PDE-5i & VED for penile rehabilitation after LNRP for rectal cancer: A prospective, nonrandomized, controlled trial in a single Chinese center

Haijun Deng, PhD, MD1, Hao Liu, PhD, MD1, Xiaoliang Lan, MD1, Jinhua Mo1, Xiangming Mao, PhD, MD2, Guoxin Li, PhD, MD1. 1Department of General Surgery, Nanfang Hospital, Southern Medical University, 2Department of Urologic Surgery, Peking University Shenzhen Hospital

Introduction: Effective management of male patients with erectile dysfunction (ED) secondary to rectal cancer surgery is lacking. This study was to clarify the role of phosphodiesterase-5 inhibitors (PDE-5i) and a vacuum erection device (VED) in penile rehabilitation after laparoscopic nerve-preserving radical proctectomy (LNRP) for rectal cancer (ClinicalTrials.gov Identifier: NCT01912586).

Methods and Procedures: This prospective, nonrandomized intervention study was carried out at the department of general surgery at a tertiary university hospital. Preoperatively potent male patients aged 18- 70 years, with scores on the Erectile Function domain of the International Index of Erectile Function (IIEF-5) > 21, and who underwent LNRP for rectal cancer were eligible. The participants were assigned to an arm-no intervention, nightly use of sildenafil 25-mg for 3 months after surgery or concurrent use of nightly sildenafil 25-mg/day for 3 months and a VED 10-15 minutes/day for 3 months – in a nonrandomized fashion. Treatment was started with in one or two weeks (catheter removal) after surgery to minimize penile tissue degeneration. Objective erectile function was confirmed by nocturnal penile tumescence (NPT) determined using the erectometer. All participants had a follow-up of over 12 months prospectively, and patients had baseline, 3-, 6- and 12- month assessment based on IIEF-5 or NPT.

The protocol was approved by The Institutional Review Board of Nanfang Hospital, Southern Medical University before enrollment (NFEC-2013-035), and the written informed consent must obtain from all participating patients.

Results: A total of 90 patients were enrolled and followed up in the study between April 2013 and August 2014. After excluding 19 cases lost to follow up, seventy-one cases were included in final analyses (14 in combined therapy group; 23 in single therapy group; 37 in no intervention group). The mean age was 37.0 years in combined therapy group, 42.5 years in single therapy group and 50.9 years in no intervention group (P=0.013).

In no-intervention group, the mean baseline IIEF-5 score of 21.9 decreased rapidly to 5.0 at 3 months (<0.001), 9.2 at 6 months (<0.001) and stayed at 10.9 at 12 months (P<0.001). In single therapy group, the mean baseline IIEF-5 score of 22.4 decreased dramatically to 9.0 at 3 months (P<0.001), 14.9 at 6 months (P=0.005) and stayed at 15.1 at 12 months (P=0.005). In combined therapy group, the mean baseline IIEF-5 score of 23.0 decreased slightly to 15.0 at 3 months (P=0.005), 18.0 at 6 months (P=0.038) and maintained at 18.7 at 12 months (P=0.163).

Significant differences were found in IIEF-5 scores between the three groups at 6 months (P=0.010) and 12 months (0.043) after LNRP, after adjusting for age.

Conclusions: Our findings suggested an over 50% decline in quality of erection function of the patients after LNRP, providing an opportunity to initiate early intervention with PED-5i or VED in selected patients. In present study, the early use of PED-5i alone or combined use of PED-5i and VED after LNRP maintained erectile function at 12 months. However, randomized controlled trials are warranted to further confirm the findings.

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