ObjectivesAnalysing the results of implanting periurethral balloons (Pro-ACT®) to treat male urinary incontinence due to sphincteral insufficiency (UI/SI) under a retrospective monocentric study covering 60 consecutive patients treated between 2006 and 2009.Patients and methodsWe retrospectively studied the files of 60 patients treated consecutively in our department for UI/SI with Pro-ACT® balloons between April 2006 and January 2009 (119 balloons; 1 balloon not implanted due to a vesical gap stemming from an operation). For each patient, from the 21st patient on, retrovision of the vesical neck was carried out during implantation, with a flexible cystoscope. Fifty-six patients out of 60 (93.3%) showed UI/SI after radical prostatectomy (RP). The average age at the time of implantation was 68.78 years [38–83]. The average waiting time between RP and implantation was 4.04 years [0–15]. The average number of daily protections prior to treatment was 2.3 (/47 patients) [0 condom catheter]. Sixty patients (100%) showed diurnal dribbling, and 17 patients showed nocturnal dribbling (28.3%). While 98.3% of the patients (58/59) showed dribbling during efforts, 17.2% (10/58) showed dribbling while resting. Five patients (8.5%) were given external radiotherapy (four before implantation and one afterwards). Five patients had undergone surgical treatment for UI/SI prior to implantation of the balloons (8.5%) [four artificial urinary sphincters, one Invance® sub-urethral strip]. The average follow-up period was 8.9 months (median = 7.57 months; [0.9–29.3]).ResultsFifty-one patients (85%) declared that they had found an improvement, thanks to the treatment, during one follow-up consultation at least, and such improvements were noted during several consecutive consultations (two or more) for 80.4% (41/51) of them. The average percentage of maximum improvement obtained (subjective score) in this group of 51 patients stood at 67.5%. Twenty-five of these patients (49.1%) had an improvement score lying between 80 and 100%. 23.3% of the patients were rid of their diurnal dribbling (14/60). 94.1% of the patients were rid of their nocturnal dribbling (16/17). The average number of protections reduced from 2.5 per day prior to the operation, to 1.24 per day at the end of the follow-up period for which figures are currently available (42 patients). Fourteen patients out of 42 evaluated no longer wear any protections (33.3%). The average number of postoperative adjustments per balloon and per patient stood at 2.7 [0–7]. The average total volume injected into each balloon during postoperative adjustments was 1.79 ml [0–5.7]. Complications such as pain, haematoma, acute urine retention (AUR), post-urination residue (PUR) or dysuria were noted in 40% of the patients (24/60); in most cases, they were transitory. Twenty balloons had to be explanted (16.8%) in 12 patients (20%). The reasons for explantation were as follows: four cases of urethral erosion, three failures, two infections, one split balloon, one exteriorization and one migration. 91.7% of the patients explanted (11/12) were able to undergo fresh treatment (five balloons, six artificial urinary sphincters). No major adverse events were noted in our series.ConclusionImplantation of Pro-ACT® balloons to cure male urinary incontinence due to sphincteral insufficiency is an efficient method. The complications are minor ones that are easy to deal with. The ease of adjustment and reversal shown by the treatment enables its first-line use for this pathology.