The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study

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.

Inclusion Criteria:

1. Completion of the Year 2 OPTIMAL in-person visit

Exclusion Criteria:

1. Inability to provide informed consent.

2. Subjects who are long-term residents of a skilled nursing facility (that is, residency
is not limited to short-term rehabilitation) at the time of enrollment into E-OPTIMAL.
Note: Subjects unable to return for annual visits are not excluded as they can
participate in the telephone interview. However, every attempt will be made to
encourage in-person participation.

Criteria for termination of participation:

(Due to evidence or likelihood that the subject can no longer consent for herself)

1. Subjects 75 years and older that fail the telephone mini-mental status examination. If
the participant gets 5 or more of the 10 items "incorrect" the interviewer says "thank
you very much for your time, that completes the interview for today." In other words,
the interviewer in no way implies to the participant that they did not "pass" a test
to continue. The interviewer contacts the appropriate site coordinator immediately
after the interview to let them know of the outcome.

2. Subjects younger than 75 who appear to have cognitive deficits during the quality of
life telephone interview will be administered the mini-mental status examination;
those who fail will be excluded from further participation. (Proxy respondents will
not be used.) Subjects who appear to have cognitive deficits during the in-person
visit or site telephone interview will be withdrawn from the study by the study
coordinator.

3. Subjects who become long-term residents of a skilled nursing facility.

4. Withdrawal of consent. Verbal assent will be obtained prior to each telephone
interview and each in-person visit.

Note: Subjects that are unable to complete telephone interviews (for example, because of
hearing loss) may complete the interview portion of the survey in person, either at the
site or in the home.