A Systematic Review of the Optilume^® Drug-Coated Balloon in the Management of LUTS Secondary to BPH and Urethral Stricture

Abstract

Background and Objective: Benign prostatic hyperplasia (BPH) and urethral stricture (US) are common causes of lower urinary tract symptoms in ageing men, often requiring repeated interventions. Conventional treatments of US, such as urethrotomy and mechanical dilation, have high recurrence rates. The Optilume drug-coated balloon catheter system, which combines mechanical dilation with paclitaxel delivery, has emerged as a minimally invasive alternative. This systematic review assesses its efficacy and safety in the management of BPH and US. Methods: A systematic search of PubMed was conducted for studies published between August 2020 and October 2023. Eligible studies included randomised controlled trials (RCTs), cohort studies, and case reports evaluating Optilume’s therapeutic effects. Key outcomes analysed included symptom relief, urinary flow improvement, recurrence rates, and adverse events. Results: Seven studies met the inclusion criteria, including five on US and two on BPH. The ROBUST trial series demonstrated sustained improvements in urinary flow rates and symptom scores in US patients over follow-up periods of up to four years. The EVEREST-1 and PINNACLE trials reported significant symptom relief and preserved sexual function in BPH patients, with a favourable safety profile and minimal complications. Conclusions: Optilume appears to be a promising alternative to conventional endoscopic treatments for US and BPH, offering durable symptom relief with a low complication rate. Further long-term studies are required to confirm its efficacy and cost-effectiveness in routine clinical practice.

1. Introduction

Benign prostatic hyperplasia (BPH) and urethral stricture (US) are common causes of lower urinary tract obstruction in ageing men, often leading to significant impairment in quality of life (QoL) [1,2]. The severity of these conditions necessitates a precise diagnosis to guide patients towards the most suitable treatment options [3]. Conventional management includes endoscopic urethrotomy, urethral dilation, or urethroplasty in cases of complex or recurrent stenosis [3].

Endoscopic urethrotomy is widely regarded as the gold standard for treating male anterior urethral strictures; however, its failure rates range between 24% and 54% [4]. Urethral balloon dilation has emerged as a potentially less invasive alternative, offering a circumferential expansion effect that may reduce tissue damage and the subsequent formation of spongiofibrosis [5,6,7]. Some studies suggest comparable recurrence rates between balloon dilation and standard urethrotomy, with similar improvements in urinary symptoms and maximum urinary flow rates at one month post-procedure [8].

Urethroplasty remains the preferred option for long and complex strictures, providing durable outcomes but requiring highly specialised surgical expertise [3]; thus, there is a continuous demand for more efficacious conservative treatments.

The Optilume Catheter System (OCS-Urotronic, Inc., Plymouth, MN, USA) is a minimally invasive surgical treatment applied to both BPH and US with promising early data in clinical trials [9]. It is the first drug-coated balloon that combines urethral dilation with the circumferential topical delivery of paclitaxel, a toxoid antineoplastic agent that acts as a mitotic inhibitor, stopping new tissue growth and preventing fibrotic scarring [10].

In the 1990s, paclitaxel was first used as a chemotherapy drug [11], and in 1997, Di et al. published data on its effects on the proliferation and migration of human arterial smooth muscle cells (haSMCs) in vitro [12]. Its long-lasting effect after just a few minutes’ exposure time made this lipophilic substance a promising candidate for the local antiproliferative therapy of arterial restenosis [12]. In 2004, paclitaxel was introduced in percutaneous coronary interventions and has been extensively used in vascular devices to prevent restenosis after balloon angioplasty or stenting [13,14]. In 2011, Will et al. reported that paclitaxel effectively inhibited canine ureteral smooth muscle cell proliferation and collagen production without toxicity to smooth muscle cells [15].

The first study using a paclitaxel-coated balloon for US was published in 2020 by Elterman et al. [16]. The authors described Optilume treatment as an intermediate step before repeated dilations, urethrostomies, urethroplasty, or as an option for patients who are poor surgical candidates or decline urethroplasty. In 2020, the first clinical trial providing two-year outcomes on the efficacy of Optilume in men with moderate-to-severe LUTS secondary to BPH was published (EVEREST-1) [17]. In December 2021, the Food and Drug Administration (FDA) approved Optilume urethral drug-coated balloons for the treatment of anterior US of less than 2 cm. In June 2023, the Optilume BPH Catheter System was FDA-approved for BPH (

Table 1. FDA (Food and Drug Administration) approval.

FDA Approval (OCS)	No FDA Approval (OCS)
Obstructive urinary symptoms associated with BPH or with anterior urethral stricture	Meatal stenosis
Adult male (age 50 and older)	Neck stenosis
Previous surgery for urethral stricture	Posterior urethral stricture
Anterior urethral stricture of ≤3 cm in length.	Urethro-vesical anastomosis post RP

) [18].

This systematic review aims to synthesise current evidence on the role of Optilume in treating both BPH and US-related LUTS. Additionally, it analyses available comparative studies between Optilume and conventional approaches, including urethrotomy and mechanical dilatation, to assess its clinical advantages. (

Table 2. Comparative table of urethral stricture treatments *.

Optilume™ DCB	mechanical dilation+ paclitaxel	- Minimally invasive procedure. - Potentially reduces recurrence rates - Short catheterisation	- Long-term efficacy - 70% anatomical success rate at 12 months for short bulbar strictures.	Minimally	Short bulbar strictures (<2 cm) and BPH	~70% at 12 mo	Data emerging
Urethral Dilation	Gradual stretching of the urethra	- Simple and quick procedure. - Minimal equipment required.	High recurrence rates; - Risk of urethral trauma and false passages.	Minimally	Initial management of short strictures	Variable	High
DVIU	Endoscopic incision of the stricture to restore urethral patency	Minimally invasive with quick recovery.	- High recurrence rates - Not recommended for long or complex strictures	Minimally	Single, short bulbar strictures	~20% long-term	High
Urethroplasty	Surgical reconstruction using grafts/flaps.	- High long-term success rates (>85%). - Definitive treatment with low recurrence.	- Invasive procedure. - Longer recovery period.	Invasive	Long, recurrent, or complex strictures	>85%	Low

* The frequency and severity of adverse events in the Optilume studies were systematically assessed through the following: 1. Patient Monitoring: Patients were monitored at specified intervals post-procedure, including immediate post-operative periods and follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months. 2. Standardised Reporting: Adverse events were documented using standardised case report forms, ensuring consistency in data collection across study sites. 3. Severity Grading: The severity of each adverse event was graded using established classification systems, such as the Clavien–Dindo grading system, which provides a standardised method for categorising surgical complications based on the required level of intervention [https://www.centerwatch.com/clinical-trials/listings/NCT06312722/safety-and-effectiveness-of-the-optilumer, accessed on 1 July 2025].

)

2. Materials and Methods

2.1. Study Design

This study is a systematic review of peer-reviewed literature evaluating the clinical use of the Optilume Catheter System in the treatment of BPH and US. The review includes both experimental and clinical studies to provide a comprehensive overview of its effectiveness and safety profile.

We declare that we have drafted a systematic review in accordance with the PRISMA guidelines [19].

2.2. Search Strategy

A systematic search of PubMed was conducted for relevant studies published between August 2020 and October 2023. The search terms included “Optilume”, “Optilume and balloon”, “Optilume and BPH” and “Optilume and stricture and urethra”. Two independent reviewers screened the titles and abstracts of each citation. Additionally, reference lists of eligible articles were examined, and the “Related Citations” feature in PubMed was utilised to identify further relevant studies.

Eligibility Criteria Based on the PICOS Framework:

• Population: The study population consisted of male patients undergoing Optilume balloon dilation for anterior urethral strictures or BPO.
• Intervention: The placement of the Optilume drug-coated balloon.
• Comparison: Studies comparing Optilume with conventional treatments such as urethrotomy or mechanical dilation were included.
• Outcomes: The primary endpoint was the assessment of the efficacy of Optilume in treating BPO and US.
• Study Type: Randomised controlled trials (RCTs), cohort studies, and case reports evaluating the Optilume device were included. Reviews, commentaries, corrections, and updates were excluded. Only English-language studies were considered.

2.3. Data Extraction and Quality Assessment

Studies were assessed for their level of scientific evidence based on the Oxford Centre for Evidence-Based Medicine (March 2009) [20]. Data were extracted regarding study design, sample size, patient demographics, intervention details, clinical outcomes, and adverse events.

2.4. Device Description

The Optilume^® system (Plymouth, MN, USA)is a minimally invasive treatment combining mechanical dilation with localised paclitaxel delivery to address anterior urethral strictures and benign prostatic hyperplasia (BPH). The device features a drug-coated balloon designed to widen narrowed urethral segments while delivering paclitaxel to inhibit scar tissue formation, thereby reducing recurrence rates. For BPH treatment, the system employs a dual-balloon approach: an initial pre-dilation balloon followed by a drug-coated balloon to maintain urethral patency. Clinical studies, such as the Robust I and III trials, have demonstrated significant improvements in urinary flow rates and symptom scores, with sustained benefits observed over multiple years. The procedure is typically performed under general or spinal anaesthesia, with a Foley catheter placed post-operatively for 48–72 h. Patients are advised to use contraception for a period following treatment due to the presence of paclitaxel in bodily fluids [16,21,22,23]. (

Table 3. Studies on Optilume BPH.

Author	Title	Type of Study	Primary Outcome	FU/yr
Pichardo, August 2023	EVEREST-I Study [22]	RCT-open-label, single-arm	Functional improvement	2 yr
Kaplan, September 2023	PINNACLE Study [24]	RCT-prospective, randomised, double-blind	Functional improvement	1 yrs

)

The Optilume device consists of the following structural components (Figure 1):

• Inflatable balloon with a paclitaxel coating and a double-wall thickness
• Two marker bands at the ends of the balloon
• A distal end (bladder neck direction) and a proximal end (urethral meatus direction)
• Distal and proximal cone angles
• Atraumatic tapered tip [16]

Figure 1. Optilume Urethral Drug-Coated Balloon for Urethral Stricture. The figure was created by the author MD Colalillo Gaia.

Figure 1. Optilume Urethral Drug-Coated Balloon for Urethral Stricture. The figure was created by the author MD Colalillo Gaia.

The device incorporates a hydrophilic guide wire (0.038”) activated with saline solution. Lidocaine use post-procedure is discouraged as it may interfere with paclitaxel absorption [20].

For BPH treatment, the Optilume BPH Catheter System consists of two balloon catheters: a pre-dilation balloon initiating the anterior commissurotomy and a drug-coated balloon delivering paclitaxel to the prostatic urethra. The balloon size is determined based on ultrasound measurements of the prostate and prostatic urethra length.

2.5. Technical Aspects of the Procedure

The mechanical expansion of the balloon creates micro-fissures in the urethral mucosa, allowing gradual absorption of paclitaxel (>30 days). Due to its hydrophobic nature, paclitaxel does not undergo immediate washout. The controlled release mechanism ensures circumferential drug delivery, reducing the risk of overdose [20] (Figure 2).

The procedure is performed as day surgery under general or spinal anaesthesia. Post-procedure, a Foley catheter is inserted for 48–72 h. Paclitaxel may be present in the urine and semen for up to three months post-treatment, necessitating condom use during sexual activity for at least 30 days, and contraception for six months in cases of suspected pregnancy [20].

For anterior US treatment, the Optilume device has a single 30 Fr balloon with a length of approximately 30 mm and varying diameters (18.0/6.0 Fr/mm; 24.0/8.0 Fr/mm; 30.0/10.0 Fr/mm). Other balloons measuring 18, 24, and 36 Fr are available, with all diameters offered in lengths of 3 and 5 cm. The selected balloon should exceed the stricture length by at least 1 cm. In cases of stenosis > 2 cm, a balloon length of at least 5 cm is required [16].

Before balloon placement, the severity of stenosis is evaluated. Severe stenosis may necessitate mucosal incision to facilitate guide wire passage. The guide wire is advanced 1 cm beyond the stricture, ensuring optimal balloon alignment with the stenotic segment. For effective drug delivery, the drug-coated balloon must hydrate in the urethra for at least 60 s before inflation.

The inflation pressure varies according to balloon size:

• 18 and 24 Fr balloons: 12 ATM
• 30 Fr balloon: 10 ATM
• 36 Fr balloon: 8 ATM

Pressure must be maintained for at least 5 min to ensure effective drug transfer and tissue dilation. Insufflation should be performed with at least 20 cc of fluid, with a maximum gauge pressure of 15 ATM [16].

2.6. Ethical Considerations

This systematic review was conducted in accordance with ethical guidelines and did not require approval from an ethics committee, as it involved the analysis of anonymised data from previously published studies.

3. Results

A total of 16 manuscripts were initially identified. Figure 3 presents a PRISMA flowchart. Following the application of exclusion criteria, seven studies were deemed eligible for inclusion: five related to urethral stricture (US), including a single-blind randomised controlled trial (RCT), and two related to benign prostatic hyperplasia (BPH), comprising two prospective double-blinded RCTs. Only one case report described the use of the Optilume drug-coated balloon system (OCS) for the management of female US. Additionally, one study utilised a cohort Markov model to estimate the cost-effectiveness of Optilume versus standard endoscopic urethrotomy over a five-year follow-up period (Table 3 and Table 4). Side effects and adverse events were examined at multiple time points to capture both immediate and delayed complications. These time points included the following:

• Immediate Post-operative Period: Monitoring for acute complications such as bleeding, pain, or urinary retention.
• 1 Week Post-Procedure: Assessment of early recovery and identification of any emerging side effects.
• 1 Month Post-Procedure: Evaluation of short-term outcomes and resolution of initial side effects.
• 3, 6, and 12 Months Post-Procedure: Long-term follow-up to assess the durability of the treatment effect and identify any late-onset complications.

Figure 3. PRISMA Flow Diagram: phases of this systematic review. The figure was created by the author MD Colalillo Gaia.

Figure 3. PRISMA Flow Diagram: phases of this systematic review. The figure was created by the author MD Colalillo Gaia.

Table 4. Studies on Optilume US.

Author	Title	Type of Study	Primary Outcome	FU/yrs/mo
Delong, January 2022	Robust II [25]	RCT-single blind	Functional improvement	1 yr
Stuehmeier, March 2022	Optilume drug-coated balloon dilation in complex female urethral stricture [26]	Case report	Functional improvement in female	6 mo
Elliott, April 2022	Robust III study [21]	RCT-single-blind	Functional improvement	1 yr
Virasoro, May 2022	Robust I Study [25]	RCT-single blind	Functional improvement	3 yr
Kelly, April 2023	Economic evaluation of Optilume, a drug-coated balloon for recurrent anterior male urethral stricture [23]	Study of cohort	Cost-saving

Table 4. Studies on Optilume US.

Author	Title	Type of Study	Primary Outcome	FU/yrs/mo
Delong, January 2022	Robust II [25]	RCT-single blind	Functional improvement	1 yr
Stuehmeier, March 2022	Optilume drug-coated balloon dilation in complex female urethral stricture [26]	Case report	Functional improvement in female	6 mo
Elliott, April 2022	Robust III study [21]	RCT-single-blind	Functional improvement	1 yr
Virasoro, May 2022	Robust I Study [25]	RCT-single blind	Functional improvement	3 yr
Kelly, April 2023	Economic evaluation of Optilume, a drug-coated balloon for recurrent anterior male urethral stricture [23]	Study of cohort	Cost-saving

Although the included studies did not adopt standardised eligibility criteria for either condition, patients treated with OCS commonly presented with a history of failed prior endoscopic interventions [21,22].

3.1. Primary Results

3.1.1. Benign Prostatic Hyperplasia (BPH)

The EVEREST-1 trial, a prospective, single-arm, non-randomised, open-label, multi-centre study, was the first to assess the one-year clinical outcomes of Optilume BPH. The study enrolled 80 men with a prostate volume of 20–80 cc and an International Prostate Symptom Score (IPSS) of ≥13. Pain intensity following the procedure was low, with Visual Analogue Scale (VAS) scores averaging 0.8  ±  1.5 at baseline, 1.7  ±  2.3 immediately post-procedure, 1.8  ±  2.1 at Foley catheter removal, and 1.0  ±  2.0 at 30 days. At three months, 40% of patients demonstrated symptomatic improvement (measured by IPSS), with more than half maintaining benefits for up to a year. The average peak urinary flow rate (Qmax) increased from 10.9  mL/s at baseline to 20.5  mL/s at three months, 19.6  mL/s at six months, and 18.4  mL/s at one year. Ejaculatory function, as assessed by the Male Sexual Health Questionnaire Ejaculatory Dysfunction (MSHQ-EjD) domain, was preserved, and the International Index of Erectile Function (IIEF) scores remained stable, with slight improvements noted at one year.

The most commonly reported treatment-related adverse events included haematuria (15.0%), post-operative urinary retention (13.8%), urinary incontinence (13.8%), urinary tract infection (8.8%), ejaculatory dysfunction (8.8%), and dysuria (7.5%) [23,24].

Clinical studies, including the Pinnacle trial, primarily enrolled patients with prostate volumes ranging from 20 to 80 g. Consequently, the safety and efficacy of the Optilume BPH system in patients with prostates exceeding 80 mL remain less well-defined. Further research is necessary to ascertain outcomes in this subgroup [24].

The OCS has also been evaluated for urethral strictures. In the Robust I study, patients with a history of prior endoscopic treatments showed promising results, with significant improvements in urinary flow rates and symptom scores sustained over five years. Notably, no serious treatment-related adverse events were reported, and sexual function was preserved.

The use of larger-diameter balloons in the Optilume procedure has been associated with a higher incidence of adverse events, including increased rates of bleeding and urinary incontinence. These findings led to the discontinuation of the largest balloon sizes in subsequent study cohorts [25].

Regarding interest in patients with prostates larger than 80 mL, it is important to note that the Pinnacle study included men with prostate volumes between 20 and 80 g [24]. Therefore, data on patients with larger prostates are limited. Similarly, while the Robust III trial for anterior urethral strictures included patients with an average of 3.2 prior endoscopic interventions, the study focused on strictures averaging 1.63 cm in length [25]. Information on the use of larger balloons and their associated outcomes would require further investigation.

For a comprehensive understanding of the safety and efficacy of the Optilume system in these specific patient populations, additional studies focusing on larger prostate volumes, previously treated urethral strictures, and the use of larger balloons would be beneficial.

In the Pinnacle study, 100 patients underwent Optilume BPH treatment, while 48 were assigned to the sham procedure. The average procedure time was longer in the Optilume group (26 min) compared to the sham group (8 min). However, the catheterisation duration was similar in both cohorts. At 12 months, the average IPSS improvement was significantly greater in the Optilume group (11.7 points) compared to the sham group (7.8 points). Qmax improvements at 12 months were also superior in the Optilume cohort (+9.7  ±  10.1 vs. +5.5  ±  7.4 mL/s, p = 0.009). Post-void residual (PVR) volume declined from 82 mL at baseline to 58 mL at one year.

Non-serious adverse events in the Optilume BPH cohort included haematuria (39/98), urinary tract infections (14/98), dysuria (9/98), urge/mixed incontinence (8/98), mild stress incontinence (7/98), bladder spasms (6/98), elevated prostate-specific antigen (PSA) levels (6/98), and urinary urgency (6/98). Sexual function remained largely unaffected, with four patients in the Optilume group and one in the sham group reporting ejaculatory dysfunction (4/98 vs. 1/48). No treatment-related de novo erectile dysfunction was observed [25].

Neither the EVEREST-1 nor Pinnacle studies reported procedural duration, recurrence rates, or cost-related data.

3.1.2. Urethral Stricture (US)

The efficacy of OCS for recurrent anterior US was investigated in three trials: Robust I, II, and III.

• Robust I established anatomical success as the ability to pass a 16 Fr flexible cystoscope or a 14 Fr Foley catheter. While cystoscopy was not performed beyond one year, functional success—defined as a ≥50% IPSS improvement without retreatment—was achieved in 70% of patients (32/46) at two years.
• Robust II confirmed the safety profile of Optilume, demonstrating sustained anatomical and symptomatic improvements at six months and one year.
• Robust III, a randomised controlled trial, reported one-year outcomes. The average time for drug-coated balloon (DCB) insertion and removal was 8 min and 42 s. At six months, anatomical success was significantly higher in the OCS group than in the control group (74.6% vs. 26.8%). The one-year recurrence-free rate also favoured OCS. Qmax initially improved in both groups, but while control patients exhibited deterioration after three months, the OCS cohort maintained a nearly twofold increase at one year. PVR levels remained higher in the control group at six months and one year compared to baseline.

Mild post-procedural haematuria was more frequent in the OCS group; however, these events resolved within 30 days in 10 of 11 cases. No changes in sexual function, as assessed by IIEF scores, were observed in either cohort. Drug concentrations in urine were highest immediately post-procedure but declined to below quantifiable limits by 30 days. In Robust III, paclitaxel levels in semen were minimal and undetectable after three months [2].

3.2. Secondary Results

While most patients demonstrated significant symptomatic improvement following Optilume treatment, a subset required additional intervention. In the Robust III trial, one patient exhibited incomplete response and underwent secondary treatment. Furthermore, no serious adverse effects related to OCS were reported in the BPH or US cohorts, and all participants who achieved initial symptomatic improvement maintained stable outcomes during follow-up.

Table 5. Optilume™ BPH/US DCB Dilation Catheter: adverse events (not serious) in the short term.

Study Optilume BPH/US	Urinary Tract Infection	Haematuria	Urinary Retention	Urinary Incontinence	Dysuria	Ejaculation Disorder	Bladder Spasms	Urinary Urgency
EVEREST-1 (Tot. patients n. 80) [22]	7	11	8	5	6	7	-	-
PINNACLE (Tot. patients n. 98) [24]	14	39		7	9	4	6	6
Robust III (tot. Patients n. 98) [20]	1	11	-	-	2	0	-	-
Robust II (tot. Patients n. 16) [25]	4	1	1	-	-	0	1	2
Robust I (tot. Patients n. 35) [25]	1	1	1	1	1	0	-	1

provides a summary of reported complications across the included studies.

4. Discussion

The available clinical data indicate that men with recurrent urethral stricture (US) who had previously failed multiple standard endoscopic treatments remained stricture-free for at least two years following treatment with the Optilume drug-coated balloon system (OCS), with a significant improvement in urinary function [9]. The results demonstrated a 250% increase in urinary flow and a 73% reduction in symptoms, including urinary frequency, incomplete bladder emptying, weak stream, straining, and nocturia [27].

Several potential advantages of the Optilume BPH/US approach over standard endoscopic treatments have been suggested. The combination of mechanical dilation with drug release offers an alternative for patients with US and an option for those with benign prostatic hyperplasia (BPH) who are poor surgical candidates or decline standard treatment due to concerns about sexual dysfunction. Additionally, the short catheterisation time, low rates of intra- and post-operative complications, immediate patient satisfaction, and mid-term improvement in obstructive urinary symptoms contribute to the appeal of this technique. The rapid elimination of the drug in urine and semen, with no evidence of long-term teratogenic effects, further supports its safety. The procedure itself is technically straightforward and appears to offer a cost-effective alternative due to its potential to reduce US recurrence rates [13].

A primary limitation of standard endoscopic techniques for BPH is the high incidence of retrograde ejaculation [17]. Like other ejaculation-sparing approaches, such as Rezūm, Aquablation, and UroLift, one of the key advantages of the Optilume procedure is its preservation of both erectile and ejaculatory function [28].

Current literature on the use of OCS for BPH treatment primarily consists of randomised controlled trials (RCTs) with short- to mid-term follow-up. The PINNACLE trial has completed enrolment, evaluating approximately 100 out of 148 patients treated with Optilume BPH, with benefits observed for up to one year [25]. The EVEREST-I study demonstrated a rapid improvement in lower urinary tract symptom (LUTS) severity and voiding function within two weeks, which persisted through one year, comparable to results seen with emerging technologies such as Rezŭm and UroLift [22,23,28].

Regarding the efficacy of OCS in US, the European Association of Urology (EAU) guidelines provide a weak recommendation for offering Optilume in patients with short (<3 cm) bulbar strictures recurring after at least two prior endoscopic treatments, provided urethroplasty is not an option [3] (Table 2).

When compared to other minimally invasive procedures like Rezūm and UroLift, Optilume offers distinct advantages and considerations in terms of postprocedural complications, catheterisation requirements, ejaculation preservation, and cost-effectiveness [24].

Optilume has demonstrated a favourable safety profile. In the Pinnacle study, the most common adverse events were haematuria (39.8%) and urinary tract infections (11.2%), with most events being mild or moderate in severity and resolving within 34 days [24]. Notably, no device- or treatment-related serious adverse events were reported beyond 12 months post-procedure. Post-procedure catheterisation duration varies among these treatments. Optilume patients typically require Foley catheter placement for 48–72 h. Preservation of sexual function is a significant consideration in BPH treatments. Optilume has shown no significant impact on sexual function, with International Index of Erectile Function (IIEF) scores improving over a two-year period [24].

Rezum therapy, which utilises water vapor thermal energy to ablate prostatic tissue, has been associated with acute urinary retention rates ranging from 11% to 32%, and other complications such as haematuria and dysuria. Rezum therapy has a low incidence (~2%) of ejaculatory dysfunction, with erectile function generally preserved.

These adverse events are generally transient but may extend the recovery period. Rezum patients often need catheterisation for an average of 4 days due to post-procedural swelling [28].

UroLift, employing mechanical retraction of prostatic lobes, tends to have a milder complication profile, with common side effects including haematuria, dysuria, and pelvic discomfort, typically resolving within two weeks. UroLift patients have the shortest catheterisation duration, with approximately 30–35% requiring catheterisation for a mean duration of 0.9 days. UroLift stands out with no reported cases of ejaculatory dysfunction and preserved erectile function [29].

Cost-effectiveness is an important factor in treatment selection. While specific cost data for Optilume are limited, it is considered a cost-effective alternative to more invasive surgical options [30]. Rezum therapy has demonstrated cost-effectiveness, achieving cost equivalence with combination medical therapy in less than two years.

UroLift, although having higher upfront costs compared to transurethral resection of the prostate (TURP), offers benefits in terms of shorter recovery times and preservation of sexual function [31].

The Robust clinical trial series (Robust I, II, and III) demonstrated significant improvements in symptomatic and functional outcomes for urethral strictures (<3 cm) over four years. Robust I, the first human trial, showed a 176% increase in Qmax (baseline: 5.1 mL/s; three-year: 14.1 mL/s) and a 65% decrease in IPSS (baseline: 25.2; three-year: 8.8), with durability of 77% over three years. Robust II confirmed the safety of the device with one-year follow-up results, while Robust III, a pivotal RCT, reported an 83% reintervention-free rate at 12 months compared to 22% in the standard treatment arm [21,26]. The most common adverse events included urinary tract infection, post-procedural haematuria, and dysuria, with minimal analgesic use limited to the day of surgery and the first post-operative day.

The only reported application of Optilume in female US involved a 50-year-old patient with a 1.8 cm fibrotic stricture involving the sphincteric urethra due to multiple prior urethral surgeries. Treatment was successful in the short term, with a follow-up of six months, and no evidence of sphincter damage [32].

A cost analysis conducted in England compared Optilume dilation to standard endoscopic techniques and demonstrated an estimated cost saving of GBP 2502 per patient. Compared to urethroplasty, Optilume resulted in cost savings of approximately GBP 243 per person, mainly due to a reduction in recurrence rates [33].

A key strength of this review is its comprehensive analysis of the existing evidence regarding Optilume for both US and BPH, providing insights into its efficacy, safety, and potential cost-effectiveness. The findings suggest that Optilume represents a promising alternative to conventional endoscopic treatments, particularly for patients prioritising the preservation of sexual function and those seeking minimally invasive options with durable outcomes.

However, this study has several limitations. Firstly, as a narrative review, it is subject to inherent biases in study selection and data interpretation. The paucity of long-term follow-up data limits the ability to assess the durability of treatment benefits beyond the timeframes reported in existing trials. Additionally, due to the heterogeneity in study designs and outcome measures, a meta-analysis and data pooling were not feasible. Future research should aim to establish standardised eligibility criteria to refine patient selection and optimise treatment outcomes [34].

In the Pinnacle, the Optilume group showed an average Qmax improvement from 8.9 mL/s at baseline to 19.0 mL/s at 1 year, representing a 113% increase. These improvements were sustained through 2 years, with 67.5% of participants achieving a ≥30% improvement in IPSS without additional therapy [24]. In the Everest study, average Qmax improvement was +5.6 mL/s from baseline, and no late-onset device complications or adverse effects on sexual function were observed [22]. The safety profile of Optilume BPH is favourable, with most adverse events occurring within the first three months post-procedure. Common events included haematuria (15%) and urinary retention (13.8%). Importantly, no significant impact on sexual function, including erectile and ejaculatory function, was reported through long-term follow-up [22].

Compared to other MISTs like UroLift and Rezūm, OCS-BPH demonstrates a more rapid and sustained improvement in LUTS. For instance, in the Everest-I study, the IPSS improved from 22.3 at baseline to 7.9 at 1 year, a reduction of 14.4 points. In contrast, UroLift and Rezūm reported reductions of approximately 11.1 and 10.2 points, respectively, over similar periods [29].

The OCS-BPH offers a promising alternative for patients seeking minimally invasive treatment for BPH-related LUTS. Its combination of mechanical dilation and localised drug delivery provides rapid symptom relief with sustained efficacy and a favourable safety profile. While direct comparisons with other MISTs suggest superior outcomes, further head-to-head studies are warranted to establish its position in the therapeutic landscape.

5. Conclusions

The current evidence suggests that Optilume represents a promising alternative for the treatment of both recurrent US and BPH, offering significant symptom relief, improved urinary function, and potential cost savings compared to standard endoscopic approaches. Unlike conventional treatments, Optilume appears to preserve erectile and ejaculatory function, which is a key consideration for many patients.

While preliminary results are encouraging, further studies with long-term follow-up and larger cohorts are needed to confirm the durability of treatment effects and refine patient selection criteria. Clinicians should consider Optilume as a viable option for select patients, particularly those who have failed multiple endoscopic treatments or are seeking minimally invasive alternatives. Ongoing and future trials will provide further clarity on its role in clinical practice and its long-term cost-effectiveness [35].