Objectives: There is no standard of care for women sustaining an obstetric anal sphincter injury (OASIS). We sought to determine whether pelvic floor physical therapy (PFPT) would improve the quality of life and function in women 12 weeks after OASIS.
Methods: This institutional review board-approved randomized trial enrolled primiparous women 2 weeks after delivery complicated by OASIS. After informed consent, all subjects underwent vaginal electromyography and anorectal manometry and completed validated questionnaires; measures were repeated for all subjects at 12 weeks after delivery. The intervention arm completed 4 PFPT sessions. The primary outcome was a change in the Fecal Incontinence Quality of Life.
Results: Three hundred four women were screened; 250 were excluded, and 54 were randomized. After four were lost to follow-up, analysis included 27 in the intervention arm and 23 in the control arm. Overall, mean age was 29.8 ± 4.7 years, and there were no demographic differences between groups.Fecal Incontinence Quality of Life domain scores showed improvement for both groups from baseline to 12 weeks for coping (P = 0.006) and depression (P = 0.009); however, there was no difference in domain scores between groups. For the secondary outcome of anorectal manometry, squeezing pressure improved for all subjects (P = 0.035) from baseline to 12 weeks. Vaginal EMG strength (microvolts) increased for all subjects in measures of rest average (P < 0.000), rapid peak (P = 0.006), and work average (P < 0.000), with no difference based on therapeutic arm.
Conclusions: All women showed improvements in quality of life and function at 12 weeks after delivery, regardless of treatment allocation. Further study is needed to determine whether PFPT provides a significant benefit to women having OASIS.
Trial registration: ClinicalTrials.gov NCT01672697.