BPH surgery complications underestimated in trials

Paris-Practice complication rates following surgical treatment for BPH are higher than indicated by clinical trials, according to a recent study.

Investigators conducted a prospective analysis of a French national patient registry, reviewing 262,898 patients who underwent surgery for BPH, to assess the actual complication rate following surgical management of bladder outlet obstruction (BOO)/BPH.

Dr. Cornu and colleagues reviewed the database from 2004 to 2007 for patients who underwent surgery for BPH, including TURP and open prostatectomy (OP). The authors also assessed all subsequent surgical procedures related to complications (clot retention removal, urinary incontinence, stricture surgery) or re-interventions for BPH.

More re-intervention in TURP patients

The total number of procedures during the study period was 262,989, of which the vast majority was TURP (about 1:10). Re-intervention for BOO persistence and/or recurrence was performed in 4.77% of cases of TURP and 1.92% of OP cases, Dr. Cornu reported in his presentation at the European Association of Urology annual congress in Paris. Median follow-up was approximately 2 years.

Surgery for clot retention following TURP was performed in 3.4% of cases and following OP in 3.7% of cases. Surgery for incontinence was done following TURP in 1.8 cases per thousand and following OP in 0.9 cases per thousand. Surgery for urethral stenosis following TURP was performed in 2.7% of cases and following OP in 1.3% of cases.

Dr. Cornu explained that the French database connects nationally, showing all prostatic surgeries and all subsequent surgeries undergone by patients. The database is centralized due to the socialized medical system in France, which is necessary for reimbursement purposes. All subsequent surgeries, hospital stays, and medications are also registered.

"One of the problems with database analyses is the coding," noted session attendee Claus G. Roehrborn, MD, professor and chair of urology at the University of Texas Southwestern Medical Center in Dallas. "With your 5% reoperation rate, it is unclear whether it was for a bladder neck contracture or a re-growth of tissue. How do you handle that in the first category; how detailed are you with those specifics?"

"Although not detailed here, we have a code for each intervention, main diagnosis [re-operation], and associated diagnosis [such as a stricture]," Dr. Cornu said. "We would, however, be subject to new biases in coding the main diagnosis. Being too specific can have major drawbacks, as well. At present, this is the only such data and analysis we have, and it has revealed some interesting outcomes."

Session co-chair Kenneth M. Anson, MD, of St. George's Hospital, London, noted that the outcome of the database analysis seemed to support the belief that the retreatment rate after TURP is not insignificant.

"Yes, it does," Dr. Cornu replied. "The data is only descriptive, but it can be potentially useful for objective patient counseling and for monitoring clinical practice, with evolution of surgical techniques and new guidelines. The analysis included every patient, even complicated cases that might be excluded from usual clinical trials. No laser procedures are individualized here, however, as the code did not exist in France before 2007, but the use of laser therapies in France before this date was very limited. A new code for laser has been set, allowing us to monitor the evolution of new technologies."