Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT)

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Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT)

Background: The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors (PDE5-Is) on penile function after nerve-sparing radical prostatectomy (NSRP) remains unclear.

Objective: The primary objective was to compare the efficacy of tadalafil 5mg once daily and tadalafil 20mg on demand versus placebo taken over 9 mo in improving unassisted erectile function (EF) following NSRP, as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain (IIEF-EF) score ≥ 22 after 6-wk drug-free washout (DFW). Secondary measures included IIEF-EF, Sexual Encounter Profile question 3 (SEP-3), and penile length.

Design, setting, and participants: Randomised, double-blind, double-dummy, placebo-controlled trial in men ≤ 68 yr of age with adenocarcinoma of the prostate (Gleason ≤ 7) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada.

Interventions: 1:1:1 randomisation to 9 mo of treatment with tadalafil 5mg once daily, tadalafil 20mg on demand, or placebo followed by a 6-wk DFW and 3-mo open-label tadalafil once daily (all patients).

Outcome measurements and statistical analysis: Logistic regression, mixed-effects model for repeated measures, and analysis of covariance, adjusting for treatment, age, and country, were applied to IIEF-EF scores ≥ 22, SEP-3, and penile length.

Results and limitations: Four hundred twenty-three patients were randomised to tadalafil once daily (n=139), on demand (n=143), and placebo (n=141). The mean age was 57.9 yr of age (standard deviation: 5.58 yr); 20.9%, 16.9%, and 19.1% of patients in the tadalafil once daily, on demand, and placebo groups, respectively, achieved IIEF EF scores ≥ 22 after DFW; odds ratios for tadalafil once daily and on demand versus placebo were 1.1 (95% confidence interval [CI], 0.6-2.1; p=0.675) and 0.9 (95% CI, 0.5-1.7; p=0.704). At the end of double-blind treatment (EDT), least squares (LS) mean IIEF-EF score improvement significantly exceeded the minimally clinically important difference (MCID: ΔIIEF-EF ≥ 4) in both tadalafil groups; for SEP-3 (MCID ≥ 23%), this was the case for tadalafil once daily only. Treatment effects versus placebo were significant for tadalafil once daily only (IIEF-EF: p=0.016; SEP-3: p=0.019). In all groups, IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment. At month 9 (EDT), penile length loss was significantly reduced versus placebo in the tadalafil once daily group only (LS mean difference 4.1mm; 95% CI, 0.4-7.8; p=0.032).

Conclusions: Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP, and data suggest a potential role for tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes. Unassisted EF was not improved after cessation of active therapy for 9 mo.

Trial registration: ClinicalTrials.gov identifier NCT01026818.

Keywords: Clinical trials; Erectile dysfunction; Nerve-sparing prostatectomy; Penile function; Phosphodiesterase type 5 inhibitors; Prostate cancer; Radical prostatectomy; Rehabilitation; Tadalafil once a day.

Comment in

Burnett AL. Burnett AL. Eur Urol. 2014 Mar;65(3):597-8. doi: 10.1016/j.eururo.2013.10.018. Epub 2013 Oct 28. Eur Urol. 2014. PMID: 24268502 No abstract available.

Brock G, Montorsi F, Büttner H, Henneges C, Mulhall J. Brock G, et al. Eur Urol. 2014 Mar;65(3):598-9. doi: 10.1016/j.eururo.2013.11.015. Epub 2013 Nov 19. Eur Urol. 2014. PMID: 24287317 No abstract available.

Cited by

Shao J, Nie P, Yang W, Guo R, Ding D, Liang R, Wei B, Wei H. Shao J, et al. Bioeng Transl Med. 2022 May 31;7(3):e10319. doi: 10.1002/btm2.10319. eCollection 2022 Sep. Bioeng Transl Med. 2022. PMID: 36176612 Free PMC article.

Kadono Y, Nohara T, Kawaguchi S, Iwamoto H, Yaegashi H, Shigehara K, Izumi K, Mizokami A. Kadono Y, et al. Cancers (Basel). 2022 Jun 21;14(13):3050. doi: 10.3390/cancers14133050. Cancers (Basel). 2022. PMID: 35804823 Free PMC article. Review.

Jang SW, Chung JW, Kwon TG. Jang SW, et al. Int J Impot Res. 2022 Jul 7. doi: 10.1038/s41443-022-00591-3. Online ahead of print. Int J Impot Res. 2022. PMID: 35799062 No abstract available.

Noh TI, Shim JS, Kang SG, Cheon J, Lee JG, Kang SH. Noh TI, et al. Sex Med. 2022 Jun;10(3):100508. doi: 10.1016/j.esxm.2022.100508. Epub 2022 Apr 6. Sex Med. 2022. PMID: 35395569 Free PMC article.

Jang SW, Lee EH, Chun SY, Ha YS, Choi SH, Lee JN, Kim BS, Kim HT, Kim SH, Kim TH, Yoo ES, Chung JW, Kwon TG. Jang SW, et al. Int J Impot Res. 2022 Mar 28. doi: 10.1038/s41443-022-00560-w. Online ahead of print. Int J Impot Res. 2022. PMID: 35347300

Efficacy and safety of tadalafil for erectile dysfunction in patients with multiple sclerosis

Introduction: Data are sparse concerning the effects of phosphodiesterase type 5 (PDE5) inhibitors for erectile dysfunction (ED) in subjects with multiple sclerosis (MS).

Aim: To evaluate the efficacy and safety of tadalafil use in subjects with ED because of MS.

Methods: Ninety-six MS patients with ED after a 4-week treatment-free period were given tadalafil 10 mg. All patients were re-evaluated after 4 weeks. Those with a score lower than 26 on the International Index of Erectile Function (IIEF-15) and with less than 75% of total successful sexual attempts assessed by the Sexual Encounter Profile Questions 2 and 3 (SEP2-3) had their dosage of tadalafil increased to 20 mg, whereas responding subjects continued with 10 mg. Subsequently, all patients had a final follow-up visit after 8 weeks.

Main outcome measures: SEP2-3, IIEF-15 questionnaire. The Life Satisfaction Checklist (LSC) questionnaire composed of eight questions was used prior to starting tadalafil and at the end of the 12-week treatment.

Results: Ninety-two subjects completed the study. Seventy-two responded, 30 of whom used 10 mg. Two subjects discontinued the therapy because of moderate side effects: one suffered from headache and one from tachycardia. Responding patients reached a significant statistical improvement in all follow-ups compared with baseline on the erectile domain and overall sexual satisfaction scores of the IIEF-15 using the Wilcoxon test P < 0.01. Furthermore, they showed statistical improvement through the Wilcoxon test P < 0.01 on the sexual life, family life, and partner relationship questions of the LSC compared with baseline.

Conclusion: Tadalafil is an effective and safe treatment for males with MS suffering from ED. Further studies are needed on MS patients to evaluate the efficacy and safety of long-term use, and to detect predictable parameters for the success of PDE5 inhibitors.

Comment in

Zhang HL, Pan W, Wu J. Zhang HL, et al. J Sex Med. 2011 Apr;8(4):1257-8. doi: 10.1111/j.1743-6109.2010.01919.x. J Sex Med. 2011. PMID: 20584118 No abstract available.

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Afshar B, Amini L, Hasani M, Jahanfar S, Massood Nabavi S. Afshar B, et al. Int J Reprod Biomed. 2022 May 23;20(4):241-254. doi: 10.18502/ijrm.v20i4.10897. eCollection 2022 Apr. Int J Reprod Biomed. 2022. PMID: 35822180 Free PMC article. Review.

Massarotti C, Sbragia E, Gazzo I, Stigliani S, Inglese M, Anserini P. Massarotti C, et al. J Clin Med. 2021 Nov 19;10(22):5401. doi: 10.3390/jcm10225401. J Clin Med. 2021. PMID: 34830684 Free PMC article. Review.

Gopal A, Sydow R, Block V, Allen DD. Gopal A, et al. Int J MS Care. 2021 Sep-Oct;23(5):213-222. doi: 10.7224/1537-2073.2020-039. Epub 2021 Mar 10. Int J MS Care. 2021. PMID: 34720761 Free PMC article.

Bientinesi R, Gandi C, Bassi P. Bientinesi R, et al. Int Neurourol J. 2020 Jun;24(2):118-126. doi: 10.5213/inj.2040028.014. Epub 2020 Jun 30. Int Neurourol J. 2020. PMID: 32615673 Free PMC article.

Drulovic J, Kisic-Tepavcevic D, Pekmezovic T. Drulovic J, et al. Acta Neurol Belg. 2020 Aug;120(4):791-797. doi: 10.1007/s13760-020-01323-4. Epub 2020 Mar 11. Acta Neurol Belg. 2020. PMID: 32162189 Review.

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Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT)

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Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT)

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