Does symptomatic improvement in IPSS & IIEF Scores correlates with objective changes in urodynamic parameters amongst patients with symptomatic BPH following tamsulosin/tadalafil monotherapy or combination of both? : A Prospective Study.

Mete U1, Singla K1

Research Type

Clinical

Abstract Category

Prostate Clinical / Surgical

Abstract 346
Urethra / Prostate
Scientific Podium Short Oral Session 22
On-Demand
Benign Prostatic Hyperplasia (BPH) Pharmacology Urodynamics Techniques Prospective Study
1. PGIMER, Chandigarh
Presenter
U

Uttam Mete

Links

Abstract

Hypothesis / aims of study
Erectile dysfunction(ED) and LUTS are highly prevalent and often coexist in the elderly with BPH. Recent studies have shown the efficacy of phosphodiesterase5 (PDE5) inhibitors alone and in combination with alpha-adrenergic blockers in managing lower urinary tract symptoms.  Although clinical benefit of PDE5 inhibitors has been shown, urodynamic data regarding the effect of PDE5 inhibitors is sparse. This study was designed to assess the efficacy of tamsulosin, tadalafil or a combination of the two in terms of improving LUTS, urodynamic parameters and sexual function in patients with BPH.
Study design, materials and methods
45 symptomatic BPH patients were prospectively  randomized to receive tamsulosin (Group A), tadalafil (Group B) or a combination (Group C). Patients were assessed at the start of the study and at the end of 3 months. Outcome was measured in terms of change in IPSS, QOL, IIEF-5 and urodynamic parameters including change in Qmax, Pdet Qmax, BCCI,BCI and PVR.
Results
The three groups were comparable . The mean age was 61.82±8.794 years with mean duration of LUTS were 2.51±1.576 years.  A statistically significant change in IPSS score[7.93±6.90 (p = .001) in Group A, 7.00±5.59 (p = .000) in Group B and 5.80±5.51 (p = .001)in Group C] was observed. However, there was no significant difference on intergroup comparison (p=0.628). Significant improvement in the QOL Index in Group A (p= .000) and B (p= .003) was noted. 

Statistically significant improvement  of ED was noted only in patients who received Tadalafil (Group B and C).   The mean change in Qmax, Pdet Qmax and PVR were insignificant and similar in all the three groups. The bladder outlet obstruction index (BOOI) and bladder contractility index (BCI) failed to show any significant change following therapy (Table2).  Adverse events (headache and body aches) were noted more frequently in Group C although none discontinued treatment.
Interpretation of results
Our study shows that LUTS and QOL do improve with PDE5 inhibitors and the improvement is comparable to that seen with alpha-adrenergic blockers.  Combination therapy however, failed to show any additive improvement in LUTS.   Erectile function, expectedly, improved in patients who received PDE5 inhibitors, alone or along with tamsulosin.  Tamsulosin alone did not improve erectile function.  Surprisingly, improvement in LUTS was not reflected in urodynamic studies.  Urodynamic parameters did not show any significant change after therapy in any of the three groups.  Our study suggests that factors other than changes in bladder function and prostatic resistance are involved in improving symptoms in patients with BPH.
Concluding message
Tamsulosin and tadalafil significantly improved LUTS secondary to BPH. However, combination therapy did not give added benefit. The improvement in erectile function with tamsulosin was insignificant. Therefore, for patients with symptomatic BPH with bothersome ED, monotherapy with tadalafil may be considered rather than as a combination with tamsulosin. Interesting to note that the subjective improvement in LUTS was not reflected objectively in urodynamic parameters.
Figure 1
Disclosures
Funding Nil Clinical Trial No Subjects Human Ethics Committee Institute ethics committee, PGIMER, Chandigarh Helsinki Yes Informed Consent Yes
28/04/2024 14:05:08