What randomized trials historically exist comparing AMS 700 series and Coloplast Titan and what were their designs?
Executive summary
Only a single randomized clinical trial directly compared implanted AMS 700™ CX and Coloplast Titan® devices in patients undergoing penile prosthesis with intraoperative modeling; that trial randomized 138 Peyronie’s disease patients (88 to AMS, 50 to Coloplast) and focused on curvature correction, device performance and short‑term outcomes [1] [2] [3]. Other published “randomized” work in the field consists largely of small device‑preference experiments or randomized presentation orders rather than randomized implant trials, and most comparative literature remains observational or retrospective [4] [5] [6].
1. The randomized implant trial that actually exists: Chung et al. — scope and headline finding
The only randomized trial reported in the comparative literature randomized 138 men with Peyronie’s disease and erectile dysfunction to receive either AMS 700™ CX or Coloplast Titan® at the time of prosthesis implantation and intraoperative manual modeling; 88 patients received the AMS device while 50 received the Coloplast device [1] [2]. The published accounts conclude that both devices provided durable penile straightening and similarly high patient satisfaction without an increased revision rate in that cohort, findings summarized in journal abstracts and subsequent reviews [3] [1].
2. Design details of the Chung randomized trial: population, intervention, and outcomes reported
The trial enrolled patients with Peyronie’s disease undergoing inflatable penile prosthesis placement and used intraoperative manual modeling as part of the corrective maneuver — that is, all randomized subjects underwent the same surgical remodeling technique at implantation, so the randomization compared device types within a PD/modeling context rather than comparing device-alone effects in an unselected ED population [1] [2]. Reported sample sizes (138 total with 88 AMS and 50 Coloplast) and primary outcomes focused on curvature correction, need for revision, and patient satisfaction; exact follow‑up durations, power calculations, and detailed mechanical‑failure stratification are cited in source summaries but full granular trial methodology is variably reported across the available abstracts and reviews [1] [3] [2].
3. Other randomized or randomized‑style experiments and what they did — pump preference and bench tests
Separate randomized or randomized‑order studies exist that are not implantation trials: for example, a prospective study randomized the order in which patients handled three pumps (Coloplast Titan, Coloplast Titan Touch, AMS 700) to assess ease of inflation and the effect of key‑pinch strength on pump preference; in that study the Titan pump was favored most often, AMS 700 was favored by 29%, and presentation order was randomized to reduce bias [4]. Biomechanical laboratory comparisons and cadaver testing (non‑randomized) have assessed axial rigidity, kink resistance, girth/length change and three‑point flexure, reporting differences between AMS variants (LGX, CX) and Titan in measures such as digital inflection rigidometer (DIR) scores and kink pressures [5] [7].
4. How the rest of the literature frames comparative evidence and the principal limitations
Systematic reviews and narrative overviews repeatedly emphasize that comparative randomized evidence is scant — most reports are cohort studies, retrospective series, bench tests, or mixed‑design registries, and meta‑analyses therefore rely heavily on nonrandomized data [5] [6] [2]. Reviews note device‑specific mechanical failure patterns (Coloplast more tubing fractures; AMS failures more diffusely distributed) and variable satisfaction rates, but they also highlight heterogeneity in cohorts (Peyronie’s disease vs. ED only), inconsistent stratification by device model (AMS 700 variants vs Titan variants), and limited long‑term randomized follow‑up published in peer‑reviewed form [8] [7] [9].
5. Bottom line and how to read the evidence
For anyone seeking randomized evidence directly comparing implanted AMS 700 and Coloplast Titan devices, the field offers essentially one randomized implantation trial limited to Peyronie’s disease patients who all underwent manual modeling (138 patients, 88 AMS vs 50 Coloplast), supplemented by randomized‑order pump‑preference experiments and extensive nonrandomized observational and laboratory studies; broader claims about superiority, durability or failure profiles therefore rest largely on nonrandomized data and heterogeneous endpoints rather than multiple large randomized trials [1] [4] [5] [8]. Where specific methodological details or certain long‑term outcomes are not provided in the sources, reporting is limited and readers should interpret comparative claims in the context of cohort composition, surgical adjuncts (modeling), and device‑model heterogeneity [2] [1].