll in E-OPTIMAL, and complete all 3 data collection events in year 3 of E-OPTIMAL follow-up (year 5 from enrollment in OPTIMAL).
  
  
• Development of prolapse symptoms [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
  The primary outcome of the PMT intervention will be the development of prolapse symptoms as measured by the pelvic organ prolapse distress inventory (POPDI) subscale of the Pelvic floor distress inventory (PFDI) and anatomic outcomes assessed up to 5 years after surgery. The primary anatomic outcome is identically defined to the primary anatomic outcome described for the surgical intervention and assessed as time to failure.
  
  

• Efficacy measures (secondary measures for surgical intervention) [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
  1. Anatomic outcomes of each vaginal segment
  2. Time to anatomic prolapse recurrence
  3. Time to symptomatic prolapse recurrence
  4. Pelvic symptoms: change from baseline in Urogenital Distress Inventory (UDI), Colorectal-anal Distress Inventory (CRADI), Pelvic Organ Prolapse Distress Inventory (POPDI) & Hunskaar Incontinence Severity Index
  5. Re-operation rates for complications, prolapse, stress urinary incontinence;
  6. Non-surgical treatment for pelvic floor disorders;
  7. QOL: Short Form 36 (SF-36) & Pelvic floor impact questionnaire (PFIQ)
  
  
• Safety measures (secondary measures for surgical intervention) [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: Yes ]

  Long-term adverse events specific to the surgical procedure:

  1. Vaginal granulation tissue, suture erosion or mesh exposure /erosion requiring treatment
  2. Vaginal or perineal stricture (i.e., narrowing or scarring) prompting a treating physician to suggest, or the subject to request, treatment (surgical or non-surgical)
  
  
• Enrollment measures [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
  1. The proportion of patients who enroll in E-OPTIMAL
  2. The proportion who complete follow-up at 3, 4 and 5 years after surgery
  3. Total number of data collection events (clinic visits, site and QOL calls), number of in-person clinic visits, and number of QOL calls completed
  4. Satisfaction with the study informed consent process
  5. Study-level and personal-level motivation and barriers to enrollment in E-OPTIMAL
  
  
• PMT intervention measures [ Time Frame: up to 5 years post surgery ] [ Designated as safety issue: No ]
  1. The anatomic outcomes of each vaginal segment
  2. Hunskaar Incontinence Severity Index
  3. change from baseline in Urogenital Distress Inventory (UDI) and Colorectal-anal Distress Inventory (CRADI) subscales
  4. Patient Global Impression of Improvement (PGI-I)
  5. Reoperation for stress urinary incontinence
  6. Postoperative treatment for overactive bladder symptoms
  7. QOL: Short Form 36 (SF-36) & Pelvic floor impact questionnaire (PFIQ)
  8. Brink's scale
  
  

The goal of this long-term follow-up study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study is a randomized trial designed to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS) and 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 (SUI).

The OPTIMAL study includes a two-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. A further goal of E-OPTIMAL is to investigate a strategy for improving enrollment and retention in long-term studies of women undergoing surgery for pelvic organ prolapse and SUI, by randomizing subjects to two different recruitment methods.

The primary aims of this extension study are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and stress urinary incontinence:

1. time to surgical failure;
2. the long-term functional and health-related quality of life (QOL), adjusted for PMT treatment group;
3. the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms (urinary, bowel, and prolapse), adjusted for PMT treatment group.

An additional primary aim (aim 4) is to determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention in E-OPTIMAL. We will utilize a conceptual framework that assesses three concepts (motivation, barriers and pragmatic issues) at two levels (study level and personal/individual level). This conceptual framework was developed following a review of the scant available literature on the topic, as well as during discussions with investigators who are experienced in recruiting and retaining participants in pelvic floor disorders studies.