ED 28. Inflatable penile implantation for erectile dysfunction: A single center experience in 13 cases

Objective: To study the efficacy, safety and reliability of inflatable penile support device for erectile dysfunction (ED).

Methods: From May 2008 to July 2011, 13 cases underwent inflatable penis support device implantation for severe ED, 9 of whom took domestic devices and 4 took imported ones. Patients aged from 28 to 47, with mean age at 38. Before operation, all cases received nocturnal penile tumescence (NPT), Doppler ultrasound of the penile vessels, fasting blood glucose, blood lipids, sex hormone tests; some patients took psychological assessment as well. According to the current NPT diagnostic criteria, International Index of Erectile Function (IIEF) and other indexes, the patients enrolled in this group have severe ED, 5 were vascular ED, 5 neurological ED, 2 mixed ED and 1 psychological ED. All these patients have taken PDE5 inhibitors and vacuum aspiration, however there was no improvement; these patients refused to take injection of vasoactive drug; the psychological ED patient insisted on penis support device implantation after psychologist assessment and fully discussion. Patients took intravenous injection of broad-spectrum antibiotics an hour before the operation, received combined spinal-epidural anesthesia, and stayed in prostration. Routine disinfection for about 15 minutes was performed. 9 cases retained foley catheter (I8 F), and 1 case took postoperative ultrasound guided suprapubic otomy due to difficulty in catheter insertion. We made transverse or longitudinal incisions about 3 cm in length over middle of penoscrotal junction, dissected subcutaneous tissue to avoid stratum cavernosum injury, separated stratum cavernosum on both sides till the albuginea, sutured over bilateral sides of albuginea with synthetic absorbable suture 2-0, longitudinally made incision over cavernosum albuginea for about 2 cm, applied special dilator to dilate bilateral cavernosum in turn, determined the length of cavernosum. Gentamicin saline was used to wash the cavernous chamber. Then we selected appropriate devices, emptied the gas, inserted artificial cylinder, coupled the sutures preset and knotted to close the cavernous incision; forefinger went through the outer margin to get the transverse fascia bluntly poked. We isolated enough space over the anterior outer space of bladder to place reservoir, injected 50 mL of normal saline; the valve was placed between testes at the bottom of the scrotum, connecting corresponding catheters. Negative pressure drainage was extracted through perineal skin, penis was maintained in semi-erection or weak, then dressed pressure and bandaged for 24 h. Drainage tubes and catheters were removed generally 24 hours later. Monitoring of blood routine was performed on the first 3 days after the operation. Patients took broad-spectrum antibiotics for intravenous injection for 7 days, and for oral use for another 7 days. For those with local pain and discomfort, we didn't administer conventional analgesic therapy in order to accurately ovserve body temperature. Postoperative follow-up took 1.5-34 months, mean at 16 months.

Results: 13 cases underwent surgery successfully; 1 case retained drainage tubes for 72 hours due to much drainage fluid; 1 pelvic fracture case received catheter removal 24 hours later after operation, but then experienced urinary retention, so urinary catheter was retained for 5 days and then removed, the incision was well healed. No infection was noted in peroperative period. 6 cases began training on filling and discharge of the artificial devices two weeks later after the operation. 1 case had skin ulcer due to plaster allergy, and the ulcer was healed after local nursing, this case began his training 3 weeks later. 1 case used Calamine Lotion 2 weeks later after operation due to eczema over thigh joint, but he washed the scrotum by mistake, so the scrotal skin ablated widely, this patient began training 4 weeks later as well after local management. The left 7 cases began their training 4-5 weeks. During follow-up, 1 case complained that he may reach orgasm for extruding and fricting for a long period of time in the female on top position, and he suddenly felt pain and the penis got weak and could not get filled during intercourse 10 months later after operation. MRI indicated scrotum fluid leakage, cylinder rupture was noted during operation exploration, so that we changed the bilateral cylinders, and gave suggestion on safe sex, so patient is now leading a normal sex life. 1 patient experienced six surgeries such as colostomy, repair of urethra-rectal fistula, and transurethral stricture scar excision because of pelvic fracture induced urethral stricture and urethra-rectal fistula, etc. he didn't have sex for two years due to erectile dysfunction. He was suggest to have his partner tested for possible sex transmitted diseases since the couple have been separated for a long time, but the patient didn't follow doctor's advice. 3 weeks later after his being with sex life, he had urinary pain, urgency and morning urethral subsistence signs. Physical examination excluded urethral erosion, and he was confirmed with non-gonococcal urethritis. Since cotton swab sampling is invasive, we recommended his partner visit dermatologist to obtain possible etiological information and drug sensitivity, but were refused. So patient received experience based treatment for two weeks and revisited several times. Patient was told to keep further consultation and pay attention to early signs of device infection when his morning urination returned normal.

Currently there is no device infection case yet. All the 13 patients are satisfied with their sex life, and five cases complained they felt their penis shortened after erection.

Conclusions: Inflatable penile implantation for refractory ED is efficient, safe and reliable; but intense friction and distortion should be avoided during intercourse, safe intercourse is also suggested.