'Practice Changing' Trial on Activity Recs After Prolapse Surgery

Telling patients who undergo pelvic organ prolapse (POP) surgery they can resume physical activity and work as soon as they're able to resulted in noninferior anatomic and symptomatic outcomes compared with standard recommendations, a randomized trial showed.

Of 107 women who underwent minimally invasive surgery at a single center, maximum anatomic POP support loss and Pelvic Organ Prolapse Distress Inventory (POPDI) symptom scores at 3 months were no different between the expedited activity group and the standard group, where patients are instructed to limit their physical activity for a period of 6 weeks, reported Matthew Barber, MD, MHS, of Duke University School of Medicine in Durham, North Carolina, and co-authors in JAMA Surgery.

"This study is a paradigm shift for urogynecologists -- it is practice changing," Barber said in a press release. "For decades, surgeons have been instructing patients to avoid activity after reconstructive surgery, and we now know that is unnecessary."

"The findings of this study are consistent with trials in other fields, like orthopedics and hernia surgery, which have shown that early activity doesn't impede outcomes and may improve them in some circumstances," he added.

Despite a lack of evidence, a majority of gynecologic surgeons recommend lifting and activity restrictions after POP surgery to avoid intra-abdominal pressure that could compromise reconstruction. However, the study's results suggest that surgeons have been overly cautious.

At 3 months, mean maximum anatomic POP support loss (SLmax) was -1.7 cm in the expedited group versus -1.5 cm in the standard group (P=0.44). And the co-primary outcome of POPDI symptom score was a mean 23.7 points in the expedited group compared with 25.7 points in the standard group (P=0.80).

The mean maximum support loss was 0.18 cm higher within the vaginal canal in the expedited group after adjusting for baseline SLmax (95% CI -0.68 to 0.33 cm), while the mean POPDI scores were 5.79 points lower in the expedited group after adjustment for baseline scores (95% CI -20.41 to 8.84).

In addition, median return-to-work time was 28 days in the expedited group and 34 days in the standard activity group (P=0.58).

"Thus, while taking into account individual patient characteristics, it is reasonable to instruct patients undergoing minimally invasive prolapse surgery to resume physical activities ad lib, while reassuring patients that expedited resumption of physical activities will not result in worse outcomes," Barber and team concluded.

In an invited commentary, Marisa Vega, MD, and Cecile Ferrando, MD, MPH, both of the Cleveland Clinic, noted that "the potential for macroeconomic outcomes is barely implied" in the study. To explore these implications, they looked at their own urogynecologic practice.

"Based on our current return-to-work recommendations, if we assume 41% working patients as per the ... study, this number of cases equates to 3,028 weeks off from work," they wrote. "If we were to implement liberalized activity recommendations and patients returned to work approximately 28 days after surgery, 1,010 working weeks would be added back into the workforce from our institution alone."

"We can now reassure patients that they can safely return to work as soon as they feel ready without increasing complications, compromising surgical outcomes, or decreasing satisfaction rates," Vega and Ferrando concluded. "More liberal activity recommendations could relieve individual patient stress with regard to job insecurity and income loss while mutually having a positive economic effect on our struggling workforce."

For this noninferiority trial, the researchers included patients undergoing vaginal or laparoscopic apical reconstructive surgery for POP at a single academic tertiary referral center in Durham from July 2020 through October 2021. Patients were excluded if they were enrolled in another POP research study, had concomitant non-urogynecologic surgery, had another surgery planned within 3 months of the POP surgery, or if other treatments might result in prolonged inactivity, among other reasons.

A total of 123 participants (mean age 62.8 years) were randomized in a 1:1 ratio to standard or expedited activity restrictions, and 107 had complete 3-month outcome data available. The standard group was instructed not to lift anything over 10 lb for 6 weeks, and to return to work after 6 weeks for jobs involving manual labor or after 2 weeks for sedentary jobs. The expedited group was simply told to resume activities and work as soon as they felt able to. Both groups were instructed to avoid sexual activity for a period of 6 weeks.

Preoperative physical function was measured by a 2-minute step test and chair stand test. Participants wore an ActiGraph wGT3X-BT accelerometer for 4 days before surgery and for 6 weeks after.

About 45% of patients undergoing a laparoscopic approach received robotic-assisted laparoscopic sacrocolpopexy with mesh, and 53.2% underwent a vaginal approach, which included native tissue or graft-augmented repairs.

There were no significant differences in accelerometer-based recovery time, and both groups recovered to 90% of their baseline activity.

There were also no significant differences between groups for secondary outcomes, including patient-reported measures of pelvic floor symptoms, as well as condition-specific and more general health-related quality-of-life measures.

Barber and team noted that the 3-month study period was chosen because "any biologically plausible consequence of increased physical activity would likely manifest by 3 months after surgery," although a longer study period would give more time for surgical failures to appear. They are currently conducting a 2-year follow-up study on symptomatic outcomes.

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