Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse
Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse
The objective of the EVeRLAST study is to determine whether expedited resumption of
 postoperative activity levels is non-inferior to standard activity restrictions with respect
 to short-term anatomic prolapse outcomes. We hypothesize that immediate resumption of
 physical activities as tolerated will result in noninferior surgical outcomes following
 prolapse surgery when compared to standard postoperative activity restrictions.

 Participants will be enrolled and randomized at their preoperative clinic visit to one of two
 treatment arms:

 Arm 1: Standard instructions (no heavy lifting over 10lbs for 6 weeks; return to work at 4
 weeks for sedentary work and 6 weeks for manual labor) Arm 2: Liberal instructions (no
 restrictions; resume activities and work as soon as able)

 We will also collect subjective and objective measures of pre- and postoperative physical
 activity, through the use of patient-reported physical activity assessments and wrist-worn
 accelerometers. Accelerometer data will be collected at the preoperative,
 2-week-postoperative, and 6-week-postoperative time points. Accelerometer data will also be
 used to calculate time to resumption of normal activities, defined as time at which a patient
 resumes greater than 90% of her baseline preoperative level of physical activity. We will
 additionally be collecting data on relevant patient-reported outcomes of pelvic floor symptom
 severity, health-related quality of life measures, postoperative pain, time to return to work
 (where relevant), and patient global impression of improvement. Postoperative anatomic
 assessments will be performed at 6 weeks and 3 months postoperatively by blinded study
 personnel
Specific aim 1: Determine if liberal (ad lib) resumption of postoperative activity levels is
 non-inferior to standard restrictions with regards to short-term anatomic and symptomatic
 outcome, as measured by maximum pelvic organ prolapse support loss ('SLmax') and the Pelvic
 Organ Prolapse Distress Inventory (POPDI) at 3 months. (Co-primary outcome)

 Specific aim 2: Compare postoperative "Recovery Time" and physical function between women
 instructed to resume their activity levels ad lib versus women instructed to restrict
 activity levels. "Recovery Time," defined as the postoperative day at which the patient
 resumes 90% of her baseline activity levels will be objectively measured using the Actigraph
 accelerometer.8 ,9 Physical function will be measured with the 6-minute walk, chair stand
 tests, and through patient-reported outcome measures. (exploratory outcome)

 Specific aim 3: Compare timing of return-to-work and health-related QOL in women instructed
 to resume activity levels and return to work ad lib versus restrict their activity levels
 (exploratory outcome)

 Eligible participants will first be briefly explained regarding the research study. If
 interested, will then complete the informed consent process. She will first be asked to
 complete the International Physical Activity Short Form to confirm study eligibility. For
 study eligibility, participants must at least report a baseline of 725 MET-minutes per week
 of physical activity according to the IPAQ-SF, which is consistent with the lowest quartile
 of activity among elderly women. If she reports greater than 725 MET-minutes per week of
 physical activity, she will undergo the remainder of baseline assessments. If she reports
 less than 725 MET-minutes per week of physical activity, she will be explained that she does
 not meet the activity level criteria for completion of the study at this time. She will then
 be asked to complete a series of baseline questionnaires (demographics, past medical history,
 POPDI, AAS, PROMIS, PFDI, PFIQ). She will also undergo a baseline POPQ exam and tests of
 physical function, including the 6-minute walk test and chair stand test.

 A sealed envelope will then be opened by the research coordinator (or study investigator) in
 front of the patient indicating the patient's study allocation. The packet will also include
 an accelerometer which the patient will be instructed to wear for a 7-day period
 preoperatively. However, to ensure that participants are not given an accelerometer too far
 in advance from her surgery (as at times surgery may be scheduled remotely from the initial
 decision to proceed with surgery which would potentially result in too many accelerometers
 being out of circulation), the envelope containing study allocation and accelerometers may
 alternatively be provided at the preoperative "Surgical Workup" visit once the surgery is
 scheduled and at a date no greater than 3 weeks from the planned surgery. If a participant
 will be undergoing surgery at an interval greater than 1 week from the initial receipt of the
 accelerometer, she will only be required to wear the accelerometer for 1 week prior to the
 surgery. Patients will be given an opportunity to ask any questions regarding postoperative
 activity instructions to research personnel or nurses at the time of study enrollment and at
 any point prior to her surgery. Patients will be notified, prior to providing consent, that
 her primary surgeon will remain blinded as to her treatment allocation until completion of
 her study participation.

 Any questions related to surgical recovery which arise preoperatively will be addressed by
 nurses and research personnel not involved in the patient's intraoperative decision-making.
 Postoperatively, fellow and attending surgeons will only be unblinded if necessary to address
 any acute postoperative issues. Patients will also be provided with a duplicate set of
 postoperative set of activity instructions on the day of her surgery upon discharge which
 will be entered in the patient's electronic chart by study personnel on the day of her
 surgery as a modification to the standard postoperative discharge instructions.

 The patient will wear the activity tracker for 6 weeks postoperatively. At the 1-week
 postoperative time point, patient reminder phone calls will be made to remind the patient to
 wear and charge the activity tracker (whose battery life is 25 days). She will also be asked
 to provide a count of the number of narcotic pills she has left remaining at this time. She
 will follow-up for a routine postoperative visit with her primary surgeon at which point a
 routine 6-week postoperative POPQ will be performed. Accelerometers will be returned at this
 visit.

 She will then follow up for a separate research visit at 3 months postoperatively. At this
 time, the patient will complete all follow-up activity, symptom, and HRQOL questionnaires
 including the: Activities Assessment Scale, Pelvic Floor Distress Inventory, Pelvic Floor
 Impact Questionnaire, and the PROMIS short form subscales of physical function, anxiety,
 depression, fatigue, satisfaction with social role, and pain interference. A six-minute walk
 and chair stand test will be administered by trained research personnel in the clinic. She
 will additionally be inquired regarding timing of return to work. A POPQ will also be
 performed at this time by a blinded provider NOT involved in the patient's index surgery.
Inclusion Criteria:

 -  Stage II-IV pelvic organ prolapse

 -  Bothersome bulge symptoms

 -  At least 725 MET-minutes/week on International Physical Activity Questionnaire Short
 Form

 -  English-speaking

 -  Undergoing treatment of prolapse

 -  Surgery occurring at least 7 days from date of randomization (to allow for collection
 of at least 7 days of preoperative accelerometer data)

 -  Able and willing to follow up at 3 months for in-office exam

 Exclusion Criteria:

 -  Enrollment in another research study of pelvic organ prolapse

 -  Concomitant non-urogynecologic surgery

 -  Planned further surgery in the next 3 months or anticipated treatment which would
 result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively