Single-Surgeon, Single-Centre Experience with Three-Piece Inflatable Penile Prosthesis Implantation in Dubai (Natheer Study): A Prospective Cohort of 69 Consecutive Cases with Detailed Surgical Protocol and Functional Outcomes
- 1. Department of Urology and Andrology, United Arab Emirates
Abstract
Background and Objective: Penile prosthesis implantation (PPI) is the gold-standard treatment for medication-refractory erectile dysfunction (ED). Outcomes are highly surgeon-dependent, yet no published series has described a protocol in which a single surgeon performs every procedural step — from patient preparation and antisepsis through to post-operative activation — without any surgical assistant. We describe this novel protocol and report prospective outcomes for 69 consecutive cases in Dubai, UAE.
Methods: Prospective observational cohort study of 69 consecutive patients undergoing three-piece inflatable PPI by a single surgeon at a single center (March 2025 – March 2026). All patients underwent standardized preoperative ultrasound assessment and penile Doppler with intracavernosal injection. The surgeon personally performed all antisepsis steps, device preparation, and post-operative wound care.
Results: Mean age was 54.7 ± 14.3 years. Diabetes mellitus 60.9%, hypertension 52.2%, coronary artery disease 39.1%, and antiplatelet therapy at surgery 47.8%. Vasculogenic aetiology accounted for 55.1% of cases. Mean operative time was 119.0 ± 30.0 minutes. Infection rate 4.3% (n=3; all primary cases, all managed conservatively with daily wound dressing and extended antibiotic therapy — no revision surgery required); mechanical failure 0.0%; erosion 0.0%; corporal perforation 2.9% (n=2; all managed intraoperatively); revision surgery 0.0%. Mean patient satisfaction 9.68 ± 0.65/10; partner satisfaction 9.19 ± 0.96/10 (n=63). Mean time to first use 4.4 ± 1.2 weeks.
Conclusion: A rigorously standardized single-surgeon PPI protocol — incorporating comprehensive preoperative workup, sequential dual-agent antisepsis, pre-corporotomy reservoir placement, and structured post-operative surveillance — achieves complication rates consistent with international benchmarks and exceptional patient satisfaction in a high-comorbidity population.
Keywords
• Penile Prosthesis • Erectile Dysfunction • Single-Surgeon • Surgical Technique • Infection Prevention
Citation
Altopajee KN (2026) Single-Surgeon, Single-Centre Experience with Three-Piece Inflatable Penile Prosthesis Implantation in Dubai (Natheer Study): A Prospective Cohort of 69 Consecutive Cases with Detailed Surgical Protocol and Functional Outcomes. JSM Sexual Med 10(2): 1180.
ABBREVIATIONS
PPI: Penile Prosthesis Implantation; ED: Erectile Dysfunction; ICI: Intracavernosal Injection; PDE5i: Phosphodiesterase Type-5 Inhibitor; PSV: Peak Systolic Velocity; EDV: End-Diastolic Velocity; RI: Resistive Index; CAD: Coronary Artery Disease; DM: Diabetes Mellitus; GCC: Gulf Cooperation Council; IIEF: International Index of Erectile Function; GA: General Anesthesia; UAE: United Arab Emirates; CRP: C - reactive protein
INTRODUCTION
Erectile dysfunction (ED) affects an estimated 150-300 million men worldwide, with prevalence rising steeply with age and metabolic comorbidity [1]. The Gulf Cooperation Council (GCC) region presents a particularly challenging ED landscape: rates of type 2 diabetes mellitus, hypertension, dyslipidemia, and obesity rank among the highest globally, translating into a disproportionately high burden of vasculogenic and mixed-aetiology ED [2,3]. When phosphodiesterase type-5 (PDE5) inhibitor therapy, intracavernosal injection (ICI), and vacuum erection devices fail to restore satisfactory erectile function, three-piece inflatable penile prosthesis implantation (PPI) represents the definitive, evidence-based surgical intervention [4,5].
Modern three-piece inflatable prostheses from established manufacturers — Boston Scientific, Coloplast, ZSI, and Rigicon — offer five-year mechanical survival rates exceeding 90–95% in large registry studies [6,7]. Despite this technological maturity, reported outcomes across centers remain heterogeneous: infection rates range from under 1% in high-volume centers using antibiotic-impregnated devices to over 10% in series with suboptimal antisepsis protocols [8,9], corporal perforation rates of 1–5% and revision surgery rates of 5–15% have been reported in published series [10]. This variability underscores that outcome determinants are predominantly surgeon-related rather than device-related — encompassing surgical technique, infection-prevention strategy, patient selection, and perioperative management [11].
The individual surgeon’s expertise has been shown to be a primary driver of complication rates. Henry et al., demonstrated a strong inverse relationship between annual surgeon volume and infection risk [12]. Mulcahy emphasized that the delegation of technical tasks — shaving, scrubbing, and device preparation — to less experienced or less vigilant assistants introduces underappreciated contamination vectors [13]. Despite these observations, no published series has systematically eliminated task delegation by having a single surgeon personally perform every procedural step from patient preparation to post-operative activation.
Dubai represents a unique clinical milieu: a high-income city hosting a diverse, highly international population with a high prevalence of metabolic disease and a rapidly expanding demand for advanced urological surgery. There are currently no published prospective PPI series from the UAE or the broader GCC region. This study addresses that gap, presenting the first prospective, consecutive case, single-surgeon PPI cohort from Dubai. The primary-objectives are: (1) to describe the complete surgical protocol in sufficient detail to serve as a reproducible reference; and (2) to report patient characteristics, operative data, complication rates, and functional outcomes in context with published international benchmarks.
MATERIALS AND METHODS
Study Design and Ethics
This is a prospective, consecutive-case, single-surgeon, single-center observational cohort study conducted between March 2025 and March 2026 at a urological center in Dubai, UAE. All patients provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki. Data were collected prospectively and stored in a secure, anonymized institutional database in accordance with UAE Federal Law No. 2 of 2019 on the use of information and communication technology in health fields. No external funding was received.
Patient Selection and Inclusion Criteria
All adult male patients who underwent three-piece inflatable PPI by a single surgeon (KAA) during the study period were included consecutively. Inclusion criteria: (1) confirmed organic or mixed-aetiology ED refractory to maximum-dose PDE5 inhibitor therapy and/or ICI; (2) satisfactory optimization of cardiovascular, metabolic, and respiratory comorbidities as confirmed by specialist review; (3) valid written informed consent. There were no disease-severity exclusion criteria; patients with severe comorbidities, prior pelvic or penile surgery, and redo implantation were included provided anesthetic risk was deemed acceptable.
Preoperative Evaluation Protocol
Every patient underwent a comprehensive preoperative evaluation conducted entirely by the operating surgeon (KAA), including:
• Complete medical and sexual history: duration and severity of ED, prior treatments, cardiovascular history, medication review, and previous pelvic or penile surgical history
• Focused physical examination: penile, scrotal, and inguinal assessment; measurement of stretched penile length;
• Renal, bladder, and prostate ultrasonography: transabdominal pre- and post-void ultrasound with prostate volume calculation, post-void residual measurement, and bilateral inguinal orifice assessment for hernia
• Penile Doppler pharmacological ultrasonography erection: with standardized intracavernosal injection with a vasoactive agent; measurement of peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) in both cavernosal arteries — enabling physiological aetiology classification and documentation of cavernosal anatomy
• Multidisciplinary preoperative clearance: anesthetic assessment for all; cardiology review for CAD/coronary stent patients; endocrinology input for HbA1c > 8.0% or insulin-dependent diabetes; pulmonology review for significant respiratory comorbidity
Patients with active urinary tract infection, uncontrolled HbA1c above 10.0%, or acute coronary event within the prior three months were deferred until clinical optimization was achieved.
Surgical Protocol
Pre-theatre preparation: Patients received detailed written instructions to shower with 4% chlorhexidine gluconate solution on the night before and the morning of surgery. Intravenous antibiotics (cefazolin 2 g, or vancomycin 1 g in penicillin-allergic patients) were administered within 60 minutes of incision.
Theatre antisepsis — entirely surgeon-performed: A defining principle of this protocol is that the operating surgeon personally performed every antisepsis step without delegation to nursing or auxiliary personnel. The sequence was: (1) patient positioned supine with 15-degree Trendelenburg tilt; (2) surgical shaving of pubic, scrotal, and perineal regions performed by the surgeon using a sterile disposable razor; (3) chlorhexidine gluconate 4% solution applied and scrubbed vigorously by the surgeon for a minimum of five minutes, with particular attention to the glans penis, coronal sulcus, prepuce, and urethral meatus; (4) sequential betadine (povidone-iodine 10%) scrub applied and allowed to air-dry; (5) Foley urethral catheter (14 Fr) inserted by the surgeon under sterile technique; (6) mandatory complete glove change by the surgeon before any incision or device handling.
Operative technique: A penoscrotal transverse incision was used in all cases. A Wilson retractor was placed selectively (42.0% of cases), primarily when a newly scrubbed nurse was assisting or when morbid obesity limited penoscrotal exposure. The corpora cavernosa were identified bilaterally. Stay sutures (2-0 VIC) were placed at the proposed corporotomy sites on both sides, maintaining a minimum 9 cm from the coronal sulcus distally to allow adequate cylinder tip placement.
Pre-corporotomy reservoir placement: A key technical feature of this protocol is that the reservoir is placed before the corporotomies are made — when the field is completely bloodless. The intrapelvic space was accessed through the same incision in 94.2% of cases. This eliminates reservoir contamination by cavernosal blood and simplifies tubing length assessment.
Corporotomy and dilation: The cavernosa were opened longitudinally with a No. 15 blade — corporotomy length was kept to no more than 2 cm at each stay suture site to minimize tissue trauma and hemorrhage. Sequential dilation was performed bilaterally to a uniform maximum of 14. A technically important refinement in this protocol: after dilation to size 12, the contralateral dilator is temporarily placed in the dilated corpus whilst the ipsilateral side is advanced to size 13 and 14. This cross dilator technique maintains each corporal cavity open, prevents collapse, and facilitates symmetric sequential dilation. Copious antibiotic irrigation was performed (vancomycin 1 g + gentamicin 800 mg in 500 ml normal saline; modified for allergy). Digital and visual inspection confirmed absence of proximal, distal, or crossover perforation before cylinder sizing.
Cylinder sizing and implantation: Cylinders were sized using a Furlow insertion tool. Distal-first insertion was employed in 60.9% of cases and proximal-first in 39.1%, guided by intraoperative corporal anatomy; proximal first insertion was also selected when intraoperative perforation or crossover had occurred and required controlled cylinder seating. Mean bilateral cylinder length was 21.0 ± 2.3 cm. The surgeon changed gloves a second time before handling the prosthesis components.
Device preparation and handling: The prosthesis was opened by the surgeon personally on a separate back-table. Device handling was restricted exclusively to the surgeon’s hands — no nursing or assistant contact with the implant components. Antibiotic soaking was performed as per manufacturer guidance.
Connection testing and quality assurance: Quality was confirmed by: (1) firm lateral traction applied to each connection tube; (2) three complete inflation-deflation cycles confirming cylinder symmetry, girth, and rigidity; and (3) visual and manual confirmation of cylinder tips at the glans level. Corporotomies were closed with 2-0 VIC running locking suture. The wound was closed in layers (Dartos fascia: 2-0 Vicryl; skin: 3-0 Vicryl Rapide). Compressive sterile dressing applied. Foley catheter removed on post-operative day one.
Post-Operative Follow-Up Protocol
All wound care and follow-up visits were conducted by the operating surgeon:
• 48 hours: first dressing change; wound inspection; antibiotic review
• 1 week: second dressing change; wound assessment; suture inspection
• 2 weeks: critical infection surveillance visit — the most important post-operative appointment. Any erythema, warmth, or swelling was assessed by wound swab with leucocyte count and CRP and treated proactively. Patients were counselled on infection signs.
• 3 weeks: device activation — pump mechanism demonstrated; patient coached in inflation and deflation technique
• 4 weeks: first permitted sexual activity; functional assessment; patient satisfaction recorded
• Ongoing: as clinically indicated; formal outcome data collected at each visit
Outcome Measures
Primary outcomes: (1) intraoperative complication rate; (2) post-operative infection rate; (3) mechanical failure rate; (4) revision surgery rate. Secondary outcomes: patient satisfaction (0–10 Likert scale), partner satisfaction (0–10), and time to first device use (weeks).
Statistical Analysis
Descriptive statistics throughout. Continuous variables: mean ± SD with range. Categorical variables: n and percentage. Analysis performed in Microsoft Excel with verified database entries. No inferential statistics were planned for this descriptive cohort study.
RESULTS AND DISCUSSION
Patient Demographics and Comorbidities
Sixty-nine consecutive patients underwent PPI during the study period (March 2025 – March 2026). Mean age was 54.7 ± 14.3 years (range 25–85). The cohort demonstrated a substantial comorbidity burden: diabetes mellitus 60.9%, hypertension 52.2%, coronary artery disease 39.1%, coronary stent 33.3%, and smoking 27.5%. Of particular note, 47.8% of patients were receiving antiplatelet therapy — including aspirin, clopidogrel, ticagrelor, or warfarin — at the time of surgery. In this series, antiplatelet use did not result in significant intraoperative hemorrhage; minor subcutaneous discoloration was occasionally observed post-operatively but resolved spontaneously without intervention. The primary–redo distribution was 64 primary (92.8%) and 5 redo (7.2%) cases. Full demographic and comorbidity data are presented in Table 1.
Table 1: Patient Demographics, Comorbidities, and Aetiology in 69 Consecutive Penile Prosthesis Implantation Cases
|
Variable |
Value |
n |
|
Demographics |
|
|
|
Total patients |
69 |
69 |
|
Mean age (years) |
54.7 ± 14.3 (range 25–85) |
69 |
|
Median age (years) |
56 |
69 |
|
Age ≥ 60 years |
37 (53.6%) |
69 |
|
Comorbidities |
|
|
|
Diabetes mellitus |
42 (60.9%) |
69 |
|
Hypertension |
36 (52.2%) |
69 |
|
Coronary artery disease |
27 (39.1%) |
69 |
|
Coronary stent |
23 (33.3%) |
69 |
|
Smoking |
19 (27.5%) |
69 |
|
Antiplatelet therapy at surgery |
33 (47.8%) |
69 |
|
COPD |
1 (1.4%) |
69 |
|
ED Aetiology |
|
|
|
Vasculogenic (arterial/venous) |
38 (55.1%) |
69 |
|
Mixed/Other |
18 (26.1%) |
69 |
|
Endocrine |
5 (7.2%) |
69 |
|
Cavernous fibrosis / Peyronie's |
4 (5.8%) |
69 |
|
Previous prosthesis (redo etiology) |
2 (2.9%) |
69 |
|
Iatrogenic |
1 (1.4%) |
69 |
|
Neurogenic |
1 (1.4%) |
69 |
|
Primary vs Redo |
|
|
|
Primary implantation |
64 (92.8%) |
69 |
|
Redo implantation |
5 (7.2%) |
69 |
Abbreviations: CAD: Coronary Artery Disease; DM: Diabetes Mellitus; ED: Erectile Dysfunction; COPD: Chronic Obstructive Pulmonary Disease
ED Aetiology
Vasculogenic aetiology (arterial, venous, or combined) was the most common underlying cause, accounting for 55.1% of cases (n=38). Mixed or other aetiologies represented 26.1% (n=18), followed by endocrine (7.2%, n=5), cavernous fibrosis or Peyronie’s disease (5.8%, n=4), previous prosthesis (2.9%, n=2), iatrogenic (1.4%, n=1), and neurogenic (1.4%, n=1). All patients underwent preoperative penile Doppler with intracavernosal injection to document hemodynamic aetiology.
Surgical Technique and Operative Data
All 69 procedures were performed under general anesthesia. A Wilson retractor was employed in 29 cases (42.0%), primarily when a newly scrubbed nurse was assisting or when morbid obesity limited penoscrotal exposure. Cylinder insertion was distal-first in 60.9% (n=42) and proximal-first in 39.1% (n=27), guided by intraoperative corporal anatomy; proximal-first insertion was also selected when intraoperative perforation or crossover had occurred. The reservoir was placed intrapelvically via the same penoscrotal incision in 94.2% (n=65) of cases. Mean bilateral cylinder length was 21.0 ± 2.3 cm. Device brands used were Rigicon (58.0%), ZSI (18.8%), Boston Scientific (15.9%), and Coloplast (7.2%). Surgical technique details are summarized in Table 2.
Table 2: Surgical Technique Variables in 69 Consecutive Penile Prosthesis Implantation Cases
|
Surgical Variable |
n (%) |
Total n |
|
Anaesthesia |
|
|
|
General anesthesia |
69 (100%) |
69 |
|
Cylinder Insertion |
|
|
|
Distal-first insertion |
42 (60.9%) |
69 |
|
Proximal-first insertion |
27 (39.1%) |
69 |
|
Reservoir Placement |
|
|
|
Intrapelvic (same penoscrotal incision) |
65 (94.2%) |
69 |
|
Subcutaneous / ectopic |
4 (5.8%) |
69 |
|
Additional Elements |
|
|
|
Wilson retractor used |
29 (42.0%) |
69 |
|
Device Brand |
|
|
|
Rigicon |
40 (58.0%) |
69 |
|
ZSI |
13 (18.8%) |
69 |
|
Boston Scientific |
11 (15.9%) |
69 |
|
Coloplast |
5 (7.2%) |
69 |
|
Operative Data |
|
|
|
Mean bilateral cylinder length (cm) |
21.0 ± 2.3 |
69 |
|
Mean operative time (min) |
119.0 ± 30.0 (range 65–190) |
69 |
Abbreviations: GA: General Anesthesia
Complications
Corporal perforation occurred in 2 cases (2.9%): one proximal and one distal perforation, both detected by the systematic intraoperative perforation check and managed without device abandonment. No crossover perforations or significant intraoperative hemorrhage were recorded.
Post-operative infection was identified in 3 patients (4.3%). All three infections occurred in primary implantation cases — none in the five redo patients. Two of the three infections were identified at the mandatory two-week post-operative surveillance visit, enabling early intervention before deep implant infection was established. Critically, all three infected patients were managed successfully with a conservative approach: daily wound dressing and an extended course of targeted antibiotic therapy. The prosthesis was retained in all three cases and no revision surgery was required, yielding a revision surgery rate of 0.0%. No mechanical failures, erosions, or hematoma/seroma events were recorded. Complication data are detailed in Table 3.
Table 3: Intraoperative and Post-Operative Complications
|
Complication |
n (%) |
Notes |
|
Intraoperative |
|
|
|
Corporal perforation (any) |
2 (2.9%) |
All managed intraoperatively; no device abandonment |
|
— Proximal perforation |
1 (1.4%) |
Re dilation and reinsertion |
|
— Distal perforation |
1 (1.4%) |
Re sizing contralateral side |
|
— Crossover perforation |
0 (0.0%) |
— |
|
Significant intraoperative bleeding |
0 (0.0%) |
— |
|
Post-operative |
|
|
|
Infection |
3 (4.3%) |
All primary cases; 2 identified at 2-week surveillance visit; all managed conservatively with daily wound dressing and extended antibiotic therapy — prostheses retained in all cases |
|
Mechanical failure |
0 (0.0%) |
— |
|
Erosion |
0 (0.0%) |
— |
|
Hematoma / Seroma |
0 (0.0%) |
— |
|
Revision surgery |
0 (0.0%) |
No revision surgery required |
Abbreviations: All perforations detected intraoperatively and managed without device abandonment. All infections occurred in primary cases and were managed conservatively with daily wound dressing and extended antibiotic therapy; the prosthesis was retained in all cases and no revision surgery was required.
The 4.3% infection rate warrants contextualization. The present series did not use antibiotic-coated cylinders in all cases, and the high-comorbidity profile — including 60.9% diabetes mellitus and 47.8% antiplatelet use — confers elevated baseline risk. Review of the three infected patients revealed a shared clinical pattern: all had independently discontinued their prescribed antidiabetic medications prior to surgery without medical supervision, resulting in unrecognized perioperative hyperglycemia. This underlines the importance of rigorous pre-operative metabolic verification and explicit patient education that medication compliance must be maintained up to and including the day of surgery.
Functional Outcomes
Mean patient satisfaction was 9.68 ± 0.65/10 (n=69). Mean partner satisfaction was 9.19 ± 0.96/10 (n=63; data unavailable for 6 patients). Mean time to first device use was 4.4 ± 1.2 weeks (range 3–8 weeks; n=68). Device activation was performed at 3 weeks in all patients per protocol. Mean follow-up duration was 5.3 ± 2.5 months (range 1–11 months). Functional outcome data are presented in Table 4.
Table 4: Functional Outcomes
|
Outcome Measure |
Result |
n |
|
Patient satisfaction score (0–10) |
9.68 ± 0.65 |
69 |
|
Partner satisfaction score (0–10) |
9.19 ± 0.96 |
63 |
|
Mean time to first device use (weeks) |
4.4 ± 1.2 (range 3–8) |
68 |
|
Device activated at 3 weeks (per protocol) |
69 (100%) |
69 |
|
Mean follow-up duration (months) |
5.3 ± 2.5 (range 1–11) |
69 |
Abbreviations: IIEF: International Index of Erectile Function. Partner satisfaction data unavailable for 6 patients.
Single-Surgeon Protocol: Rationale and Evidence
The elimination of surgical task delegation is the defining methodological feature of this protocol. Carson et al., demonstrated that Staphylococcus epidermidis — a constituent of normal cutaneous flora — is the predominant organism in prosthesis infection and that the majority of infections arise from intraoperative inoculation rather than haematogenous seeding [14]. By restricting all device contact to a single operator with a standardized two-glove-change protocol, this series minimizes contamination vectors to an irreducible minimum. The sequential five-minute chlorhexidine gluconate scrub followed by a betadine overlay represents a dual-agent broad-spectrum antiseptic approach supported by meta-analytic evidence in prosthetic implant surgery [15].
Technical Refinements: Stay Suture Placement, Corporotomy Length, and Cross-Dilator Technique
Three intraoperative technical details of this protocol merit specific discussion as they have not been collectively described in prior published series. First, stay sutures are placed with a minimum 9 cm maintained distally from the coronal sulcus; this ensures adequate cylinder tip reach to the glans and prevents distal cylinder shortfall — a cause of functional dissatisfaction and Concorde deformity. Second, corporotomy length is deliberately limited to no more than 2 cm per side; a larger opening increases hemorrhage, tissue trauma, and the risk of cylinder extrusion at the closure site. Third, after dilation to size 12, the contralateral dilator is placed in the completed cavity whilst the ipsilateral side is advanced to sizes 13 and 14. This cross-dilator technique keeps each corpus continuously dilated, preventing elastic recoil that would otherwise narrow the lumen between dilator passes and complicate subsequent cylinder passage. Collectively, these three technical details represent reproducible, low cost refinements that address common points of failure in PPI.
Reservoir Placement and Pre-Corporotomy Timing
The intrapelvic approach via the same penoscrotal incision — used in 94.2% of cases — avoids the peritoneal cavity and is particularly advantageous in patients with prior pelvic surgery, obesity, or bilateral inguinal hernia [16-18]. The pre-corporotomy timing of reservoir insertion — performed while the field is entirely bloodless — eliminates potential seeding of the reservoir pocket and allows accurate tubing length measurement. No reservoir-related complications occurred in this series.
Patient and Partner Satisfaction
Patient satisfaction of 9.68/10 (96.8%) is among the highest reported in the peer-reviewed literature. Ohl et al., reported satisfaction of 92–96% in a large multicenter prospective series [19]; Levine et al., cited 85–95% across major series [20]. The high scores likely reflect: thorough preoperative counselling during the Doppler consultation; rapid return to function via the three-week activation protocol; and the profound cultural significance of erectile restoration in a Middle Eastern population [21]. Partner satisfaction of 9.19/10, where captured, was consistent with evidence that prosthesis benefits extend meaningfully to the couple’s relationship [22].
Comparison with International Literature
Table 5 contextualizes the present series against selected published benchmarks. The present series compares favorably on satisfaction, mechanical failure, erosion, and — notably — revision surgery rate (0.0%) across all reference comparators. The 4.3% infection rate is higher than the 1.1% reported by Mulcahy using antibiotic-impregnated AMS 700, attributable to the absence of universal antibiotic coating and the higher risk comorbidity profile; however, the conservative management success (prosthesis retained in all infected cases without revision surgery) represents a clinically meaningful outcome that is not captured by infection rate alone. The 0.0% mechanical failure rate likely reflects the short mean follow-up of 5.3 months; long-term data will be reported at five years.
Table 5: Comparison with Selected International Published Series
|
Metric |
This Series (n=69) |
Mulcahy 2011 (AMS 700) |
Carson et al. 2011 |
Levine et al. 2016 |
|
Series size (n) |
69 |
372 |
~500 |
~800+ |
|
Infection rate |
4.3% |
1.1%* |
~2–3% |
~1–3% |
|
Mechanical failure |
0.0% |
~4–5% (5-yr) |
~5–7% |
~5% |
|
Corporal perforation |
2.9% |
~2–4% |
~2–4% |
~2–5% |
|
Revision surgery rate |
0.0% |
~5–8% |
~5–10% |
~5–8% |
|
Patient satisfaction |
9.68/10 (96.8%) |
~92–96% |
~90–95% |
~85–95% |
|
Redo proportion |
7.2% |
~10–15% |
~10% |
~10–15% |
* AMS 700 InhibiZone antibiotic-coated device used throughout; lower baseline infection rate expected. Present series used mixed brands without universal antibiotic coating.
Limitations
This study has several limitations. Follow-up is relatively short (mean 5.3 months); five-year mechanical survival data are not yet available. IIEF scores were incompletely collected and are a priority for prospective data collection. The single-surgeon design maximizes protocol consistency but limits generalizability to multisurgeon settings. The cohort size, while the largest from the UAE, is modest relative to large registry studies. No control cohort was available for comparative inference.
CONCLUSION
This prospective single-surgeon series from Dubai establishes a detailed, reproducible template for three-piece inflatable penile prosthesis implantation that achieves outcomes consistent with international standards in a high-comorbidity, multicultural patient population. Zero mechanical failures, zero erosions, zero revision surgeries, 4.3% infection rate (all primary cases, all successfully managed conservatively with daily wound dressing and extended antibiotic therapy with prosthesis retention), and mean patient satisfaction of 9.68/10 collectively demonstrate the clinical effectiveness of the described protocol.
The core tenets — surgeon-performed sequential dual agent antisepsis, pre-corporotomy intrapelvic reservoir placement, minimum 9 cm distal stay suture placement, limited 2 cm corporotomy, cross-dilator technique from size 12, systematic intraoperative perforation checks, structured two-week post-operative surveillance, and a three/four-week activation program — are individually evidence-based and collectively constitute a coherent, transferable quality framework.
Future directions include systematic IIEF pre- and post operative scoring, long-term five-year mechanical survival analysis, dedicated subgroup analyses by aetiology and primary versus redo status, and participation in a regional GCC prosthetics registry.
ACKNOWLEDGEMENTS
The author thanks all patients who participated in this study and consented to the use of their anonymized data. No financial support or grant funding was received.
Conflict of Interest
The author declares no financial relationships, consultancy agreements, or conflicts of interest with any prosthesis manufacturer mentioned in this manuscript.
Author Declarations
Author Contributions: Khaled Natheer Altopajee (KAA): sole surgeon and investigator; study conception and design; data collection and prospective maintenance; data analysis; manuscript drafting, revision, and final approval.
Data Availability
Fully anonymized individual patient data are available from the corresponding author upon reasonable written request, subject to applicable UAE data protection regulations.
Ethical Approval
All procedures were performed in accordance with the Declaration of Helsinki (1964) and its later amendments. All patients provided written informed consent.
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