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 5 Products   0 Diseases   5 Products   8 Trials   64 News 
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Enrollment change, Trial withdrawal:  Prophylactic Analgesia for Bladder Botox Injections (clinicaltrials.gov) -  Jul 17, 2025   
    P4,  N=0, Withdrawn, 
    N=120 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group, isoflurane / Generic mfg.
    Preclinical, Journal:  Integrated assessment of continuous uroflow cystometry and visceromotor responses to bladder distension in urethane-anesthetized mice. (Pubmed Central) -  Jun 30, 2025   
    Mice were first anesthetized with 1.75% isoflurane inhalation for the surgical implantation of a bladder catheter and stainless-steel wire electrodes to the external oblique musculature for delivering bladder distension and recording muscular response respectively...Intravesical infusion of acetic acid significantly enhanced the VMR to grader bladder distension and disrupted the regular micturition cycles, which were normalized by intravesical lidocaine...SIGNIFICANCE STATEMENT: A urethane anesthesia protocol was optimized for robust cystometrogram and visceromotor response recordings in mature and aged mice. This model allows assessment of bladder physiology and pain, demonstrating that acetic acid disrupts micturition and enhances pain responses, which lidocaine normalizes.
  • ||||||||||  Invicorp (aviptadil/phentolamine mesilate) / Regent Pacific Group
    Retrospective data, Journal:  Intracavernosal injection of aviptadil and phentolamine for refractory erectile dysfunction. (Pubmed Central) -  May 13, 2025   
    The overall lack of high quality studies emphasises the need for clinicians to be critical in their evaluation of the published literature on the management of this perplexing condition. Almost 60% of the participants with refractory ED were successfully managed through the administration of AvP.
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Journal:  Alkalinised lidocaine as an anaesthetic before onabotulinumtoxinA injections. a randomised trial. (Pubmed Central) -  Mar 17, 2025   
    P3
    Almost 60% of the participants with refractory ED were successfully managed through the administration of AvP. Intravesical instillation of alkalinised lidocaine before BTX-A injections significantly reduced VAS pain scores compared to placebo (ClinicalTrials.gov identifier: NCT05415865).
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    A Novel Technique for Intravesical Anesthesia During Intravesical Botox Administration (Marco Polo 703; In Person) -  Mar 6, 2025 - Abstract #AUA2025AUA_2706;    
    This procedure eliminates the need for straight catheterization and instillation of 30-40 mL of intravesical lidocaine with a 20-30 minute dwell time in the bladder. Eliminating dwell time and straight catheterization to achieve local anesthesia significantly reduces the procedure time and cost.
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    New P4 trial:  Prophylactic Analgesia for Bladder Botox Injections (clinicaltrials.gov) -  Jul 22, 2024   
    P4,  N=120, Not yet recruiting, 
  • ||||||||||  Phenylephrine topical gel (PSD503) / Regent Pacific Group
    Review, Journal:  Pharmacotherapy in Stress Urinary Incontinence; A Literature Review. (Pubmed Central) -  Jun 24, 2024   
    Currently, trials are evaluating novel targets. Systemic adverse effects such as gastrointestinal upset with duloxetine and orthostatic hypotension with ?-adrenoceptor agonists have hampered the efficacy of drugs used to treat SUI in women and men.
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Journal, HEOR, Cost-analysis:  Cost Analysis of Oral Phenazopyridine vs Intravesical Lidocaine for Preprocedural Analgesia for Intradetrusor OnabotulinumtoxinA Injections. (Pubmed Central) -  Jun 24, 2024   
    Phenazopyridine provides cost savings compared to lidocaine for analgesia before office intradetrusor onabotulinumtoxinA injection for the treatment of idiopathic overactive bladder. If adopted by providers nationwide, phenazopyridine may reduce health care spending and minimize office visit time while maintaining patient pain control and satisfaction.
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    A Validated Patient Reported Outcome for Premature Ejaculation (S404C) -  Mar 30, 2023 - Abstract #AUA2023AUA_2552;    
    Under FDA guidance this has been addressed withe the development of the PEBEQ. The data presented show that patients do not necessarily differentiate between distress and bother, in terms of the presenting symptoms of premature ejaculation.
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group
    Review, Journal:  Interventions to improve tolerability of local anesthetic intradetrusor Botulinum toxin injections: A systematic review. (Pubmed Central) -  Nov 17, 2022   
    EMDA of intravesical alkalinized lidocaine, intravesical, alkalinized lidocaine without EMDA, and a reduction in the number of injection site were all associated with improvements in patient tolerability during LA BTA injections. Further research should address which subgroups of patients find the procedure most painful and would benefit most from these interventions.
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Enrollment open:  The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder (clinicaltrials.gov) -  Sep 22, 2022   
    P3,  N=50, Recruiting, 
    Further research should address which subgroups of patients find the procedure most painful and would benefit most from these interventions. Not yet recruiting --> Recruiting
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Journal:  Oral Phenazopyridine vs Intravesical Lidocaine for Bladder OnabotulinumtoxinA Analgesia: A Randomized Controlled Trial (OPIL). (Pubmed Central) -  Jul 28, 2022   
    In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural pain control. Phenazopyridine is well-tolerated by participants, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times.
  • ||||||||||  Priligy (dapoxetine) / AbbVie, Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Journal:  An up-to-date overview of the pharmacotherapeutic options for premature ejaculation. (Pubmed Central) -  Jul 23, 2022   
    Currently, only dapoxetine and an anesthetic spray containing lidocaine and prilocaine (Fortacin™) are officially approved, with the rest being used off-label...Adverse events of any therapy should be taken under consideration. Physicians should encourage patients to discuss their needs and expectations and grade any improvement of their condition with treatment.
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Trial completion, Trial completion date:  PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) -  Jul 5, 2022   
    P2,  N=121, Completed, 
    Physicians should encourage patients to discuss their needs and expectations and grade any improvement of their condition with treatment. Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Dec 2021
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Clinical, Journal:  Real-life use of the eutectic mixture lidocaine/prilocaine spray in men with premature ejaculation. (Pubmed Central) -  Apr 27, 2022   
    Overall, FORTACIN™ emerged to be a safe and effective treatment option in PE patients of various types, with almost one fourth of patients still under treatment after 12 months. Timing and dosing of the drug can deserve to be adjusted according to patient's needs and their sexual ecology.
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Journal:  Prilocaine/lidocaine spray for the treatment of premature ejaculation: a dose- and time-finding study for clinical practice use. (Pubmed Central) -  Mar 23, 2022   
    Our main study findings showed that the treatment regimen with three sprays of Fortacin™ administered 5 min before sexual intercourse showed the best results in terms of ejaculation time and control (Phase I, IELT 221 ± 3.4, PEDT 7.7 ± 0.3; Phase II, IELT 213 ± 4.9, PEDT 7.8 ± 0.4) with a safety profile that was identical to other treatment regimens. Based on these data, patients who are prescribed Fortacin™ should stick to this regimen to optimize treatment results.
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group
    Preclinical, Journal:  Characterization of a method to study urodynamics and bladder nociception in male and female mice. (Pubmed Central) -  Oct 30, 2021   
    In conclusion, this technique can measure the VMR and bladder nociception associated with voiding in both female and male mice. Although confounds still exist with the use of anesthesia, further exploration of non-anesthetized voiding-evoked VMR is warranted.
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group
    [VIRTUAL] Sodium Bicarbonate to Augment Lidocaine's Intravesical Activity: A Randomized, Crossover Study () -  Aug 5, 2021 - Abstract #AUA2021AUA_2999;    
    Although subjective pain scores vary between patients, acting as their own controls limits this bias. With no adverse events and no significant alterations to the office-based procedure, we found sodium bicarbonate is an effective and cost-conscious augmentation to lidocaine instillation for BTX-A therapy.
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Trial completion date, Trial primary completion date:  PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) -  May 21, 2021   
    P2,  N=100, Active, not recruiting, 
    Our preliminary results should be further confirmed in clinical studies. Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Nov 2020 --> May 2021
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Enrollment closed:  PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) -  Oct 28, 2020   
    P2,  N=100, Active, not recruiting, 
    Our findings suggest that intravesical instillation of 1% lidocaine is a useful treatment for OAB. Recruiting --> Active, not recruiting
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group
    Journal:  Onset of the action of intravesical lidocaine after spinal cord injury. (Pubmed Central) -  Oct 10, 2020   
    Utilizing lidocaine's properties to decrease sympathetic-inducing afferents after SCI, the time to onset of action for intravesical lidocaine was found to be approximately 90 seconds. This relatively rapid initial onset on action is especially pertinent when managing autonomic dysreflexia.
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Trial completion date, Trial primary completion date:  OPIL: Oral vs Intravesical Analgesia for Office Bladder Botox Injections (clinicaltrials.gov) -  May 28, 2020   
    P4,  N=110, Recruiting, 
    This relatively rapid initial onset on action is especially pertinent when managing autonomic dysreflexia. Trial completion date: Jun 2020 --> Mar 2021 | Trial primary completion date: Jun 2020 --> Mar 2021
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Trial completion date, Trial primary completion date:  PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) -  May 5, 2020   
    P2,  N=100, Recruiting, 
    Trial completion date: Jun 2020 --> Mar 2021 | Trial primary completion date: Jun 2020 --> Mar 2021 Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Sep 2020
  • ||||||||||  Journal:  Reflexions on 50 Years of Sexual Medicine in Urology Focusing on Male Sexual Dysfunctions (Pubmed Central) -  Feb 21, 2020   
    Regarding premature ejaculation (PE) meanwhile with oral dapoxetine and topical lidocaine/prilocaine spray two effective treatment options are officially available which may be combined in men with severe PE and with PDE-5 inhibitors in men with PE and ED. Hormonal disorders such as hypogonadism, hyperprolactinemia and thyroid disorders may be linked to male sexual disorders and successfully treated with T-substitution, prolactin inhibitors or thyroid specific medications.Whereas vascular surgery for ED such as deep dorsal vein ligation/resection or arterial revascularization procedures dominated the 80ies and 90ies last century they have been considered outdated and are replaced in severe ED of organic etiology by the modern new three piece inflatable penile implants whose high technical standard meanwhile provide 10 years survival rates of about 70 %.
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group
    Retrospective data, Review, Journal:  Reduction of Pain During Flexible Cystoscopy: A Systematic Review and Meta-Analysis. (Pubmed Central) -  Nov 19, 2019   
    The evidence was insufficient for other tested interventions. A prospective study is needed to further clarify interventions to decrease patient discomfort during cystoscopy and other intravesical procedures in a diverse population.
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Enrollment open:  PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) -  Dec 7, 2018   
    P2,  N=100, Recruiting, 
    A prospective study is needed to further clarify interventions to decrease patient discomfort during cystoscopy and other intravesical procedures in a diverse population. Not yet recruiting --> Recruiting
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    Trial completion date, Trial initiation date, Trial primary completion date:  PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) -  Nov 29, 2018   
    P2,  N=100, Not yet recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Oct 2019 --> Mar 2020 | Initiation date: Aug 2018 --> Dec 2018 | Trial primary completion date: Oct 2019 --> Mar 2020
  • ||||||||||  Fortacin (lidocaine/prilocaine spray) / Regent Pacific Group, Recordati
    New P2 trial:  PSD502 in Subjects With Premature Ejaculation (clinicaltrials.gov) -  Jul 5, 2018   
    P2,  N=100, Not yet recruiting, 
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group
    Trial termination:  Local Anesthetic Treatments for Overactive Bladder (clinicaltrials.gov) -  Mar 13, 2014   
    P3,  N=22, Terminated, 
    N=40 --> 0 Suspended --> Terminated; funding ran out, poor accrual.
  • ||||||||||  Urolieve (lidocaine alkalized intravesicular) / Regent Pacific Group
    Enrollment change:  Local Anesthetic Treatments for Overactive Bladder (clinicaltrials.gov) -  Mar 13, 2014   
    P3,  N=22, Terminated, 
    Suspended --> Terminated; funding ran out, poor accrual. N=100 --> 22