A Hyaluronic Acid-Based Procedure for Premature Ejaculation
Materials and Methods
Patients
A total of 171 male patients were screened between June 2009 and March 2011. A hundred and ten male patients, aged between 25 and 42 years (32.78±0.33; mean±standard error of the mean (s.e.m.)), affected by PE, were included in this study. For the purposes of the present investigation, PE was defined as involuntary ejaculation during foreplay or within 1 min of penetration on at least 50% of occasions when attempting intercourse. Patients were selected at our clinic where the study was performed. Inclusion criteria were a stable, monogamous and heterosexual relationship for at least 12 months. Exclusion criteria were a history of medication that can affect ejaculation 6 months before the beginning of the study, a history of drug abuse within 2 years before enrollment for the procedure, a history of or current major psychiatric disorder (psychiatric consultation was conducted at the time of enrollment), such as mood and anxiety disorders, schizophrenia, other psychotic disorders, alcoholism, erectile dysfunction and patients' or partners' decreased interest in sexual intercourse or other forms of sexual dysfunction. No other medication of psychotherapy was allowed during the study period.
Surgical Procedure
The present study was performed according to the Helsinki declaration and local internal review board approval was obtained (it is available for viewing upon request from the Editor-in-Chief). All patients signed the informed consent. Each patient, comfortably sitting, was injected with a 28-G needle containing 1 ml of 1% lidocaine and prilocaine (Astra Pharmaceuticals, Milan, Italy) to induce local anesthesia. The circumference of the glans penis (deep connective tissue of the corpus spongiosum) was divided into three circles (from the base of the glans at a 1-cm distance from each other). The circles were then divided into quarter circles. An injection, containing 1 ml hyaluronic acid (Variofill; Adoderm GmbH, Langenfeld, Germany) was performed in the deep dermis into every quarter circle with a 27-G needle for a total of 12 injections performed in a single session (Figure 1). The patients' and partners' satisfaction was rated on the basis of a scale 1–10 (1=dissatisfied; 10=satisfied). IELT, a subjective measure defined as the time between the start of vaginal intromission and the start of intravaginal ejaculation, was evaluated for each couple. Evaluations about the increase of glans circumference and patients' and partners' satisfaction were also performed. Following the procedure, the patients did not receive any further aesthetic treatment.
(Enlarge Image)
Figure 1.
(a–c) The circumference of the glans penis is virtually subdivided into three circles (starting from the base of the glans penis at a distance of 1 cm from each other). Then, each circumference is further subdivided into quarter circles where 1 ml of hyaluronic acid is injected.
Patients and partners were asked to self-rate their satisfaction with sexual intercourse before and after the procedure, using a scale from 1 to 6 (1=not satisfied; 6=very satisfied). This information was collected by an allied health-care professional and kept in our clinic database.
Statistical Analysis
All data are represented as the means±s.e.m., and were first checked for normality using the Anderson–Darling test. All statistical analysis was conducted using Minitab, v15, Leeds, UK. A paired t-test was used to compare IELT and maximal glandular circumference before and after treatment. A value of P<0.05 was considered significant.