Biomedical subjects

Wallace W Dinsmore

Publications and source records attributed to Wallace W Dinsmore.

3 recordsLinked to original sources

PubMed2006

Topical eutectic mixture for premature ejaculation (TEMPE): a novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation.

OBJECTIVE: To evaluate, in a phase II study, the efficacy and safety of a topical eutectic mixture for premature ejaculation (TEMPE), a metered-dose aerosol spray containing a eutectic mixture of lidocaine and prilocaine, as a treatment for PE. PATIENTS AND METHODS: Men with PE (Diagnostic and Statistical Manual-IV definition) aged 18-75 years were randomized into a double-blind, placebo-controlled study in the UK and the Netherlands. Efficacy variables included the mean change in intravaginal ejaculatory latency time (IELT) from baseline and the proportion of patients who achieved an IELT of > or = 4, > or = 3 or > or = 2 min on two occasions, and the effect of TEMPE on the index of ejaculatory control (IEC) and sexual quality-of-life (SQoL) scores of patients and their partners. Safety and adverse event data were also collected. Fifty-four patients were randomized and received study treatment. RESULTS: The observed mean change in IELT from baseline to the end of the treatment period was 3.8 min in the TEMPE group and 0.7 min in the placebo group, and when adjusted for baseline and centre was 2.4 times higher in the TEMPE than the placebo group (P < 0.01). The efficacy of TEMPE in increasing IELT was further supported by positive trends in the other efficacy endpoints. The proportion of men who had an IELT time > or = 2, > or = 3 or > or = 4 min on two occasions after treatment was 11/20 (55%), 8/20 (40%) and 5/25 (20%) in the TEMPE group, and 8/23 (35%), 3/23 (13%) and 3/23 (13%) in the placebo group, respectively, although these differences were not statistically significant. Improvements in IEC and SQoL (male and female) scores also showed trends towards greater efficacy for TEMPE than placebo. In all, 35 of 42 (83%) patients considered the spray easy to use. Mild to moderate local numbness occurred in three (12%) of the TEMPE-treated patients but did not lead to discontinuation. CONCLUSION: Topical treatment with TEMPE produced a statistically and clinically significant increase in IELT compared with placebo, and resulted in positive trends in ejaculatory control and SQoL. TEMPE was considered easy to use and was well tolerated. The data support the conduct of further large-scale studies to establish the utility of TEMPE as a first-line treatment for PE.

Administration, Topical↗

PubMed2006

Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies.

OBJECTIVE: To validate the Sexual Assessment Monitor (SAM), a novel apparatus designed to collect electronic data on ejaculatory latency time (ELT) for diagnosing premature ejaculation (PE), and for accurately measuring treatment outcomes in clinical trials. PATIENTS, SUBJECTS AND METHODS: Men with PE, and healthy volunteers aged 18-75 years, were enrolled in three open-label studies, conducted in the UK. The SAM, which consists of a control box with two front attachments, a vibrator and sensor, was attached to the penis. The vibrator, which provides stimulation, was positioned at the frenulum using a soft cuff; the vibrator intensity was set at 80 units for most subjects. The sensor is an indium-gallium elasticated loop, which was positioned around the base of the penis to detect ejaculatory pulses. These pulses were transmitted to a data recorder in the control box. The data, which are displayed graphically as traces, were automatically classified by a computer-generated algorithm to quantify ELT. RESULTS: In all, 53 healthy volunteers and 58 men with PE provided 213 and 195 evaluable records, respectively. Most were complete records (99% and 96%). The pooled data showed that the ELT was much higher for healthy volunteers than for men with PE (geometric means: 687 vs 169 s, respectively), with a healthy volunteer to PE patient ratio of 2.87 (P < 0.001). Only 6.3% of subjects reported mild adverse events, which were unrelated to the SAM. CONCLUSIONS: These open-label studies show that the SAM can consistently and safely measure times to erection (from the start of vibration) and ejaculation, and ELT in healthy volunteers and men with PE. These findings show that the SAM has the potential to become the 'gold standard' in the diagnosis of PE and in clinical trials design.

Adolescent↗

PubMed2005

Available and future treatments for erectile dysfunction.

There is now a range of treatments for patients with erectile dysfunction (ED) beyond the psychosexual counselling and surgical implants that were the only available management options for many years. Oral treatments, which are minimally invasive, are the favoured first-line option for treatments and include the phosphodiesterase-5 (PDE5) inhibitors, and dopamine agonists such as apomorphine. Psychosexual counselling may still be an appropriate treatment, on its own or in combination, in a minority of patients who do not respond to oral treatment, or where an origin for the ED is likely from the history. The PDE5 inhibitors, sildenafil, tadalafil, and vardenafil, have proven to be effective and well tolerated and facilitate erectile function. Apomorphine is also effective, but causes nausea in a minority of men. The alpha-receptor antagonist yohimbine has been found to be effective in some placebo-controlled trials, but its effectiveness is probably inadequate for treatment of most ED. Intracavernosal injection of drugs such as prostaglandin E1, papaverine, and phentolamine (sometimes in combination) is an effective but invasive treatment. Other treatments include testosterone, vacuum-pump treatment, surgery, and surgical implants, and tend to be used where patients do not respond to oral treatment and counselling.

Apomorphine↗