Standard Restrictions vs Expedited Activity After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial.

IMPORTANCE

Restrictions on postoperative activity following pelvic organ prolapse (POP) surgery are not evidence based. Nonetheless, many pelvic surgeons place lifting and activity restrictions on patients following surgery.

OBJECTIVE

To evaluate whether expedited activity results in noninferior anatomic and symptomatic outcomes compared with standard activity restrictions after POP surgery.

DESIGN, SETTING, AND

PARTICIPANTS

This randomized noninferiority clinical trial included patients undergoing vaginal or laparoscopic apical reconstructive surgery for POP between July 1, 2020, and October 31, 2021, at a single academic tertiary referral center in Durham, North Carolina. Anatomic outcomes were assessed by masked examiners, and subjective outcomes were assessed via validated surveys, both completed at 3 months postoperatively. Patients meeting minimum physical activity criteria with at least stage II bothersome POP were eligible. A total of 218 patients were approached, of whom 123 were randomly assigned and 107 had complete outcome data and were included in the analysis.

INTERVENTIONS: Patients were randomly assigned to receive standard restrictions vs expedited postoperative activity instructions.

MAIN OUTCOMES AND MEASURES: The anatomic coprimary outcome was maximum anatomic POP support loss (SLmax), which is the most distal point of pelvic organ support loss according to the Pelvic Organ Prolapse Quantification System (noninferiority margin, 1.0 cm). The symptomatic coprimary outcome was the Pelvic Organ Prolapse Distress Inventory (POPDI) symptom score (noninferiority margin, 34.3 points). Differences between outcomes were assessed using linear regression models controlling for baseline SLmax and POPDI, respectively.

RESULTS

Of 123 participants randomized, 107 had complete 3-month outcome data and were included in the analysis. Mean (SD) age was 62.8 (10.1) years. At 3 months, mean (SD) SLmax was -1.7 (1.4) cm in the expedited group and -1.5 (1.4) cm in the standard group (P = .44). After adjusting for baseline SLmax, the mean maximum support loss was 0.18 cm higher within the vaginal canal in the expedited group (95% CI, -0.68 to 0.33 cm). The coprimary outcome of POPDI score was a mean (SD) 23.7 (41.8) points in the expedited group vs 25.7 (39.3) points in the standard group (P = .80). After adjusting for baseline scores, mean POPDI scores were 5.79 points lower in the expedited group (95% CI, -20.41 to 8.84).

CONCLUSIONS AND RELEVANCE: The findings demonstrate that expedited activity after prolapse surgery results in noninferior anatomic and symptomatic prolapse outcomes. It is reasonable to instruct patients undergoing minimally invasive prolapse surgery to resume physical activities ad lib postoperatively.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04329715.