Journal of Andrology
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Published-Ahead-of-Print April 23, 2009, DOI:10.2164/jandrol.108.007344
Journal of Andrology, Vol. 31, No. 2, March/April 2010
Copyright © American Society of Andrology
DOI: 10.2164/jandrol.108.007344

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A Novel Treatment Modality in Patients With Premature Ejaculation Resistant to Conventional Methods: The Neuromodulation of Dorsal Penile Nerves by Pulsed Radiofrequency

SEREF BASAL*, SERDAR GOKTAS*, ATILLA ERGIN{dagger}, IBRAHIM YILDIRIM*, ABDULKADIR ATIM*, LUTFI TAHMAZ* AND MURAT DAYANC*

From the * Department of Urology and the {dagger} Department of Anesthesiology, Gülhane Military Medical Academy, Ankara, Turkey.

Correspondence to: Dr Seref Basal, Department of Urology, Gülhane Military Medical Academy, School of Medicine, 06018 Ankara, Turkey (e-mail: serefbasal{at}gmail.com).
Received for publication December 9, 2008; accepted for publication April 23, 2009.

   Abstract
 Top
 Abstract
 Materials and Methods
 Results
 Discussion
 References
 
Premature ejaculation (PE) is the most common sexual problem experienced by men, and it affects 20%–30% of them. Pulsed radiofrequency (PRF) neuromodulation has been shown to be an effective treatment for a wide range of pain conditions. We used PRF to treat PE by desensitizing dorsal penile nerves in patients resistant to conventional treatments. Fifteen patients with a lifelong history of PE, defined as an intravaginal ejaculatory latency time (IELT) of <1 minute that occurred in more than 90% of acts of intercourse and was resistant to conventional treatments, were enrolled in this study. Patients with erectile dysfunction were excluded. The mean age of the patients was 39 ± 9 years. Before and 3 weeks after the treatment, IELT and sexual satisfaction score (SSS; for patients and their partners) were obtained. The mean IELTs before and 3 weeks after procedure were 18.5 ± 17.9 and 139.9 ± 55.1 seconds, respectively. Side effects did not occur. Mean SSSs of patients before and after treatment were 1.3 ± 0.3 and 4.6 ± 0.5, and mean SSSs of partners before and after treatment were 1.3 ± 0.4 and 4.4 ± 0.5, respectively. In all cases, IELT and SSS were significantly increased (P < .05). None of the patients or their wives reported any treatment failure during the follow-up period. The mean follow-up time was 8.3 ± 1.9 months. It is early to conclude that this new treatment modality might be used widely for the treatment of PE; however, because it is an innovative modality, placebo-controlled studies (eg, sham procedure), with larger numbers of patients and including assessment of penile sensitivity (eg, biothesiometry), are needed.

     Key words: Sexual dysfunction, andrology



Premature ejaculation (PE) is the most common sexual problem experienced by men, and affects 20%–30% of them (Laumann et al, 1999). PE has many definitions (Paick et al, 1998).

A new definition for PE proposed by members of the International Society for Sexual Medicine Ad Hoc Committee was as follows: PE is the inability to delay ejaculation time from penetration to ejaculation that always or nearly always occurs before or within 1 minute of vaginal penetration (McMahon et al, 2008).

Biological and psychological factors are important in the etiology of PE (Morales et al, 2007). Patients with primary PE have penile hypersensitivity, which provides further evidence for an organic basis of PE (Xin et al, 1996). The hypothesis is that reducing the sensitivity of the glans penis with topical desensitizing agents (eg, local anesthetics) would delay ejaculatory latency without adversely affecting the sensation of ejaculation. However, in applying a local anesthetic to the penis, there is, of course, the theoretical possibility of penile hypoesthesia, transvaginal contamination, and female genital anesthesia (Morales et al, 2007).

Despite its side effects, such as numbness, paresthesia, pain for neuroma, and erectile dysfunctions, dorsal neurectomy is still performed to decrease the sensitivity of glans penis in selected patients resistant to conventional treatments (Tullii et al, 1994; Kim et al, 2004).

Pulsed radiofrequency (PRF) neuromodulation has been shown to be an effective treatment for a wide range of pain conditions (Saberski et al, 2000; Geurts et al, 2001). Recently Cohen and Foster (2003) reported 3 patients with groin pain or orchialgia who were successfully treated using PRF of the nerves innervating the area.

In this study we used PRF for neuromodulation of dorsal penile nerves (DPNs) in patients with PE who were resistant to conventional treatments of PE. To our knowledge, this treatment modality has not been reported previously.


Figure 1
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Figure 1. A 22-gauge, 5-cm long RFK cannula with a 5-mm active tip (RFK-C10D-S, Tyco) was introduced into the skin of the radix penis at the 11-o'clock position to apply pulsed radiofrequency to the dorsal penile nerve. Color figure available online at www.andrologyjournal.org.

 

   Materials and Methods
 Top
 Abstract
 Materials and Methods
 Results
 Discussion
 References
 
Fifteen patients with a lifelong history of PE, defined as an intravaginal ejaculatory latency time (IELT) of <1 minute that occurred in more than 90% of acts of intercourse and was resistant to conventional treatments (selective serotonin reuptake inhibitors, topical agents, psychological treatments, behavioral training techniques) of PE were enrolled in this study. The IELT was the time between the start of vaginal insertion and the start of intravaginal ejaculation (Waldinger et al, 1994). The mean age of patients was 39 ± 9 years. None of the patients had any treatment in the last 1.5 months. All patients were married, had a stable relationship with their wives, and had possible sexual intercourse 1–2 times per week. Before the treatment, all patients underwent self-administration of the International Index of Erectile Function-5, and patients with erectile dysfunction were excluded from the study. Patients with any risk factors for impotence, such as hypertension, diabetes mellitus, neurological disease, extensive alcohol use, or the use of any medication known to cause sexual dysfunction, were also excluded from the study. The exclusion criteria were as usual for studies in men with PE (Hirsch el al, 2004).

After the procedure and possible side effects were explained to patients, all subjects gave their written informed consent before entering the study, which was conducted in accordance with the Declaration of Helsinki. The local Medical Ethical Committee approved the study.

Under sterile conditions, a 22-gauge, 5-cm-long RFK cannula with a 5-mm active tip (RFK-C10D-S; Tyco Healthcare Group, Hampshire, England) was introduced into the skin of the flaccid penis at the 11-o'clock position to apply PRF to the right DPN (Figure 1). The stylet was then removed and the radiofrequency probe inserted through the needle (Figures 2 and 3). The energy used in both situations (the sensory stimulation testing and the application of actual PRF), was lower than 0.45 V. First sensory stimulation testing was performed at 50 Hz, and the needle location was redirected based on the patient's identification of the point of maximal stimulation where the patient reported the most intense sensation. We considered the intense sensation point as the most appropriate place for PRF neuromodulation of DPN. Afterwards, the PRF procedure was performed (Figures 2 and 3). The impedance ranged from 200 to 450 ohms. PRF procedures were performed with a setting of 2 x 20 ms/s with a generator output (RFG-1A Radiofrequency Generator; Cosman Medical, Inc, Burlington, Massachusetts) of 45 V for a duration of 180 seconds at 42°C. The RFK cannula was introduced into the skin of the flaccid penis at the 1-o'clock position to apply PRF to the left DPN and the same procedure was repeated on the right DPN. By this procedure, we aimed to ablate sensation over as large an area of the glans penis as possible. PRF was performed by the same physician to avoid interpersonal variations.


Figure 2
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Figure 2. Insertion of radiofrequency probe through RFK cannula. Color figure available online at www.andrologyjournal.org.

 

Figure 3
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Figure 3. Illustration of application of pulse radio frequency to penile dorsal nerve. Illustrated by I.Y.

 

The patients were evaluated before and 3 weeks after the treatment. Every patient's wife was asked to measure baseline IELT using a stopwatch at 4 different times in 4 weeks, at least 24 hours apart from each other, before and 3 weeks after treatment. If consecutive acts of intercourse occurred, IELT was measured for the first intercourse attempt. All patients and their wives were asked to indicate their sexual satisfaction on a scale of 0–5 as proposed by Kim and Paick (1999) with 0 being extremely dissatisfied and 5 extremely satisfied before and 3 weeks after treatment. The shortest follow-up time was 4.7 months and the longest was 10.8 months for subjective evaluation.

First, the geometric mean of IELT (Waldinger et al, 2008) was calculated for each patient, and then mean ± standard deviation and median (minimum–maximum) IELT were obtained before and after the procedure. The difference between before and after treatment was compared with Wilcoxon signed-rank test. A P value of <.05 was accepted as statistically significant.


   Results
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 Abstract
 Materials and Methods
 Results
 Discussion
 References
 
The mean age of the patients was 39 ± 9 (range, 24–56) years. The procedure takes only 10 minutes. No patients had any pain during the procedure. All patients were evaluated 3 weeks after the treatment. No patients had any erection problem, penile hypoesthesia, or pain after the procedure. Sexual satisfaction scores (SSSs) of patients and their wives and IELT were noted. Mean IELTs before and 3 weeks after procedure were 18.5 ± 17.9 and 139.9 ± 55 seconds, respectively. Median IELTs before and 3 weeks after procedure were 9.8 (1–49.5) and 119.9 (71.2–239.9) respectively. All patients experienced a change in IELT, and IELT was significantly increased when compared with initial values (P = .001). Twofold increase in IELT was detected in 2 patients and 3-fold and more increase in IELT was detected in 13 patients. Mean SSSs of patients before and after treatment were 1.3 ± 0.3 and 4.6 ± 0.5 respectively. Mean SSSs of partners before and after treatment were 1.3 ± 0.4 and 4.4 ± 0.5 respectively. The SSS increases in patients and their partners were statistically significant (P < .001; Table). Even though we did not measure IELT after 3 weeks and during the follow-up period, none of the patients or their wives reported any treatment failure during the follow-up period. The mean follow-up time was 8.3 ± 1.9 months.


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Table. Characteristics of patients (n = 15) and the results of the study
 


   Discussion
 Top
 Abstract
 Materials and Methods
 Results
 Discussion
 References
 
Oral drugs, application of a condom, local anesthetics applied to the penis, and penile dorsal neurectomy are treatment modalities in PE. The current treatment choice for PE is medical treatment. Systemic treatments have included adrenergic antagonists (Beretta et al, 1986), {gamma}-aminobutyric acid, and selective serotonin reuptake inhibitors (Girgis et al, 1982; Kara et al, 1996; McMahon, 1998; McMahon and Touma, 1999a,b; Andersson et al, 2006). Success with these agents has been variable and is associated with side effects.

In hypersensitivity of the glans penis, various topical agents have been applied. Reducing this heightened sensitivity of the glans penis with topical desensitizing agents might therefore be a way of improving IELT without adversely affecting the sensation of ejaculation (Kim et al, 2004; Dinsmore et al, 2007). Dinsmore et al (2007) reported that reducing penile sensitivity with an aerosol contain lidocaine-prilocaine prolongs IELT significantly in patients with PE. Placebo-controlled studies in the literature reported a significant increase in IELT for topical treatments compared with baseline or placebo (Choi et al, 2000; Dinsmore et al, 2007).

The main limitation of medical treatment for PE is recurrence after withdrawal of medication. There are some difficulties with medical treatment. A patient must use drugs (local or oral) before every instance of sexual intercourse. The drugs may cause systemic (allergic reactions, sedation, effects on cognitive functions, and limitations using with other drugs) and local (penile hypoesthesia, transvaginal contamination, and female genital anesthesia) problems. In our study, every patient had a history of medical treatment.

Dorsal neurectomy is also used to decrease the sensitivity of the glans penis. Despite its side effects, such as numbness, paresthesia, pain for neuroma, and erectile dysfunction, dorsal neurectomy is still performed in selective patients resistant to conventional treatments of PE (Tullii et al, 1994).

PRF neuromodulation has been recently described as an alternative technique to apply relatively high voltage near a nerve without nerve injury (Slappendel et al, 1997). Electric field rather than temperature-induced changes in the nerve cells have been suggested to be responsible for the pain relief (Slappendel et al, 1997; Sluijter et al, 1998).

In the human glans penis, the ratio of free nerve ending to corpuscular receptors is 10:1. The free nerve endings are derived from thin myelinated A{alpha} and unmyelinated C fibers (Halata and Munger, 1986). The nerve fibers from the receptors converge to form bundles of the dorsal nerve of the penis, which joins other nerves to become the pudendal nerve. Activation of these sensory neurons sends messages of pain, temperature, and touch by means of spinothalamic and spinoreticular pathways to the thalamus and sensory cortex for sensory perception.

There are various theories on the etiology of PE. It is now generally accepted that both biological and psychological factors are important in the etiology of PE. Men with PE appear to have a heightened sensory response to penile stimulation, with a vibration threshold significantly lower than that of normal men (Kim and Paick, 1999; Dinsmore et al, 2007). IELT is the most commonly used measure (reported in 40% of studies) for establishing PE. It is usually measured with a stopwatch operated by the female partner. There appears to be little consensus as to how to define PE (or indeed normality) in terms of time to ejaculation, and PE has been variously defined as IELTs of 1–4 minutes, which overlaps considerably with a "normal" duration of sexual intercourse of 2–7 minutes (Kim and Paick, 1999; Waldinger, 2003).

Because the glans penis is innervated by the DPNs, in this study we used PRF to treat PE by desensitizing DPNs in 15 patients. With this technique, we successfully increased IELT, probably due to a decrease in sensitivity of the glans penis. To our knowledge, this is the first report of PRF use for the treatment of PE.

Our procedure takes only 10 minutes, and no other medications are needed. This is a minimally invasive technique comparable to dorsal neurectomy. PRF neuromodulation is a minimally invasive procedure with the advantages of absence of any numbness, paresthesia, pain, neuroma formation, or erectile dysfunction.

We think it is early to conclude that this new treatment modality might be used widely for the treatment of PE. The lack of a placebo control arm and objective data on change in sensation (biothesiometry) and the short term of objective follow-up data are the significant limitations of this study. However because this is an innovative modality, placebo-controlled studies (eg, sham procedure), with larger numbers of patients, including assessment of penile sensitivity (eg, biothesiometry) are needed.


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 Materials and Methods
 Results
 Discussion
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