madman
Super Moderator
Abstract
Background: Sexual dysfunction is a common side effect of medical therapy for benign prostatic hyperplasia (BPH), whereas prostatic urethral lift (PUL) offers safe and effective relief of lower urinary tract symptoms while preserving sexual function.
Objective: To compare the long-term impact on the sexual health of PUL or daily medical therapy of doxazosin or finasteride alone or in combination in BPH patients.
Design, setting, and participants: This was a comparative analysis of sexual function outcomes from PUL studies (L.I.F.T. [n = 107], Crossover [n = 42], and MedLift [n = 39]) and the Medical Therapy of Prostatic Symptoms (MTOPS) trial. The men included were sexually active with International Prostate Symptom Score 13, Qmax 12 ml/s, and prostate volume 30–80 cm3. MTOPS subjects completed the Brief Male Sexual Function Inventory, while PUL subjects completed the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function.
Outcome measurements and statistical analysis: Mean percentage changes from baseline in erectile, ejaculatory, and sexual satisfaction domains were compared at 12, 24, 36, and 48 mo.
Results and limitations: PUL significantly improved erectile function through 24 mo, and ejaculatory function and sexual satisfaction across all time points. Medical therapy did not improve sexual function at any time point. Finasteride significantly decreased erectile function at 48 mo, and combined therapy significantly reduced ejaculatory function at 12 and 24 mo. Comparatively, PUL was superior to finasteride in preserving erectile function at 24 and 48 mo and superior to doxazosin and combined therapy at 12 mo. PUL outperformed all three medical therapies at all time points in improving ejaculatory function and sexual satisfaction. Limitations include the use of distinct patient-reported questionnaires and narrowed data on comorbidities that influence male sexual function.
Conclusions: Indirect comparison reveals that PUL is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction.
Patient summary: In our non–head-to-head study, only patients undergoing PUL for an enlarged prostate experienced improvements in sexual health. Conversely, patients on medical therapy experienced worsening of erectile and ejaculatory function.
1. Introduction
Sexual activity is highly prevalent among aging men and is an important aspect of their quality of life (QoL) [1]. Consequently, common age-related conditions that affect male sexual activity, including erectile dysfunction (ED), ejaculatory dysfunction (EjD), and benign prostatic hyperplasia (BPH), may have overlapping patient populations who are enduring repercussions such as anxiety and depression resulting from diminished QoL [2,3].
The prevalence of BPH among men amounts to 50% at age 50 yr and is as high as 90% at 80 yr of age [4]. Of this population, approximately 50% are at high risk of developing age-related sexual dysfunction [5]. The association between lower urinary tract symptoms (LUTS) and sexual dysfunction has been consistently demonstrated in multiple epidemiological and clinical studies, and it has been found that LUTS is one of the strongest predictors of male sexual dysfunction [1,6]. From a clinical perspective, the impact of BPH interventions on male sexual function has become increasingly relevant, with the American Urological Association and European Association of Urology now recommending that patients be assessed and counseled about their sexual health before and after treatment [7,8].
Within the treatment space for LUTS/BPH, a blockers and 5a-reductase inhibitors (5-ARIs), either alone or in combination, have gained a stronghold as first-line therapy. Although they have demonstrated clinical efficacy, their use has been associated with sexual side effects, which vary in rate among different drug classes and between members in the same class [9,10]. For example, 5-ARIs have been associated with sexual adverse events such as ED, EjD, change in libido, and gynecomastia. Alpha-blockers have been linked to impaired ejaculation where the super-selective tamsulosin and silodosin have been associated with EjD, including lower ejaculate volume and anejaculation [9].
Conversely, the prostatic urethral lift (PUL) procedure using UroLift System implants is the only leading minimally invasive surgical therapy that offers rapid, significant, and durable symptom relief of LUTS without causing new sustained ED or EjD [11–15]. The safety profile, which consists of mild to moderate side effects that typically resolve by 2–4 wk, and effectiveness of PUL have been established in multiple clinical studies, as well as in the real-world setting in more than 1400 patients [11,12,14– 16]. Non–head-to-head comparisons have demonstrated a mean International Prostate Symptom Score (IPSS) reduction of 10.6–11.4 points at 12 mo after PUL, versus 3.5–7.5 points with medication [11,12,17].
In this comparative analysis examining the impact of PUL or medical therapy on male sexual health, we challenge the idea that medical therapy is the most conservative, minimally invasive treatment option for BPH patients. Erectile, ejaculatory, and sexual satisfaction outcomes for sexually active men from three separate PUL clinical studies are combined and compared to results from the Medical Therapy of Prostatic Symptoms (MTOPS) trial, one of the largest and longest trials to assess the effects of medication on BPH progression [18]
3. Results
3.1. Baseline demographics
3.2. Sexual function outcomes
3.3. Erectile function
3.4. Ejaculatory function
3.5. Sexual satisfaction
4. Discussion
4.1. a blockers
4.2. 5-ARIs
4.3. Combination therapy
4.4. PUL
5. Conclusions
The long-term effects on sexual health in BPH patients following treatment with PUL or once-daily medical therapy reveal that PUL provides a safe and effective alternative for men who are currently underserved by medical therapy and who wish to maintain and possibly improve sexual function, a key aspect of an individual’s health and QoL.
Background: Sexual dysfunction is a common side effect of medical therapy for benign prostatic hyperplasia (BPH), whereas prostatic urethral lift (PUL) offers safe and effective relief of lower urinary tract symptoms while preserving sexual function.
Objective: To compare the long-term impact on the sexual health of PUL or daily medical therapy of doxazosin or finasteride alone or in combination in BPH patients.
Design, setting, and participants: This was a comparative analysis of sexual function outcomes from PUL studies (L.I.F.T. [n = 107], Crossover [n = 42], and MedLift [n = 39]) and the Medical Therapy of Prostatic Symptoms (MTOPS) trial. The men included were sexually active with International Prostate Symptom Score 13, Qmax 12 ml/s, and prostate volume 30–80 cm3. MTOPS subjects completed the Brief Male Sexual Function Inventory, while PUL subjects completed the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function.
Outcome measurements and statistical analysis: Mean percentage changes from baseline in erectile, ejaculatory, and sexual satisfaction domains were compared at 12, 24, 36, and 48 mo.
Results and limitations: PUL significantly improved erectile function through 24 mo, and ejaculatory function and sexual satisfaction across all time points. Medical therapy did not improve sexual function at any time point. Finasteride significantly decreased erectile function at 48 mo, and combined therapy significantly reduced ejaculatory function at 12 and 24 mo. Comparatively, PUL was superior to finasteride in preserving erectile function at 24 and 48 mo and superior to doxazosin and combined therapy at 12 mo. PUL outperformed all three medical therapies at all time points in improving ejaculatory function and sexual satisfaction. Limitations include the use of distinct patient-reported questionnaires and narrowed data on comorbidities that influence male sexual function.
Conclusions: Indirect comparison reveals that PUL is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction.
Patient summary: In our non–head-to-head study, only patients undergoing PUL for an enlarged prostate experienced improvements in sexual health. Conversely, patients on medical therapy experienced worsening of erectile and ejaculatory function.
1. Introduction
Sexual activity is highly prevalent among aging men and is an important aspect of their quality of life (QoL) [1]. Consequently, common age-related conditions that affect male sexual activity, including erectile dysfunction (ED), ejaculatory dysfunction (EjD), and benign prostatic hyperplasia (BPH), may have overlapping patient populations who are enduring repercussions such as anxiety and depression resulting from diminished QoL [2,3].
The prevalence of BPH among men amounts to 50% at age 50 yr and is as high as 90% at 80 yr of age [4]. Of this population, approximately 50% are at high risk of developing age-related sexual dysfunction [5]. The association between lower urinary tract symptoms (LUTS) and sexual dysfunction has been consistently demonstrated in multiple epidemiological and clinical studies, and it has been found that LUTS is one of the strongest predictors of male sexual dysfunction [1,6]. From a clinical perspective, the impact of BPH interventions on male sexual function has become increasingly relevant, with the American Urological Association and European Association of Urology now recommending that patients be assessed and counseled about their sexual health before and after treatment [7,8].
Within the treatment space for LUTS/BPH, a blockers and 5a-reductase inhibitors (5-ARIs), either alone or in combination, have gained a stronghold as first-line therapy. Although they have demonstrated clinical efficacy, their use has been associated with sexual side effects, which vary in rate among different drug classes and between members in the same class [9,10]. For example, 5-ARIs have been associated with sexual adverse events such as ED, EjD, change in libido, and gynecomastia. Alpha-blockers have been linked to impaired ejaculation where the super-selective tamsulosin and silodosin have been associated with EjD, including lower ejaculate volume and anejaculation [9].
Conversely, the prostatic urethral lift (PUL) procedure using UroLift System implants is the only leading minimally invasive surgical therapy that offers rapid, significant, and durable symptom relief of LUTS without causing new sustained ED or EjD [11–15]. The safety profile, which consists of mild to moderate side effects that typically resolve by 2–4 wk, and effectiveness of PUL have been established in multiple clinical studies, as well as in the real-world setting in more than 1400 patients [11,12,14– 16]. Non–head-to-head comparisons have demonstrated a mean International Prostate Symptom Score (IPSS) reduction of 10.6–11.4 points at 12 mo after PUL, versus 3.5–7.5 points with medication [11,12,17].
In this comparative analysis examining the impact of PUL or medical therapy on male sexual health, we challenge the idea that medical therapy is the most conservative, minimally invasive treatment option for BPH patients. Erectile, ejaculatory, and sexual satisfaction outcomes for sexually active men from three separate PUL clinical studies are combined and compared to results from the Medical Therapy of Prostatic Symptoms (MTOPS) trial, one of the largest and longest trials to assess the effects of medication on BPH progression [18]
3. Results
3.1. Baseline demographics
3.2. Sexual function outcomes
3.3. Erectile function
3.4. Ejaculatory function
3.5. Sexual satisfaction
4. Discussion
4.1. a blockers
4.2. 5-ARIs
4.3. Combination therapy
4.4. PUL
5. Conclusions
The long-term effects on sexual health in BPH patients following treatment with PUL or once-daily medical therapy reveal that PUL provides a safe and effective alternative for men who are currently underserved by medical therapy and who wish to maintain and possibly improve sexual function, a key aspect of an individual’s health and QoL.
