Evaluation of a Progressive Treatment Program for Erectile Dysfunction in Patients with Diabetes Mellitus

S. Israilov; J. Shmuely; E. Niv; D. Engelstein; P. Livne; J. Boniel

Disclosures

Int J Impot Res. 2005;17(5):431-436. 

In This Article

Results

Analysis of the IIEF scores before the treatment showed that 126 patients (44.4%) had severe ED, 106 (37.3%) moderate ED, and 52 (18.3%) mild-moderate ED. Five patients (1.8%) have had ED for 6 months to 1 y, 38 (13.4%) for 1-2 y, 117 (41.2%) for 2-5 y, 88 (31%) for 5-10 y, and 36 (12.7%) for 10-14 y. Mean duration was 2.5±0.9 y.

Phase 1. Of the 284 patients, eight were excluded from the sildenafil citrate phase as a precaution because of intensive laser treatment for severe retinopathy on the basis of ophtalmologist's request. Of the remaining 276 patients receiving sildenafil citrate, a positive response was noted in 147 (53.3%). In all, 25 patients (9.1%) had adverse effects, including facial flushing (n=12, 4.3%), headache (n=9, 3.3%), dizziness (n=3, 1.1%), and abnormal vision (n=1, 0.4%) and stopped sildenafil citrate after short time. Therefore 122 (44.2%) patients were able to continue this treatment.

See Table 2 .

Phase 2. Vacuum therapy with the VED was attempted in 162 patients: 129 who failed to respond to sildenafil citrate+25 with adverse effects to sildenafil+8 with retinopathy. After 2-3 sessions at intervals of 2-3 days, 114 patients (70.4%) showed a positive response. In all, 13 of them (8%), however, complained of severe pain from even the largest tension ring, and in 17 (10.5%) decreased penile rigidity to 1-2 min even with the smallest ring. Only 19 (11.7%) agreed to use the VED under domestic conditions.

Phase 3. A total of 143 patients were given ICI with vasoactive drugs: 48 patients who failed phase 2, 30 who had pain or rigidity during VED, 65 who refused the VED for home use despite a good response.

In all, 64 patients (44.8%) responded positively to the first ICI dose of papaverine 12 mg+phentolamine 1 mg+prostaglandin E1 10 µg. The duration of the response was 65.6±3.2 min. An additional 66 patients (46.2%) responded to the ICI, but had pain during erection. In these cases, the dose of prostaglandin E1 was reduced to 6 µg, and the doses of papaverine and phentolamine were increased to 17 and 1.5 mg, respectively. In the nonresponders to the first injection, the dose of prostaglandin E1 was increased as well, to 12.2±4.5 µg. There were 29/79 (36.7%) responders to the second injection, with a mean response duration of 50.4±2.5 min. The remaining 50 patients received a third injection of papaverine 25 mg+phentolamine 2 mg+prostaglandin E1 18.4±4.6 µg, and 10 (20%) responded. The duration of the positive response was 44.1±2.4 min. The total number of patients with a positive mean response at the end of phase 3 was 103 (72%).

Phase 4. In all, 40 patients received sildenafil 50 mg followed by ICI with papaverine 25 mg+ phentolamine 2 mg+prostaglandin E1 15.4±5 µg. In all, 17 (42.5%) patients responded, with a response duration of 48.5±5.5 min. A total of 23 nonresponders received sildenafil 100 mg followed by ICI at the same doses. In all, 10 patients (25%) responded to this increased dose with response duration of 31.4±1.2 min. Four patients (17.4%) complained of slight dizziness. A total of 13 patients were considered as nonresponders in this phase.

Phase 5. In all, 13 patients went on to receive papaverine 16 mg+phentolamine 1.5 mg+prostaglandin E1 15.2±3.4 µg followed by the VED. After two sessions at intervals of 3-5 days, nine (69.2%) showed a positive response.

Phase 6. The remaining four patients agreed to an inflatable two-piece (three patients) or three-piece (one patient) penile prosthesis. All performed successful coitus 8-10 weeks after surgery.

Of the 43 patients receiving insulin, 37 were eligible for sildenafil citrate treatment, and nine (24.3%) responded. In all, 22 (64.7%) of 34 responded to the ICI, 4/12 (33.3%) to sildenafil +the ICI, 2/8 (25%) to ICI+VED and the remaining four underwent a penile implant. Of the 17 patients (70.6%) in whom penile rigidity decreased after VED, 12 were receiving insulin.

During the 2 y follow-up after 284 patients, the ED treatment was changed as necessary, according to the same 6-phase program. The reasons for transition from one treatment modality to another were different. In all, 11 patients were referred for penile implantation due to failure of other options during this period of time. Of the 19 patients (63.2%) who received the VED, 12 were asked to switch to another form of treatment during follow-up because their partner complained of a cold sensation during vaginal penetration. Examination of these patients in glands penis with an electrothermometer showed that at 1-2 min before vacuum therapy, penile temperature was 30.4±0.9°C, and after 10-12 min, it dropped to 24.4±0.4°C (P<0.05). After ICI in 6/113 patients (5.3%), small nodules appeared and treatment was stopped for 1.0-1.5 months, during which time vacuum therapy was used. The nodules disappeared within this period in all patients.

At the end of 2 y, 81 of 284 patients who entered the study (28.5%) were performing successful coitus with sildenafil citrate, seven (2.5%) with VED, 113 (39.8%) with ICI, 24 (8.5%) with sildenafil+ICI, two (0.7%) with ICI+VED and 15 (5.3%) with a penile prosthesis. In all, 17 (6%) patients reported spontaneous erections. A total of 14 (5%) patients had a negative response to all treatments. All of them had diabetic complications and comorbidities, including six (42.9%) receiving insulin, aged 70-78 y. In all, 11 (3.9%) patients stopped treatment despite an initial positive response: five were divorced, two were widowed, and four had an ill wife. In general, after 2 y, 259 (91.2%) were achieving coitus.

Total mean IIEF score before treatment was 16.48±6.41, and after 2 y of follow-up, 58.64± 11.78 (P<0.001). Comparison of the mean response to five domains of the IIEF between baseline and termination of the 2 y follow-up is shown in Table 3 .

Doppler ultrasound was performed in 17 patients with decreased rigidity with rings (VED). Peak systolic velocity (mean±s.d.) before ICI was 16.7± 1.5 cm/s, after 5 min 46.6±2.8 cm/s (P<0.001), after 15 min 24.3±1.6 cm/s (P<0.0001). Peak diastolic velocity before ICI was 3.5±0.2, after 5 min 8.9±0.3 (P<0.05) and after 15 min 4.2±0.4 cm/s (P<0.05). We assumed these patients had venous leakage. Accordingly, in the 12 patients who reported spousal complaints of cold sensation, electrothermometry revealed a significant drop from 30.4±0.9°C before vacuum therapy to 24.4±0.4°C at 10-12 min after cylinder removal but not when the rings were removed (P<0.05).

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....