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Peripheral Afferent Nerve Stimulation for Treatment of Lower Urinary Tract Irritative Symptoms
European Urology
European Urology 45 (2004) 65–69
Peripheral Afferent Nerve Stimulation forTreatment of Lower UrinaryTract Irritative Symptoms B. Congregado Ruiz*, X.M. Pena Outeirin˜o, P. Campoy Martı´nez, E. Leo´n Duen˜as, A. Leal Lo´pez Servicio de Urologı´a, Hospital Universitario Virgen del Rocı´o, Manuel Siurot S/N, 41012 Sevilla, Spain Accepted 28 August 2003 Published online 2 October 2003
Abstract Objectives: To assess the efficacy of posterior tibial nerve stimulation for treatment of lower urinary tract irritative symptoms (urgency, frequency, urge incontinence and pelvic pain). Patients and Methods: 51 female patients with a mean age of 55 years were enrolled in the study. The patients presented with the following symptoms: Frequency/urgency 26 patients (50.98%), urge incontinence 22 (43.13%) and interstitial cystitis 3 patients (5.88%). The technique consists in administering low voltage electric stimulation via a 3–5 cm needle placed above the tibial malleolus. Patients received weekly stimulations of 30 minutes for a 10-week period. Quality of life questionnaires and voiding diaries before and after treatment were completed. Moreover, the results were evaluated by patients. The variables analysed include: daytime and nighttime voiding frequency, daytime and nighttime voiding volume, daytime and nighttime leakage episodes and hypogastric pain. Results: A statistically significant improvement was seen in all variables, especially remarkable in relation to frequency/urgency, impact on women quality of life and hypogastric pain, being less marked in relation to leakage episodes and voiding volume. Conclusions: Afferent nerve stimulation offers an alternative treatment for managing lower urinary tract irritative symptoms. However, it would be advisable to confirm the results obtained by means of long-term randomized, follow-up studies. # 2003 Elsevier B.V. All rights reserved. Keywords: Incontinence; Bladder overactivity; Tibial nerve; Transcutaneous electric nerve stimulation 1. Introduction For thousands of years acupuncture has played a key role in traditional Chinese medicine. This technique has been used in the treatment of lower urinary tract dysfunctions such as enuresis, incontinence, frequency, urgency, dysuria and retention of urine, by acting on the so-called S6 region located in the posterior border of the tibia, some 5 cm above the tibial malleolus. Electroacupuncture is a technique consisting in the administration of short electric stimuli via needles *
Corresponding author. Tel. þ34-667481852. E-mail address: [email protected] (B. Congregado Ruiz).
which are placed in precise parts of the body, in order to modify certain physiological or pathological mechanisms. The knowledge of the afferent nerves going from the posterior tibial nerve to the sacral center of micturation has facilitated the invention of the ‘‘PTNS’’ method (Percutaneous Tibial Nerve Stimulation) for managing the lower urinary tract dysfunction, which includes symptoms such as incontinence, urgency, frequency and pelvic pain. The present study analyses the results obtained in those patients who have been treated in our Department with this method from September 1999 through March 2002.
0302-2838/$ – see front matter # 2003 Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2003.08.012
66
B. Congregado Ruiz et al. / European Urology 45 (2004) 65–69
2. Patients and methods From September 1999 through March 2002, 51 female patients suffering from lower urinary tract dysfunction and who had not responded to other conservative therapies (anti-cholinergic drugs), were treated with this method. The mean age of the patients was 55 years (range 18–74) with a deviation of 12 years. The inclusion criteria were:
At least 18 years of age. Sterile urine culture: No active cystitis or urethritis. No previous history of continence surgery No history of current bladder malignancy, high-grade dysplasia or carcinoma No response to anti-cholinergic drugs. The baseline visit includes [1,2]: History: duration of genitourinary symptoms, previous surgical procedures, radiations, medical conditions, medications, mental status, environmental issues, patient mobility,. . . Assessment of symptoms: voiding diary Quality of life questionnaire Physical examination: abdominal, perineal, rectal, vaginal, external genitalia, neurological examination. Urinalysis Standard biochemical test for renal function Estimation of post void residual urine (Ultrasound) Urodynamic evaluation Almost all patients underwent urodynamic workup before treatment (filling cistometry, voiding cistometry, pressure-flow studies, uroflowmetry, residual urine measurement, electromiography). Four patients refused urodinamic study. Voiding diaries and quality of life questionnaires were also completed before, during and after the study. The results were evaluated by patients. Clinical diagnoses were as follows: frequency-urgency 26 patients (50.98%), urge incontinence 22 (43.13%) and interstitial cystitis (diagnosis made according to internationally accepted criteria) 3 (5.88%) [3]. Urodynamic findings (Urodynamic Classification of Lower Urinary Tract Dysfunction, 2nd International Consultation on Incontinence, 2001) [4] revealed: Hypersensitive bladder in 17 patients (33.3%), detrusor overactivity in 15 (25.56%), normal findings in 13 (25.4%), underactive detrusor in 2 (3.9%) and absence of urodynamic study (refusal) in 4 patients (7.84%). The technique employed consists in inserting a 0.22 mm needle about 5 cm above the medial tibial malleolus. The needle is connected to an electric generator producing external pulses of 0 to 10 mA and which increase progressively until the flexor muscle
Fig. 1. The technique consists in inserting a needle about 5 cm above the medial tibial malleolus. The 0.22 mm needle is connected to an electric generator producing external pulses. The voltage remains 1 point bellow the stimulus which generates the muscular contraction.
of the 1st toe is contracted. The voltage remains 1 point bellow the stimulus which generates the muscular contraction (Fig. 1). The treatment is administered weekly for a 30-minute period during 10 weeks. The variables studied include: daytime and nighttime voiding frequency, daytime and nighttime incontinence, daytime and nighttime voiding volume and suprapelvic (hypogastric) pain. These variables are recorded in the data capture forms (standard voiding diary as recommended by ICS guidelines) which are completed before, during and after the study. The mean follow-up was 21 months (range 6–36). This is an analytic observational prospective follow-up study and the results obtained were analysed using the R-sigma statistical software package.
3. Results The variables of daytime and nighttime frequency, voiding volume, daytime and nighttime leakage episodes and hypogastric pain are shown in Table 1. A statistically and clinically significant difference ( p < 0:001) is observed when analysing both daytime and nighttime voiding frequency before and after treatment. Such difference ( p < 0:001) is again seen after the analysis of the changes observed in voiding volume before and after treatment.
Table 1 Frequency, voiding volume, leakage episodes and hypogastric pain are represented Variable
Before treatment
Daytime frequency Daytime voiding volume Daytime leakage episodes Nighttime frequency Nighttime voiding volume Nighttime leakage episodes Hypogastric pain
9.2 138 2.1 2.9 184 0.7 21
5 (3–17) 65 (30–300) 3.1 (0–16) 2.2 (0–9) 123 (0–500) 1.5 (0–8) (100%)
After treatment 6.7 220 0.8 1.4 235 0.2 7
2.5 (3–17) 77 (50–400) 1.5 (0–6) 1.1 (0–4) 157 (0–900) 0.6 (0–3) (33%)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
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Table 2 26 women with frequency or urgency Variable
Before treatment
Daytime frequency Daytime voiding volume Nighttime frequency Nighttime voiding volume Hypogastric pain
9.6 148 2.9 198 11
2.8 (5–15) 58 (50–300) 2.0 (0–9) 128 (0–500) (100%)
After treatment 6.5 231 1.4 234 4
2.0 (4–12) 71 (150–400) 1.0 (0–4) 105 (0–400) (36.3%)
p <0.001 <0.001 <0.001 not significant <0.05
Table 3 22 Patients with incontinence Variable
Before treatment
Daytime frequency Daytime voiding volume Daytime leakage episodes Nighttime frequency Nighttime voiding volume Nighttime leakage episodes Hypogastric pain
8.7 133 3.7 2.5 193 1.2 6
4.3 (3–17) 72 (30–250) 3.6 (0–16) 2.1 (0–8) 122 (0–400) 1.8 (0–8) (100%)
As regards leakage episodes, we observed that though the difference before and after treatment was statistically significant ( p < 0:001), the reduction in the number of episodes is not probably remarkable from a clinical point of view. The relief of hypogastric pain is remarkable, since it decreased in one third of patients suffering from it. The statistical analysis resulted in p < 0:001. As regards the impact of the disease on the quality of life of women, 4 patients (7.8%) felt unhappy before the treatment, 42 patients felt bad (82.35%), 5 patients felt indifferent (9.80%), but none of them felt happy or pleased. After treatment, none of the patients felt unhappy, 9 felt bad (17.6%), 13 felt indifferent (25.4%), 23 felt happy (45.09%) and 6 felt pleased (11.76%) ( p < 0:05). 8 patients evaluated the results as excellent (15.68%), 27 as favourable (52.94%), 9 as fair (17.64%) and 7 found no difference (13.72%). A subgroup of 26 women presented with frequency or urgency, but not with incontinence. Their results are shown in Table 2. As regards the impact of the disease, before treatment 23 women (88.4%) felt bad and 3 (11.53%) felt indifferent. After treatment, 3 women (11.53%) felt bad, 5 (9.80%) felt indifferent, 16 (61.53%) felt happy and 2 (3.92%) felt pleased ( p < 0:05). 3 patients evaluated the results obtained as excellent (11.53%), 17 as favourable (33.3%), 4 as fair (7.84%) and 2 found no difference (7.69%). Another subgroup of 22 patients presented with urge incontinence. Their results are shown in Table 3.
After treatment 7.1 218 1.7 1.3 272 0.4 2
3.2 (4–17) 88 (50–400) 2.0 (0–6) 1.3 (0–4) 210 (0–900) 0.8 (0–3) (33.3%)
p <0.05 <0.001 <0.01 <0.05 not significant <0.01 <0.05
With respect to the impact of the disease, 3 patients felt unhappy (13.63%), 17 felt bad (77.27%) and 2 felt indifferent (9.09%). After treatment 5 patients felt bad (22.72%), 5 felt indifferent (22.72%), 9 felt happy (17.64%) and 3 felt pleased (13.63%) ( p < 0:05). The evaluation of the results was as follows: 4 patients considered them excellent (18.18%), 8 as favourable (36.36%), 5 as fair (22.7%) and 5 patients found no difference (22.72%). No infections, mechanism failures or pain have been detected when using the technique.
4. Discussion The benefitial effects of acupuncture on symptoms such as frequency, urgency and dysuria have been proved by different studies which compare the action on the already mentioned S6 (posterior border of the tibia, 5 cm above the tibial malleolus) traditionally known for its usefulness in the treatment of lower urinary tract dysfunctions, with the use of the technique in other parts of the body obtaining no symptom relief [5]. These preliminary studies led the way to electroacupuncture which consists in the administration of short electric stimuli via needles placed in different parts of the body. However, even nowadays the true effects of electroacupuncture on the central nervous system and its functioning are not known. Different experimental studies have proved that the lower urinary tract stimulation by means of a toxic
68
B. Congregado Ruiz et al. / European Urology 45 (2004) 65–69
agent induces the expression of the fos protein in the spinal centres of micturation. The expression of the oncogene c-fos is one of the first molecular phenomenon caused by the damage in a peripheral nerve. The fos protein acts as a transcription factor and may stimulate the expression of the genes involved in nerve regeneration. Electroacupuncture reduces the expression of such protein in the spinal centres of micturation, which suggests a relationship between electroacupuncture and the modulation of the cellular activity of the spinal cord neurones [6,7]. For years it has been considered that the electric stimulation of the anal sphincter provokes a contraction of the pelvic floor muscles and simultaneously inhibits vesical contractions, stimulating both response mechanisms through the spinal centres of micturation [8,9]. With this information in mind, transrectal and transvaginal stimulation have been used, obtaining different results but causing certain amount of inconvenience to patients. Subsequently, taking into account that the nerves which control the bladder come from the sacral region and that the stimulation of this region provokes neuromodulating effects on the bladder, sacral stimulators have been used with significant results, but requiring surgery to be implanted with certain complications. The knowledge of the afferent nerves going from the posterior tibial nerve to the sacral centre of micturation facilitated the invention of the PTNS method (Percutaneous Tibial Nerve Stimulation) for managing the lower urinary tract dysfunction, which includes symptoms such as incontinence, urgency, frequency and pelvic pain [10]. We have assessed that the results obtained after administering the method to our patients coincide with those reported by other authors. Klinger administers this technique to 15 patients who undergo urodynamic workup and observes an improvement in bladder instability (urodynamic evidence of bladder instability, evident in all patients, was eliminated in 76.9% of them after treatment), voiding frequency and bladder capacity. Moreover, pain is reduced over a mean follow-up period of 10 months [11]. Van Balken studies 37 patients with bladder overactivity and 12 patients presenting with nonobstructive
urinary retention. He obtains a positive response in 60% of all patients, which is significant as regards leakage episodes, and number of pads used, voiding frequency and nocturia. Improvements were also observed in patients with nonobstructive urinary retention, including number of catheterizations, volume catheterized and total volume voided [12]. The results reported by Mazo in a series of 18 patients coincide with those obtained by other authors [13]. The greatest sample so far studied is found in a multicentre study conducted by Govier, which includes 53 patients of 5 different hospitals. According to his results, more than 50% of the patients treated showed a reduction of at least 25% in mean daytime voiding frequency and includes respondent patients enrolled in a programme of chronic treatment or in a progressive reduction protocol [14]. All the studies report a significant improvement of the quality of life o patients and the results confirm the necessity of conducting further long-term randomized, follow-up studies.
5. Conclusions Statistically significant differences are observed when analysing all variables. Differences are probably clinically significant especially in relation to voiding frequency and less significant as regards daytime and nighttime voiding volume. Pain decreases in one third of patients. The treatment lacks efficacy in relation to leakage episodes. There is also statistically and clinically significant difference in relation to the impact of the disease on the life of women. Therefore, we must conclude that the electrostimulation of the posterior tibial nerve significantly improves urgency and frequency, but not incontinence. These results together with the scarce morbidity of this method makes it an effective alternative in the treatment of the symptoms of the lower urinary tract dysfunction. However, long-term randomized, followup studies are necessary to confirm these preliminary impressions.
References [1] Abrams P, Andersson KE, Artibani W, Brubaker L, Cardozo L, Castro D, et al., Recommendations of the international scientific committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence. In: Abrams P, Cardozo L, Khoury S, Wein A,
editors. Incontinence. 2nd International Consultation on Incontinence. July 1–3, 2001. Plymouth: Plymbridge Distributors; 2002. [2] Castro D, Garat JM, Jime´ nez M, Martı´nez E, Pena XM, Rioja C. et al. Pautas de actuacio´ n en incontinencia urinaria femenina. In: Pautas de
B. Congregado Ruiz et al. / European Urology 45 (2004) 65–69
[3] [4]
[5] [6]
[7]
[8]
actuacio´ n en la incontinencia urinaria del Consejo de Salud Vesical. Madrid: Asociacio´ n Espan˜ ola de Urologı´a; 2001. Hanno P, Levin RM, Monson FC, Teuscher C, Zhou ZZ, Ruggieri M, et al. Diagnosis of Interstitial Cystitis. J Urol 1990;143:278. Homma Y, Batista J, Bauer S, Griffiths D, Hilton P, Kramer G, et al. Urodynamics. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence. 2nd International Consultation on Incontinence. July 1–3, 2001. Plymouth: Plymbridge Distributors; 2002. Chang PL. Urodinamic studies in acupuncture for women with frecuency, urgency and dysuria. J Urol 1988;140:563–6. Chang CJ, Huang S-T, Hsu K, Lin A, Stoller ML, Lue TF. Electroacupuncture decreases c-fos expression in the spinal cord induced by noxious stimulation of the rat bladder. J Urol 1998;160: 2274–9. Hunt SP, Pini A, Evan G. Induction of c-fos-like protein in spinal cord neurons following sensory stimulation. Nature 1987;328: 632–4. Godec C, Cass AS, Ayala GF. Bladder inhibition with functional electrical stimulation. Urology 1975;6:663–6.
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[9] McGuire E, Shi-Chun Z, Horwinski E, Lytton B. Treatment of motor and sensory detrusor instability by electrical stimulation. J Urol 1983;129:78–9. [10] Bemelmans BLH. Neuromodulation by Interstim and PercSans for treating lower urinary tract symptoms and dysfunction. Urol Integr Invest 2001;6(3):198–206. [11] Klingler HC, Pycha A, Schmidbauer J, Marberger M. The use of peripheral neuromodulation of the S3 region for treatment of detrusor overactivity: an urodinamic based study. Urology 2000;56(5):766–71. [12] Van Balken MR, Vandoninck V, Gisolf KW, Vergunst H, Kiemeney LA, Debruyne FM, et al. Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. J Urol 2001;166(3):914–8. [13] Mazo EB, Krivoborodov GG. Temporary sacral and tibial neuromodulation in treating patients with overactive urinary bladder. Zh Vopr Neirokhir Im N N Burdenko 2002;2002(1):17–21. [14] Govier F, Litwiller S, Nitti V, Kreder K, Roserblatt P. Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study. J Urol 2001;165(4):1193–8.
European Urology 45 (2004) 65–69
Peripheral Afferent Nerve Stimulation forTreatment of Lower UrinaryTract Irritative Symptoms B. Congregado Ruiz*, X.M. Pena Outeirin˜o, P. Campoy Martı´nez, E. Leo´n Duen˜as, A. Leal Lo´pez Servicio de Urologı´a, Hospital Universitario Virgen del Rocı´o, Manuel Siurot S/N, 41012 Sevilla, Spain Accepted 28 August 2003 Published online 2 October 2003
Abstract Objectives: To assess the efficacy of posterior tibial nerve stimulation for treatment of lower urinary tract irritative symptoms (urgency, frequency, urge incontinence and pelvic pain). Patients and Methods: 51 female patients with a mean age of 55 years were enrolled in the study. The patients presented with the following symptoms: Frequency/urgency 26 patients (50.98%), urge incontinence 22 (43.13%) and interstitial cystitis 3 patients (5.88%). The technique consists in administering low voltage electric stimulation via a 3–5 cm needle placed above the tibial malleolus. Patients received weekly stimulations of 30 minutes for a 10-week period. Quality of life questionnaires and voiding diaries before and after treatment were completed. Moreover, the results were evaluated by patients. The variables analysed include: daytime and nighttime voiding frequency, daytime and nighttime voiding volume, daytime and nighttime leakage episodes and hypogastric pain. Results: A statistically significant improvement was seen in all variables, especially remarkable in relation to frequency/urgency, impact on women quality of life and hypogastric pain, being less marked in relation to leakage episodes and voiding volume. Conclusions: Afferent nerve stimulation offers an alternative treatment for managing lower urinary tract irritative symptoms. However, it would be advisable to confirm the results obtained by means of long-term randomized, follow-up studies. # 2003 Elsevier B.V. All rights reserved. Keywords: Incontinence; Bladder overactivity; Tibial nerve; Transcutaneous electric nerve stimulation 1. Introduction For thousands of years acupuncture has played a key role in traditional Chinese medicine. This technique has been used in the treatment of lower urinary tract dysfunctions such as enuresis, incontinence, frequency, urgency, dysuria and retention of urine, by acting on the so-called S6 region located in the posterior border of the tibia, some 5 cm above the tibial malleolus. Electroacupuncture is a technique consisting in the administration of short electric stimuli via needles *
Corresponding author. Tel. þ34-667481852. E-mail address: [email protected] (B. Congregado Ruiz).
which are placed in precise parts of the body, in order to modify certain physiological or pathological mechanisms. The knowledge of the afferent nerves going from the posterior tibial nerve to the sacral center of micturation has facilitated the invention of the ‘‘PTNS’’ method (Percutaneous Tibial Nerve Stimulation) for managing the lower urinary tract dysfunction, which includes symptoms such as incontinence, urgency, frequency and pelvic pain. The present study analyses the results obtained in those patients who have been treated in our Department with this method from September 1999 through March 2002.
0302-2838/$ – see front matter # 2003 Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2003.08.012
66
B. Congregado Ruiz et al. / European Urology 45 (2004) 65–69
2. Patients and methods From September 1999 through March 2002, 51 female patients suffering from lower urinary tract dysfunction and who had not responded to other conservative therapies (anti-cholinergic drugs), were treated with this method. The mean age of the patients was 55 years (range 18–74) with a deviation of 12 years. The inclusion criteria were:
At least 18 years of age. Sterile urine culture: No active cystitis or urethritis. No previous history of continence surgery No history of current bladder malignancy, high-grade dysplasia or carcinoma No response to anti-cholinergic drugs. The baseline visit includes [1,2]: History: duration of genitourinary symptoms, previous surgical procedures, radiations, medical conditions, medications, mental status, environmental issues, patient mobility,. . . Assessment of symptoms: voiding diary Quality of life questionnaire Physical examination: abdominal, perineal, rectal, vaginal, external genitalia, neurological examination. Urinalysis Standard biochemical test for renal function Estimation of post void residual urine (Ultrasound) Urodynamic evaluation Almost all patients underwent urodynamic workup before treatment (filling cistometry, voiding cistometry, pressure-flow studies, uroflowmetry, residual urine measurement, electromiography). Four patients refused urodinamic study. Voiding diaries and quality of life questionnaires were also completed before, during and after the study. The results were evaluated by patients. Clinical diagnoses were as follows: frequency-urgency 26 patients (50.98%), urge incontinence 22 (43.13%) and interstitial cystitis (diagnosis made according to internationally accepted criteria) 3 (5.88%) [3]. Urodynamic findings (Urodynamic Classification of Lower Urinary Tract Dysfunction, 2nd International Consultation on Incontinence, 2001) [4] revealed: Hypersensitive bladder in 17 patients (33.3%), detrusor overactivity in 15 (25.56%), normal findings in 13 (25.4%), underactive detrusor in 2 (3.9%) and absence of urodynamic study (refusal) in 4 patients (7.84%). The technique employed consists in inserting a 0.22 mm needle about 5 cm above the medial tibial malleolus. The needle is connected to an electric generator producing external pulses of 0 to 10 mA and which increase progressively until the flexor muscle
Fig. 1. The technique consists in inserting a needle about 5 cm above the medial tibial malleolus. The 0.22 mm needle is connected to an electric generator producing external pulses. The voltage remains 1 point bellow the stimulus which generates the muscular contraction.
of the 1st toe is contracted. The voltage remains 1 point bellow the stimulus which generates the muscular contraction (Fig. 1). The treatment is administered weekly for a 30-minute period during 10 weeks. The variables studied include: daytime and nighttime voiding frequency, daytime and nighttime incontinence, daytime and nighttime voiding volume and suprapelvic (hypogastric) pain. These variables are recorded in the data capture forms (standard voiding diary as recommended by ICS guidelines) which are completed before, during and after the study. The mean follow-up was 21 months (range 6–36). This is an analytic observational prospective follow-up study and the results obtained were analysed using the R-sigma statistical software package.
3. Results The variables of daytime and nighttime frequency, voiding volume, daytime and nighttime leakage episodes and hypogastric pain are shown in Table 1. A statistically and clinically significant difference ( p < 0:001) is observed when analysing both daytime and nighttime voiding frequency before and after treatment. Such difference ( p < 0:001) is again seen after the analysis of the changes observed in voiding volume before and after treatment.
Table 1 Frequency, voiding volume, leakage episodes and hypogastric pain are represented Variable
Before treatment
Daytime frequency Daytime voiding volume Daytime leakage episodes Nighttime frequency Nighttime voiding volume Nighttime leakage episodes Hypogastric pain
9.2 138 2.1 2.9 184 0.7 21
5 (3–17) 65 (30–300) 3.1 (0–16) 2.2 (0–9) 123 (0–500) 1.5 (0–8) (100%)
After treatment 6.7 220 0.8 1.4 235 0.2 7
2.5 (3–17) 77 (50–400) 1.5 (0–6) 1.1 (0–4) 157 (0–900) 0.6 (0–3) (33%)
p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001
B. Congregado Ruiz et al. / European Urology 45 (2004) 65–69
67
Table 2 26 women with frequency or urgency Variable
Before treatment
Daytime frequency Daytime voiding volume Nighttime frequency Nighttime voiding volume Hypogastric pain
9.6 148 2.9 198 11
2.8 (5–15) 58 (50–300) 2.0 (0–9) 128 (0–500) (100%)
After treatment 6.5 231 1.4 234 4
2.0 (4–12) 71 (150–400) 1.0 (0–4) 105 (0–400) (36.3%)
p <0.001 <0.001 <0.001 not significant <0.05
Table 3 22 Patients with incontinence Variable
Before treatment
Daytime frequency Daytime voiding volume Daytime leakage episodes Nighttime frequency Nighttime voiding volume Nighttime leakage episodes Hypogastric pain
8.7 133 3.7 2.5 193 1.2 6
4.3 (3–17) 72 (30–250) 3.6 (0–16) 2.1 (0–8) 122 (0–400) 1.8 (0–8) (100%)
As regards leakage episodes, we observed that though the difference before and after treatment was statistically significant ( p < 0:001), the reduction in the number of episodes is not probably remarkable from a clinical point of view. The relief of hypogastric pain is remarkable, since it decreased in one third of patients suffering from it. The statistical analysis resulted in p < 0:001. As regards the impact of the disease on the quality of life of women, 4 patients (7.8%) felt unhappy before the treatment, 42 patients felt bad (82.35%), 5 patients felt indifferent (9.80%), but none of them felt happy or pleased. After treatment, none of the patients felt unhappy, 9 felt bad (17.6%), 13 felt indifferent (25.4%), 23 felt happy (45.09%) and 6 felt pleased (11.76%) ( p < 0:05). 8 patients evaluated the results as excellent (15.68%), 27 as favourable (52.94%), 9 as fair (17.64%) and 7 found no difference (13.72%). A subgroup of 26 women presented with frequency or urgency, but not with incontinence. Their results are shown in Table 2. As regards the impact of the disease, before treatment 23 women (88.4%) felt bad and 3 (11.53%) felt indifferent. After treatment, 3 women (11.53%) felt bad, 5 (9.80%) felt indifferent, 16 (61.53%) felt happy and 2 (3.92%) felt pleased ( p < 0:05). 3 patients evaluated the results obtained as excellent (11.53%), 17 as favourable (33.3%), 4 as fair (7.84%) and 2 found no difference (7.69%). Another subgroup of 22 patients presented with urge incontinence. Their results are shown in Table 3.
After treatment 7.1 218 1.7 1.3 272 0.4 2
3.2 (4–17) 88 (50–400) 2.0 (0–6) 1.3 (0–4) 210 (0–900) 0.8 (0–3) (33.3%)
p <0.05 <0.001 <0.01 <0.05 not significant <0.01 <0.05
With respect to the impact of the disease, 3 patients felt unhappy (13.63%), 17 felt bad (77.27%) and 2 felt indifferent (9.09%). After treatment 5 patients felt bad (22.72%), 5 felt indifferent (22.72%), 9 felt happy (17.64%) and 3 felt pleased (13.63%) ( p < 0:05). The evaluation of the results was as follows: 4 patients considered them excellent (18.18%), 8 as favourable (36.36%), 5 as fair (22.7%) and 5 patients found no difference (22.72%). No infections, mechanism failures or pain have been detected when using the technique.
4. Discussion The benefitial effects of acupuncture on symptoms such as frequency, urgency and dysuria have been proved by different studies which compare the action on the already mentioned S6 (posterior border of the tibia, 5 cm above the tibial malleolus) traditionally known for its usefulness in the treatment of lower urinary tract dysfunctions, with the use of the technique in other parts of the body obtaining no symptom relief [5]. These preliminary studies led the way to electroacupuncture which consists in the administration of short electric stimuli via needles placed in different parts of the body. However, even nowadays the true effects of electroacupuncture on the central nervous system and its functioning are not known. Different experimental studies have proved that the lower urinary tract stimulation by means of a toxic
68
B. Congregado Ruiz et al. / European Urology 45 (2004) 65–69
agent induces the expression of the fos protein in the spinal centres of micturation. The expression of the oncogene c-fos is one of the first molecular phenomenon caused by the damage in a peripheral nerve. The fos protein acts as a transcription factor and may stimulate the expression of the genes involved in nerve regeneration. Electroacupuncture reduces the expression of such protein in the spinal centres of micturation, which suggests a relationship between electroacupuncture and the modulation of the cellular activity of the spinal cord neurones [6,7]. For years it has been considered that the electric stimulation of the anal sphincter provokes a contraction of the pelvic floor muscles and simultaneously inhibits vesical contractions, stimulating both response mechanisms through the spinal centres of micturation [8,9]. With this information in mind, transrectal and transvaginal stimulation have been used, obtaining different results but causing certain amount of inconvenience to patients. Subsequently, taking into account that the nerves which control the bladder come from the sacral region and that the stimulation of this region provokes neuromodulating effects on the bladder, sacral stimulators have been used with significant results, but requiring surgery to be implanted with certain complications. The knowledge of the afferent nerves going from the posterior tibial nerve to the sacral centre of micturation facilitated the invention of the PTNS method (Percutaneous Tibial Nerve Stimulation) for managing the lower urinary tract dysfunction, which includes symptoms such as incontinence, urgency, frequency and pelvic pain [10]. We have assessed that the results obtained after administering the method to our patients coincide with those reported by other authors. Klinger administers this technique to 15 patients who undergo urodynamic workup and observes an improvement in bladder instability (urodynamic evidence of bladder instability, evident in all patients, was eliminated in 76.9% of them after treatment), voiding frequency and bladder capacity. Moreover, pain is reduced over a mean follow-up period of 10 months [11]. Van Balken studies 37 patients with bladder overactivity and 12 patients presenting with nonobstructive
urinary retention. He obtains a positive response in 60% of all patients, which is significant as regards leakage episodes, and number of pads used, voiding frequency and nocturia. Improvements were also observed in patients with nonobstructive urinary retention, including number of catheterizations, volume catheterized and total volume voided [12]. The results reported by Mazo in a series of 18 patients coincide with those obtained by other authors [13]. The greatest sample so far studied is found in a multicentre study conducted by Govier, which includes 53 patients of 5 different hospitals. According to his results, more than 50% of the patients treated showed a reduction of at least 25% in mean daytime voiding frequency and includes respondent patients enrolled in a programme of chronic treatment or in a progressive reduction protocol [14]. All the studies report a significant improvement of the quality of life o patients and the results confirm the necessity of conducting further long-term randomized, follow-up studies.
5. Conclusions Statistically significant differences are observed when analysing all variables. Differences are probably clinically significant especially in relation to voiding frequency and less significant as regards daytime and nighttime voiding volume. Pain decreases in one third of patients. The treatment lacks efficacy in relation to leakage episodes. There is also statistically and clinically significant difference in relation to the impact of the disease on the life of women. Therefore, we must conclude that the electrostimulation of the posterior tibial nerve significantly improves urgency and frequency, but not incontinence. These results together with the scarce morbidity of this method makes it an effective alternative in the treatment of the symptoms of the lower urinary tract dysfunction. However, long-term randomized, followup studies are necessary to confirm these preliminary impressions.
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