JU INSIGHT Prophylactic Use of Biologic Mesh in Ileal Conduit (PUBMIC): A Randomized Clinical Trial

By: Hooman Djaladat, MD, MS, Keck School of Medicine, University of Southern California, Los Angeles; Alireza Ghoreifi, MD, Keck School of Medicine, University of Southern California, Los Angeles; Tapas Tejura, MD, Keck School of Medicine, University of Southern California, Los Angeles; Gus Miranda, BS, Keck School of Medicine, University of Southern California, Los Angeles; Jie Cai, MS, Keck School of Medicine, University of Southern California, Los Angeles; Farshad Sheybaee Moghaddam, MD, Keck School of Medicine, University of Southern California, Los Angeles; Ileana Aldana, MPH, Keck School of Medicine, University of Southern California, Los Angeles; Rene Sotelo, MD, Keck School of Medicine, University of Southern California, Los Angeles; Inderbir Gill, MD, Keck School of Medicine, University of Southern California, Los Angeles; Sumeet Bhanvadia, MD, Keck School of Medicine, University of Southern California, Los Angeles; Anne Schuckman, MD, Keck School of Medicine, University of Southern California, Los Angeles; Mihir Desai, MD, Keck School of Medicine, University of Southern California, Los Angeles; Monish Aron, MD, Keck School of Medicine, University of Southern California, Los Angeles; Siamak Daneshmand, MD, Keck School of Medicine, University of Southern California, Los Angeles; Vinay Duddalwar, MD, FRCR, Keck School of Medicine, University of Southern California, Los Angeles | Posted on: 18 Jun 2024

Djaladat H, Ghoreifi A, Tejura T, et al. Prophylactic use of biologic mesh in ileal conduit (PUBMIC): a randomized clinical trial. J Urol. 2024;211(6):743-753. doi:10.1097/JU.0000000000003902

Study Need and Importance

Parastomal hernia (PSH) commonly occurs following ileal conduit (IC) urinary diversion, which may cause pain, appliance dysfunction, and, rarely, strangulation and obstruction. Various strategies proposed to prevent PSH, including the use of prophylactic mesh, have shown inconsistent outcomes. A trial involving patients undergoing radical cystectomy and IC indicated no significant change in the radiological PSH rate but did show a decreased occurrence of clinical hernias. The current randomized clinical trial aimed to evaluate the impact of prophylactic biologic mesh on PSH development in patients undergoing cystectomy and IC.

What We Found

A total of 146 patients were enrolled and randomized into mesh (n = 72) and control (n = 74) arms (Figure). Median operative time was 31 minutes longer in patients who received mesh, but this difference was not statistically significant. With a median follow-up of 24 months, radiological and clinical PSHs were detected in 37 (18 mesh recipients vs 19 controls) and 16 (8 in both arms) patients, respectively. No definite mesh-related adverse events were reported. Five patients (3 in the mesh and 2 in the control arm) required surgical PSH repair. Radiological PSH-free survival rates in the mesh and control groups were 74% vs 75% at 1 year and 69% vs 62% at 2 years. On multivariable analysis, prior abdominopelvic radiation (HR 3.4) and pathological T stage > 2 (HR 2.1) were independently associated with an increased risk of PSH.

Figure. Workflow of the study. DM indicates diabetes mellitus; IC, ileal conduit; PSH, parastomal hernia; USC, University of Southern California.

Limitations

The main limitation of our study was the intermediate follow-up length. In addition, the incidence of clinical PSH might have been underestimated. Finally, our study lacks a cost-benefit analysis.

Interpretation for Patient Care

Biologic mesh does not have a protective effect on PSH development within 2 years following cystectomy and IC. Nevertheless, the use of prophylactic biologic mesh is deemed safe, with no mesh-related complications in intermediate-term follow-up.