Table 1.
Summary table of penile rehabilitation trials in patients undergoing pelvic cancer surgery.
| Author (year of publication) | Study design | Type of pelvic cancer surgery | Number of patients | Penile rehabilitation modality | Active drug (dosage) | Regimen | Duration | Outcomes |
|---|---|---|---|---|---|---|---|---|
| Montorsi et al. (1997) [14] | PRCT | NSRP | 30 | ICI | Alprostadil (2.5–14 µg) | 3 times weekly starting 1 month after surgery | 12 weeks | Recovery of spontaneous EF |
| Mulhall et al. (2005) [48] | Prospective controlled nonrandomized trial | RP | 132 | PDE5I or ICI for nonresponders to PDE5I | Sildenafil (50–100 mg) and alprostadil | Daily oral PDE5I or 3 times weekly ICI for nonresponders | 18 months | 2.7 times higher spontaneous EF and statistically higher IIEF scores |
| Bannowsky et al. (2008) [49] | PRCT | NSRP | 41 | PDE5I | Sildenafil (25 mg) | Nightly low dose starting the day of catheter removal | 52 weeks | Higher spontaneous EF and statistically higher IIEF scores |
| Padma-Nathan et al. (2008) [50] | PRCT | BNSRP | 76 | PDE5I | Sildenafil (50–100 mg) | Nightly starting 4 weeks after surgery | 36 weeks | Improvement in spontaneous EF and satisfaction |
| Montorsi et al. (2004) [34, 51] | PRCT | BNSRP | 303 | PDE5I | Tadalafil (20 mg) | On demand 12 to 48 months after surgery | 12 weeks | Statistically higher IIEF scores and higher satisfaction |
| Brock et al. (2003) [52] | PRCT | NSRP | 440 | PDE5I | Vardenafil (10–20 mg) | On demand | 12 weeks | Statistically higher IIEF scores |
| Raina et al. (2006) [100] | PRCT | NSRP | 109 | VED | VED | Daily starting two weeks after surgery | 9 months | Improvement in spontaneous EF, IIEF scores, and satisfaction |
| Raina et al. (2007) [55] | Prospective controlled nonrandomized trial | NSRP | 91 | Transurethral | MUSE (125 or 250 µg) | 3 times weekly starting 3 weeks after the surgery | 9 months | Recovery of spontaneous EF |
| Köhler et al. (2007) [57] | PRCT | NSRP | 28 | VED | VED | Daily (10 mins) (immediate (1 month) versus delayed (6 months)) | 5 months | Improvement of EF and preservation of penile length |
| Montorsi et al. (2008) [61] | PRCT | BNSRP | 628 | PDE5I | Vardenafil (10 mg nightly versus 5/20 mg on demand) | 10 mg nightly versus 5/20 mg on demand | 9 months | No difference in IIEF-EF between nightly dosing and on-demand dosing |
| McCullough (2008) [30] | PRCT | NSRP | 54 | Transurethral versus PDE5I | MUSE (125 µg) versus sildenafil (50 mg) | Nightly starting 1 month after the surgery | 9 months | No differences in recovery |
| Schwartz et al. (2004) [27] | Prospective controlled nonrandomized trial | NSRP | 21 | PDE5I | Sildenafil (50 mg versus 100 mg) | Every other night beginning the day of catheter removal | 6 months | No loss of smooth muscle in 50 mg and gain of smooth muscle in 100 mg |
| Nandipati et al. (2006) [101] | Prospective controlled nonrandomized trial | NSRP | 22 | PDE5I and ICI | Sildenafil (50 mg) and alprostadil (1–4 µg) or trimix (20 U) | Sildenafil daily and ICI 2-3 times weekly at hospital discharge | 6 months | Assisted early sexual activity and satisfaction; addition of PDE5I allows lower dose of ICI |
| Zippe et al. (2004) [63] | Retrospective | RC | 49 | PDE5I | Sildenafil (?) | Not specified | Not specified | Successful vaginal penetration in 9% of patients |
| Hautmann et al. (2010) [72] | Retrospective | RC | 9 | PDE5I | Sildenafil (?) | Not specified | Not specified | Partial tumescence in 5/9 patients |
| El-Bahnasawy et al. (2008) [73] | Prospective nonrandomized trial | RC | 100 | PDE5I | Sildenafil (50–100 mg) | Daily | 4 weeks with 50 mg and then 4 weeks with 100 mg | Dose related effect |
| Nishizawa et al. (2011) [78] | Prospective nonrandomized trial | Rectal cancer surgery | 49 | PDE5I | Sildenafil (25 mg) and vardenafil (5 mg) or sildenafil (50 mg) and vardenafil (10 mg) |
On demand | Not specified | Improvement in EF in 69% of patients |
| Lindsey et al. (2002) [82] | PRCT | Rectal cancer and inflammatory bowel disease surgery | 32 | PDE5I | Sildenafil (25–50–100 mg) | Dose escalation | 4 weeks | 79% responded to sildenafil, on global efficacy assessment, compared with 17% taking placebo (P = 0.0009) |
PRCT: prospective randomized controlled trial; PDE5I: phosphodiesterase type 5 inhibitor; ICI: intracavernous injection; MUSE: medicated urethral system erection; RP: radical prostatectomy; RC: radical cystectomy; NSRP: nerve sparing radical prostatectomy; BNSRP: bilateral nerve sparing radical prostatectomy; EF: erectile function; IIEF: international index of erectile function; IIEF-EF: erectile function domain of the international index of erectile function.