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Article of the week: No difference in sexual function seen between monopolar and bipolar TURP

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Bipolar vs monopolar transurethral resection of the prostate: evaluation of the impact on overall sexual function in an international randomized controlled trial setting

Charalampos Mamoulakis1,2, Andreas Skolarikos3, Michael Schulze4, Cesare M. Scoffone5, Jens J. Rassweiler4, Gerasimos Alivizatos3, Roberto M. Scarpa5 and Jean J.M.C.H. de la Rosette1

1Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands, 2Department of Urology, University Hospital of Heraklion, University of Crete Medical School, Heraklion, Crete, Greece, 3Second Department of Urology, Sismanoglio Hospital, University of Athens Medical School, Athens, Greece, 4Department of Urology, SLK Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany, and 5Department of Urology, San Luigi Hospital, University of Turin, Orbassano, Turin, Italy

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OBJECTIVE

• To compare monopolar and bipolar transurethral resection of the prostate (M-TURP and B-TURP, respectively) using a true bipolar system, for the first time in an international multicentre double-blind randomized controlled trial focusing on the overall sexual function quantified with the International Index of Erectile Function Questionnaire (IIEF-15). Other baseline/perioperative parameters potentially influencing erectile function (EF) after TURP were secondarily investigated.

MATERIALS AND METHODS

• From July 2006 to June 2009, consecutive TURP candidates with benign prostatic obstruction were prospectively recruited in four academic urological centres, randomized 1:1 into M-TURP/B-TURP arms and followed up at 6 weeks, 6 and 12 months after surgery. In all, 295 eligible patients were enrolled.

• Overall sexual function was quantified using self-administered IIEF-15 at baseline and at each subsequent visit.

•  Total IIEF/domain scores were calculated and EF score classified erectile dysfunction severity. Differences in erectile dysfunction severity at each visit compared with baseline (EF evolution), classified patients into ‘improved’, ‘stable’ or ‘deteriorated’.

•  Pre-postoperative IIEF/domain scores and differences in the distribution of EF evolution were compared between arms throughout follow-up.

RESULTS

• In all, 279 patients received the allocated intervention; 218/279 patients (78.1%) provided complete IIEF-15 data at baseline and were considered in sexual function analysis. Complete IIEF-15 data were available from 193/218 (88.5%), 186/218 (85.3%) and 179/218 (82.1%) patients at 6 weeks, 6 months and 12 months, respectively.

• Sexual function did not differ significantly between arms during follow-up (scores: IIEF, P = 0.750; EF, P = 0.636; orgasmic function, P = 0.868; sexual desire, P = 0.735; intercourse satisfaction, P = 0.917; overall satisfaction, P = 0.927).

• Resection type was not a predictor of any sexual function changes observed.

• Distribution of EF evolution did not differ between arms at any time (M-TURP vs B-TURP at 12 months: improved, 23/87 [26.4%] vs 18/92 [19.6%]; stable, 53/87 [60.9%] vs 56/92 [60.8%]; deteriorated, 11/87 [12.7%] vs 18/92 [19.6%]; P = 0.323).

CONCLUSION

• There were no differences between M-TURP/B-TURP in any aspect of sexual function.

 

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Editorial: Equivalent outcomes for monopolar and bipolar TURP; but are we overlooking the potential for improvement in sexual function after surgery?

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Both BPH and sexual function (SF) have a major impact on quality of life in older men. Sexual dysfunction is a complex process encompassing both erectile and ejaculatory dysfunction, as well as reduced libido and difficulty achieving orgasm. Whilst retrograde ejaculation is an almost inevitable consequence of TURP, the evidence that TURP causes erectile dysfunction is conflicting. This is probably attributable, at least in part, to a lack of high-quality historical data. Studies now show that LUTS is a risk factor for sexual dysfunction, and we are becoming increasingly aware of the relationship that exists between LUTS, depression and sexual dysfunction.

Given the favourable safety profile of bipolar TURP (b-TURP), it is perhaps a surprise that this latest study from Mamoukalis et al. has failed to demonstrate any difference in outcomes with regard to the deterioration in SF after surgery. The authors should be praised for their attempts to examine in fine detail (using the International Index of Erectile Function [IIEF]-15 in this case) any potential differences between b-TURP and monopolar TURP (m-TURP).

The design of the bipolar system is such that tissue is removed at a lower temperature and therefore the likelihood of damage to surrounding tissues and nerves is reduced. Several randomized trials have compared b-TURP with m-TURP, but only a small number have looked specifically at sexual variables in a randomized setting. This multicentre study by Mamoukalis et al. randomized 279 men to one of the two resection techniques, looking specifically at overall SF quantified by the IIEF-15. No differences were detected in any aspect of SF; erectile function (EF) improved in 26.4% of patients in the m-TURP group compared with 19.6% in the b-TURP group, and remained stable in 60.9 and 60.8% of patients, respectively. A deterioration in EF was apparent in 12.7% of the m-TURP group compared with 19.6% of the b-TURP group (P = 0.323). These results mirror those of a similar randomized study by Akman et al. comparing a quasi-bipolar system with m-TURP. They demonstrated equivalence for all measured variables except for operating time and a 1.4% incidence of TUR syndrome in the m-TURP group. In their study, the EF domain of the IIEF-15 was measured before and after surgery. EF worsened in 17% of men, improved in 28.2% and was unchanged in 54.8%. A comparative evaluation of EF was performed in a sub-group of 188 sexually active non-catheterized men of whom 18.2% developed de novo erectile dysfunction.

The explanation for the equivalent outcomes is unclear and further investigation is required. Does the failure of bipolar TURP to demonstrate a benefit with regard to SF leave the door open for the competing minimally invasive laser technologies? The overall impact of the holmium laser compared with that of TURP appears to be equivalent, with a mean of 7.5 and 7.7% of patients reporting decreased erectile function, and 7.1 and 6.2% of patients reporting increased function after each surgery. From the data available thus far, it would also appear that photoselective vaporization of the prostate similarly has no overall deleterious impact on SF when compared with TURP in a randomized trial. Further randomized data are pending and are of course of great importance if we are to understand better how the procedures we perform for symptomatic BPH affect our patients. As technological advances are made the hope is that the ‘damaging’ effects of BPH surgery on overall SF (particularly EF) will reduce further, but it may indeed be that we are searching for small margins when our attention might be better focused on maximizing the likelihood of a positive outcome, facilitated by considering the preoperative status (general health as well as urinary and sexual function), aided by the use of validated questionnaires. A better appreciation and understanding of the factors that may increase the risk of ED after surgery (age, diabetes, metabolic syndrome, obesity, cardiovascular disease and psychological factors) will enable us to manage expectations more effectively. A shorter hospital stay with minimal postoperative discomfort and an early return to normal activities, coupled with good symptomatic improvement in the longer term can only serve to be of benefit with regard to improving SF outcomes.

One recent study reporting both the short-, medium- and long-term effects of TURP on SF highlighted the high incidence of LUTS before treatment with 57% overall reporting ED before surgery. Those with severe LUTS were much more likely to have significant sexual dysfunction before surgery. This study also demonstrated a 15% improvement in pre-existing ED which was related to the improvement in LUTS after TURP.

On reflection, therefore, it would seem reasonable to conclude from the evidence presented that, although retrograde ejaculation frequently occurs after outflow surgery, erectile function is as likely to improve as it is to deteriorate. By focusing on the specific patient characteristics for each individual case before surgery it is possible we can improve the proportion of patients achieving a favourable outcome. When counselling patients before surgery regarding SF we should therefore remember to include the potential benefits as well as the risks. Furthermore, for those patients particularly anxious about the possibility of worsening SF, a ‘lesser’ surgical procedure, which might not achieve a transurethral resection-like cavity should perhaps be considered as a compromise. However, a surgical alternative which is not equivalent to TURP may indeed reduce the likelihood of improving erectile function, given the interrelationship that appears to exist between LUTS and SF.

Richard Hindley
Department of Urology, Hampshire Hospitals NHS Foundation Trust, Basingstoke, Hampshire, UK.

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Article of the Week: Does tadalafil improve ejaculatory dysfunction?

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of  Darius Paduch discussing his paper.

If you only have time to read one article this week, it should be this one.

Effects of 12 weeks of tadalafil treatment on ejaculatory and orgasmic dysfunction and sexual satisfaction in patients with mild to severe erectile dysfunction: integrated analysis of 17 placebo-controlled studies

Darius A. Paduch*†, Alexander Bolyakov*†, Paula K. Polzer‡ and Steven D. Watts‡

*Department of Urology and Reproductive Medicine,Weill Cornell Medical College, New York, NY, †Consulting Research Services, Inc., Red Bank, NJ, and ‡Lilly Research Laboratories, Eli Lilly, Indianapolis, IN, USA

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Weill Cornell Medical College Press Release

OBJECTIVES

• To compare effects of tadalafil on ejaculatory and orgasmic function in patients presenting with erectile dysfunction (ED).

• To determine the effects of post-treatment ejaculatory dysfunction (EjD) and orgasmic dysfunction (OD) on measures of sexual satisfaction.

PATIENTS AND METHODS

• Data from 17 placebo-controlled 12-week trials of tadalafil (5, 10, 20 mg) as needed in patients with ED were integrated.

• EjD and OD severities were defined by patient responses to the International Index of Erectile Function, question 9 (IIEF-Q9; ejaculation) and IIEF-Q10 (orgasm), respectively.

• Satisfaction was evaluated using the intercourse and overall satisfaction domains of the IIEF and Sexual Encounter Profile question 5.

• Analyses of covariance were performed to compare mean ejaculatory function and orgasmic function, and chi-squared tests evaluated differences in endpoint responses to IIEF-Q9 and IIEF-Q10.

RESULTS

• A total of 3581 randomized subjects were studied.

• Treatment with tadalafil 10 or 20 mg was associated with significant increases in ejaculatory and orgasmic function (vs placebo) across all baseline ED, EjD, and OD severity strata.

• In the tadalafil group, 66% of subjects with severe EjD reported improved ejaculatory function compared with 36% in the placebo group (P < 0.001).

• Similarly, 66% of the tadalafil-treated subjects (vs 35% for placebo; P < 0.001) with severe OD reported improvement.

• Residual severe EjD and OD after treatment had negative impacts on sexual satisfaction.

• Limitations of the analysis include its retrospective nature and the use of an instrument (IIEF) with as yet unknown performance in measuring treatment responses for EjD and OD.

CONCLUSIONS

• Tadalafil treatment was associated with significant improvements in ejaculatory function, orgasmic function and sexual satisfaction.

• Proportions of subjects reporting improved ejaculatory or orgasmic function were ª twofold higher with tadalafil than with placebo.

• These findings warrant corroboration in prospective trials of patients with EjD or OD (without ED).

 

Read Previous Articles of the Week

Editorial: Phosphodiesterase Inhibitors (PDEi) improve orgasm. The power of meta-analysis?

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Ever since the potential utility of meta-analyses in the assessment of clinical data was brought to the notice of the urological community by Peter Boyle [1], they have been used increasingly. Indeed this approach to evaluation of drug effects has become de rigueur for healthcare providers and regulatory bodies. In particular, invaluable insight has been given into the benefit : risk ratios of drugs in BPH/LUTS and overactive bladder. Even to the extent, where sufficiently large databases have been made available, it has been possible to identify characteristics predictive of subpopulations of responders and non-responders [1].

The most recent example of the power of meta-analysis is the rigorous statistical dissection of the impact tadalafil on sexual function in erectile dysfunction (ED) by the Department of Urology atWeill Cornell published in BJUI [2]. As would be anticipated from previously published individual clinical trials, there was confirmation in this review of 3581 subjects in 17 placebo-controlled studies, of the positive effect of tadalafil (exemplifying the phosphodiesterase inhibitor [PDEi] class) on erectile function. It could perhaps be argued that with a clinical effect as large and clear-cut as that of PDEi in ED, the meta-analysis was superfluous. Only in situations where the clinical impact beyond that of placebo was of lower magnitude does it come to the fore, e.g. a-adrenoceptor antagonists in the treatment of LUTS [3]. However, at this point the following health warning should be issued, PDEi in the hands of the skilled meta-analysts and marketeers: caveat lector (let the reader beware).
Returning, however, to the material in hand, the analysis of the tadalafil data also shows unequivocally that there is an additional positive effect of the drug (and presumably the PDEi class) on orgasm and sexual satisfaction. These products and class attributes have often been alluded to with varying degrees of conviction, but this is the first time convincing evidence has been tabulated and documented.

Also described is the positive effect of tadalafil on co-morbid ejaculatory dysfunction (EjD) which, at first sight, would tend to provide supportive evidence for the off-label use of tadalafil and other PDEi in the treatment of premature ejaculation (PE). Although the words in the manuscript [3] fall short of advocating this practice, the inference is there for all to read and potentially be detailed astutely by the field-force.We now move into the ‘grey’ area between caveat lector and caveat emptor (let the buyer beware). EjD can mean different things to different men and can represent a continuum from premature to delayed or even anejaculation. Almost certainly most of the patients in the clinical trials analysed would not meet the definition of PE crafted by the International Society for Sexual Medicine (ISSM) [4], so little conclusion about the benefit to men with PE can be drawn.

Ironically, a meta-analysis on the impact of PDEi on men with unequivocal PE (or at least meet the ISSM definition) has just been published [5]. The conclusion was that there is no clinically or statistically significant improvement in PE with acute or chronic treatment with PDEi.

Although, at least in the case of ejaculatory function the conclusion of the two meta-analyses appear to be at variance, in actuality they are addressing different questions. It remains, that, although in the use of meta-analysis we have the means of creating a level playing field, we have to be careful to consider what questions are being asked, by whomand with what objective.

References
1 Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology 1996; 48: 398–405
2 Paduch DA, Bolyakov A, Polzer PK, Watts SD. Effects of 12 weeks of tadalafil treatment on ejaculatory and orgasmic dysfunction and sexual satisfaction in patients with mild to severe erectile dysfunction: integrated analysis of 17 placebo-controlled studies. BJU Int 2013; 111: 333–42
3 Boyle P, Robertson C, Manski R, Padley RJ, Roehrborn CG. Meta-analysis of randomized trials of terazosin in the treatment of benign prostatic hyperplasia. Urology 2001; 58: 717–22
4 McMahon CG, Althof S, Waldinger MD et al. International Society for Sexual Medicine Ad Hoc Committee for Definition of Premature Ejaculation. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. BJU Int 2008; 102: 338–50
5 Asimakopoulos AD, Miano R, Agrò EF, Vespasiani G, Spera E. Does current scientific and clinical evidence support the use of phosphodiesterase type 5 inhibitors for the treatment of premature ejaculation? A systematic review and meta-analysis. J Sex Med 2012; 9: 2404–16

Mike Wyllie
Plethora Solutions Ltd London, London, UK.
e-mail: [email protected]

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Dr Paduch’s commentary on tadalafil and ejaculatory dysfunction

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Effects of 12 weeks of tadalafil treatment on ejaculatory and orgasmic dysfunction and sexual satisfaction in patients with mild to severe erectile dysfunction: integrated analysis of 17 placebo-controlled studies

Darius A. Paduch*†, Alexander Bolyakov*†, Paula K. Polzer‡ and Steven D. Watts‡

*Department of Urology and Reproductive Medicine,Weill Cornell Medical College, New York, NY, †Consulting Research Services, Inc., Red Bank, NJ, and ‡Lilly Research Laboratories, Eli Lilly, Indianapolis, IN, USA

Read the full article
OBJECTIVES

• To compare effects of tadalafil on ejaculatory and orgasmic function in patients presenting with erectile dysfunction (ED).

• To determine the effects of post-treatment ejaculatory dysfunction (EjD) and orgasmic dysfunction (OD) on measures of sexual satisfaction.

PATIENTS AND METHODS

• Data from 17 placebo-controlled 12-week trials of tadalafil (5, 10, 20 mg) as needed in patients with ED were integrated.

• EjD and OD severities were defined by patient responses to the International Index of Erectile Function, question 9 (IIEF-Q9; ejaculation) and IIEF-Q10 (orgasm), respectively.

• Satisfaction was evaluated using the intercourse and overall satisfaction domains of the IIEF and Sexual Encounter Profile question 5.

• Analyses of covariance were performed to compare mean ejaculatory function and orgasmic function, and chi-squared tests evaluated differences in endpoint responses to IIEF-Q9 and IIEF-Q10.

RESULTS

• A total of 3581 randomized subjects were studied.

• Treatment with tadalafil 10 or 20 mg was associated with significant increases in ejaculatory and orgasmic function (vs placebo) across all baseline ED, EjD, and OD severity strata.

• In the tadalafil group, 66% of subjects with severe EjD reported improved ejaculatory function compared with 36% in the placebo group (P < 0.001).

• Similarly, 66% of the tadalafil-treated subjects (vs 35% for placebo; P < 0.001) with severe OD reported improvement.

• Residual severe EjD and OD after treatment had negative impacts on sexual satisfaction.

• Limitations of the analysis include its retrospective nature and the use of an instrument (IIEF) with as yet unknown performance in measuring treatment responses for EjD and OD.

CONCLUSIONS

• Tadalafil treatment was associated with significant improvements in ejaculatory function, orgasmic function and sexual satisfaction.

• Proportions of subjects reporting improved ejaculatory or orgasmic function were ª twofold higher with tadalafil than with placebo.

• These findings warrant corroboration in prospective trials of patients with EjD or OD (without ED).

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