(256) Sexual Function and Andrology Parameters in Men after Treatment of Anterior Urethral Strictures with the Optilume Drug Coated Balloon
Bibliographic record
Abstract
Abstract Introduction The Optilume Urethral Drug Coated Balloon (DCB) is a novel endoscopic treatment for recurrent male anterior urethral strictures. An important topic of discussion with patients during counseling on treatment options includes the potential affect of treatment on sexual function and fertility. The ROBUST III study was a prospective, randomized study comparing standard of care endoscopic therapy against treatment with the Optilume DCB. Assessments included evaluation of sexual function and andrology parameters. Objective The objective was to study the potential affect of treatment with the Optilume DCB on sexual function and, for younger patients, fertility. Methods A total of 79 men were randomized to receive treatment with the Optilume DCB. Sexual function was assessed via the 15 item International Index of Erectile Function (IIEF) questionnaire. Erectile function, orgasmic function, and overall satisfaction sub-domains were assessed at 3, 6, and 12 months after treatment in patients that were sexually active at baseline. Fifteen additional subjects were enrolled in a non-randomized pharmacokinetic sub-study that included assessments of paclitaxel concentration in semen and sperm quality parameters through 6 months post-treatment. Results Average erectile function and overall satisfaction scores improved from baseline to 12 months post-treatment, while orgasmic function was not changed (Figure). The improvement in satisfaction was statistically significant at 12 months (p=0.003). No adverse events of de novo erectile or ejaculatory dysfunction were reported. Average ejaculate sperm concentration did not change from baseline to 6 months (49 million/mL vs 46.6 million/mL, p=0.88), nor did total spermatozoa per ejaculate (107.2 million vs 104.0 million, p=0.94). Paclitaxel concentration in semen after treatment was maximal at 30 days (2.99 ng/mL) and was reduced near the limit of quantitation of the analytical method by 6 months (0.12 ng/mL). Conclusions Treatment of male anterior urethral strictures with the Optilume DCB did not appear to have an impact on sexual function as measured by the IIEF and adverse event assessments. Average sperm quality parameters did not differ from baseline to 6 months post-treatment. Low levels of paclitaxel were detected in semen after treatment but were nearly undetectable by 6 months. Disclosure Yes, this is sponsored by industry/sponsor: Urotronic Inc. Clarification Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Sci, Coloplast, Medtronic USA Inc., PROCEPT BioRobotic Corporation, NeoTract Inc., Janssen Biotech Inc., Endo Pharmaceuticals Inc., Tolmar Pharmaceuticals, Inc., 180 Medical Inc., AbbVie Inc., Pfizer Inc., Bluewind Medical, Astellas Pharma US Inc., Antares Pharma Inc., Axonic Modulation Technologies Inc., Allergan Inc., Terumo Medical Corporation, Dendreon Pharmaceuticals llc, Blue Earth Diagnostics Limited, Ferring Pharmaceuticals Inc., Olympus America Inc., Karl Storz Endoscopy-America, Clovis Oncology Inc., Dornier MedTech America Inc., Travere Therapeutics Inc., Valeant Pharmaceuticals North America LLC
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".