- Email: [email protected]
The Effect of Biofeedback Physical Therapy in Men with Chronic Pelvic Pain Syndrome Type III
European Urology
European Urology 47 (2005) 607–611
The Effect of Biofeedback Physical Therapy in Men with Chronic Pelvic Pain SyndromeType III Erik B. Cornela,*, Ernst P. van Haarstb, Ria W.M. Browning-Groote Schaarsbergc, Jenet Geelsc a
Department of Urology, Ziekenhuis Groep Twente location SMT, P.O. Box 546, 7550 AM Hengelo, The Netherlands Department of Urology, Sint Lucas Andreas Ziekenhuis, Amsterdam, The Netherlands c Department of Physical Therapy, Ziekenhuis Groep Twente location SMT, Hengelo, The Netherlands b
Accepted 20 December 2004 Available online 5 January 2005
Abstract Recent studies suggest that the symptoms of chronic non-bacterial prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS) may be due to or associated with pelvic floor muscle dysfunction. Therapies aimed to improve relaxation and proper use of the pelvic floor muscles such as biofeedback physical therapy and pelvic floor reeducation are expected to give symptom improvement. The objective of this study was to evaluate the effect of biofeedback physical therapy on the symptoms of men with CPPS. Materials and Methods: Between March 2000 to March 2004, 33 consecutive men were diagnosed with CP/CPPS based on history including the NIH-CPSI questionnaire and physical examination including pelvic floor muscle tonus, urinalysis, uroflowmetry with residual urine measurement and transrectal ultrasonography of the prostate. All patients participated in a pelvic floor biofeedback re-educating program. A rectal EMG probe was used to measure resting tone of the pelvic floor muscles and was helpful for instruction pelvic floor muscles contraction and relaxation. Results: Two of the 33 men dropped out. In the remaining 31 men, mean age 43.9 years (range 23–70), the mean total Chronic Prostatitis Symptom Index (NIH-CPSI) changed from 23.6 (range 11–34) at baseline to 11.4 (range 1– 25) after treatment (p < 0.001). The mean value of the pelvic floor muscle tonus was 4.9 at diagnosis (range 2.0– 10.0) and decreased to 1.7 (range 0.5–2.8) after treatment (p < 0.001). Conclusions: Our study clearly demonstrates a significant effect of biofeedback physical therapy and pelvic floor reeducation for CP/CPPS patients, leading to a significant improvement of the symptom score. The correlation between the pelvic muscle tonus results with NIH-CPSI score is highly suggestive that the pelvic floor plays an important role in the pathophysiology of CP/CPPS. # 2004 Elsevier B.V. All rights reserved. Keywords: Chronic pelvic pain syndrome type III; Biofeedback physical therapy; Prostate
1. Introduction Chronic Pelvic Pain Syndrome type III or chronic non-bacterial prostatitis (CP/CPPS) is characterized by Lower Urinary Tract Symptoms (LUTS), discomfort or pain in the pelvic region for at least 3 months of duration and sexual dysfunction [1]. Over the last decade this benign entity has attracted much attention * Corresponding author. Fax +31 74 2475264. E-mail address: [email protected] (E.B. Cornel).
due to the high prevalence, socio-economic impact and severe impact on the quality of life of a CP/CPPS patient [1,2]. However, knowledge about the etiology, the pathophysiology and proper therapy for CP/CPPS is still lacking. In 1995 the National Institutes of Health (NIH) described the development and validation of the Chronic Prostatitis Symptom Index (NIH-CPSI) [3]. This index addressed the 3 most important domains of CP/CPPS: pain (location, severity and frequency), voiding (irritative and obstructive symptoms), and
0302-2838/$ – see front matter # 2004 Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2004.12.014
608
E.B. Cornel et al. / European Urology 47 (2005) 607–611
impact/quality of life. Although the diagnosis of CP/ CPPS is primarily a diagnosis of exclusion, the NIHCPSI has proven to be of value for the diagnosis and follow-up treatment, even in primary and secondary care, of these patients [4]. The treatment of men with CP/CPPS is difficult because the pathogenesis is unclear. Several treatment modalities such as antimicrobial agents, analgesics, anti-inflammatory agents, muscle relaxants, alphablockers, 5-alpha-reductase inhibitors, heat therapy, surgery and biofeedback physical therapy have been proposed and investigated [5]. Since pathogenic bacteria present in the prostate do not cause CP/CPPS unless an acute urinary tract infection develops, the rationale for antibiotics for the treatment of CP/CPPS is missing [6,7]. Alpha-blockade has proven beneficial in a subset of patients with mainly obstructive LUTS [8,9]. Finally, based on the hypothesis of Segura et al. that CP/CPPS may be the result of or associated with pelvic floor abnormalities, Zermann demonstrated that the majority of patients with CP/CPPS had pathological tenderness of the striated pelvic floor muscles and poor to absent pelvic floor function [10,11]. Indeed, a recent case control study demonstrated that men with CP/CPPS have significantly more abnormal pelvic floor muscular findings compared with a group of men without pain [12]. Based on these findings treatment of men with CP/CPPS with biofeedback physical therapy may be meaningful. In combination with electromyografical measure for biofeedback training, skeletal muscle activity can be measured and used for diagnosis or used as a cue for patient education. Here we report our experience with biofeedback physical therapy as primary treatment of men with CP/CPPS. 2. Methods Between March 2000 to March 2004, 33 consecutive men (mean age 45 years, range from 23 years to 70 years) who were diagnosed with CP/CPPS participated in a pelvic floor biofeedback re-education program. Diagnosis was based on history including the NIH-CPSI questionnaire and physical examination including pelvic floor muscle tonus (piriform, coccygeal, levator ani and obdurator muscles), urinalysis, uroflowmetry with residual urine measurement and transrectal ultrasonography of the prostate. Inclusion criteria included age more than 18 years, pelvic pain or discomfort for at least 3 months, NIH-CPSI greater than 15. Exclusion criteria were urinary tract infections in the past 6 months, a history of cancer, any neurological disorders, and transurethral procedures in a patient’s history. Each patient received individual treatment by a pelvic floor physical therapist, initially once a week and later on once every 2–4 weeks, depending on the progress made. The first session included paramedical anamnese, inspection of position, locomotion, mobi-
lity and breathing technique. Additionally, patients were familiarized with the anatomy and physiology of the pelvic organs and muscles using appropriate photographs and anatomical models. During the second treatment session the first exercise instructions were given and palpation of the pelvic floor muscles was performed. During the third session biofeedback measurements were performed and relaxation exercises started. A one-channel electromyography (EMG) biofeedback apparatus (Pelvined 932, EnrafNonius, the Netherlands) was used for EMG measurements. An EMG probe was placed in the anal canal in order to measure resting tone and strength of the levator ani muscle. Patients were taught in detail how to relax and constrict their pelvic floor muscles. The patient was placed in supine position with bended legs and asked to ‘‘hold back bowel movements or passing gas’’. Verbal guidance and feedback through palpation of the pelvic floor muscles and biofeedback measurements were used to teach how to correctly contract and relax the pelvic floor muscles. During the following sessions the exercises were designed to further relax and coordinate the pelvic floor muscles. Initially the exercises were performed while in supine position but later when sitting, standing and during daily activities. The NIH-CPSI total score, being a reliable and responsive measure of prostatitis symptoms, was used for the diagnosis and to monitor the effect of therapy. Moreover, pelvic floor muscle tonus measurements were used to complete the diagnosis and to monitor the effect of the biofeedback physical therapy. The therapy was evaluated after 6 to 8 treatment sessions. For statistical analysis the Wilcoxon signed ranks test for paired samples was performed. Where appropriate, Spearman’s correlation coefficient for nonparametric samples was calculated. A probability of less than 5% was defined as significant.
3. Results Two of the 33 men who were diagnosed with CP/ CPPS dropped out. One patient could not be properly trained because he did not understand the instructions. His pelvic floor muscle tonus was elevated and the NIH-CPSI was 21. The other patient stopped training after 3 sessions and did not return for follow up. The remaining 31 men were entered for analysis. The total CPSI score decreased after treatment for all patients except one (97%) (Fig. 1a). In the subdomain of micturition improvement was seen in 25 patients (81%), whereas for the subdomain pain the improvement was seen in 27 patients (87%) (Fig. 1b and c). In the subdomain of quality of life the score improved in 23 patients (74%). Thirteen patients (29%) even improved 5 points or more (Fig. 1d). All men exhibited abnormal anal sfincter tone on physical examination and in the majority of cases the levator ani muscle was most vulnerable. The EMG was performed in all. However, only in 18 patients pre- and post-treatment values were recorded. The post-treatment values decreased in all but one patient, in which it did not change (Fig. 1e). The mean value of the pelvic muscle tonus was 4.9 mV at diag-
E.B. Cornel et al. / European Urology 47 (2005) 607–611
609
Fig. 1. Comparison for all cases of the pre-treatment and post-treatment values. In (a) the CPSI and its subdomains in (b, c and d) In (e) the EMG-values.
610
E.B. Cornel et al. / European Urology 47 (2005) 607–611
Table 1 Results pre- and post-treatment Pre-treatment
NIH-CPSI NIH-CPSI NIH-CPSI NIH-CPSI EMG *
total (0–43) pain (0–21) micturition (0–10) QoL (0–12)
p-value*
Post-treatment
Mean
Range
Mean
Range
23.6 11.0 5.1 7.3 4.8
11–34 2–16 0–10 2–11 2.0–10.0
11.4 5.7 2.2 3.5 1.7
1–25 1–13 0–6 0–10 0.5–2.8
<0.001 <0.001 <0.001 <0.001 <0.001
Change range
2–26 1–10 0–9 2–9 0–7
Wilcoxon signed ranks test for paired samples.
nosis and decreased significantly to 1.7 mV after treatment. Summaries for the whole group are shown in Table 1. Within the total NIH-CPSI score, as well as in its specific subdomains, the decrease is highly significant (Table 1). The decrease has a good correlation with he initial score; i.e. the higher the initial score, the stronger the decrease (total CPSI r = 0.64; pain r = 0.45; micturition r = 0.74; quality of life r = 0.75; p < 0.001 for all). The one patient with an increase in CPSI, also had a one point increase in his pain and in his quality of life score, while his micturition score remained unchanged. On the other side of the spectrum, the patient with the strongest decrease in CPSI of 26 points, also had the highest decrease in his pain score of 10 points, the highest decrease in micturition score of 9 points, and a high decrease in quality of life score of 7 points. In general, there are good correlations between the changes in the total score and the subdomains pain (r = 0.8) and quality of life (r = 0.92), but moderate correlations with the micturition domain (r = 0.44). The correlations between the changes in the domains of pain and of micturition are good (r = 0.72). However, the change in the micturition domain is not correlated to that in the pain or the quality of life domain.
4. Discussion The specific mechanisms underlying the CP/CPPS syndrome have not been defined. Since the last decade some progress has been achieved in the understanding of this benign entity which has a severe impact on the quality of life of a CPPS patient [5,7–9,13]. For the evaluation of new therapies for CP/CPPS the NIHCPSI is considered a reliable and responsive measure of CP/CPPS in primary and secondary care [4]. Until recently, the prostate and bacterial infections were believed to play an important role in the pathophysiology of CP/CPPS [6]. However, it is now well
established that bacteria do not play a significant role in the development of CP/CPPS [7]. Thus far, only a few therapies have shown to be effective in the treatment of the debilitating symptoms of CP/CPPS [8,9,13] Alphablockade, tested in a double blinded randomised trial, showed a significant decrease in the NIH-CPSI score, particularly in the pain domain [8,9]. Uroselective alpha blockade works through the reduction of muscle tonus in the prostate gland, prostate capsule and the region of the bladder neck [14]. Surprisingly, the aforementioned study did not show significant effects on micturition. Segura et al. hypothesized that the muscle tone of the pelvic floor muscles i.e. levator ani and short external rotators may play a prominent role in the pathophysiology of CP [10]. Moreover, they suggest that the symptoms of patients, currently categorized as CP/CPPS, are similar to those having pelvic floor tension myalgia or levator ani syndrome. A recent case control study demonstrated that men with CP/CPPS indeed have significantly more abnormal pelvic floor muscular findings compared to a group of men without pain [12]. Specifically, it may be valuable to investigate the effects of biofeedback physical therapy and pelvic floor reeducation in CP/CPPS patients [13]. The present study clearly demonstrates a significant decrease in mean total NIH-CPSI score of 23.6 at baseline to 11.4 after treatment for all treatable patients. Regarding the specific domains of the NIH-CPSI, a significant decrease was seen in all subdomains. The decrease of the CPSI was highly correlated to decreases in the pain and quality of life domains, but only moderately to the decrease in the micturition domain. Moreover, we clearly demonstrate the benefit of this treatment with a concomitant decrease of the pelvic floor muscle tonus. This decrease further support the hypothesis that increased muscle tonus of the pelvic floor plays a pivotal role in the pathophysiology of CP/CPPS. However, the long-term durability of our outcomes has not yet been investigated. To our opinion the word prostate should be
E.B. Cornel et al. / European Urology 47 (2005) 607–611
omitted describing these symptoms, to avoid a ‘‘prostatocentric approach’’. In a study by Clemens in a group of 19 patients a meaningful improvement of symptoms was achieved in only 33% partially due to a high drop out rate [13]. Moreover, to accurately compare the efficacy of treatments for a given disease process, it is mandatory to have standard outcome measure. In the study performed by Clemens et al. the NIH-CPSI was not used which makes comparison with our results difficult [13]. Although we realize that comparison with a placebo group would have been more appropriate our results with this patient group is suggesting that we have been able to alter their natural disease. However, placebo treatment is impossible because patient participation and training are essential elements that cannot be mimicked by placebo treatment. Moreover, an improvement of up to 60% as a placebo effect, documented in uncontrolled trials assessing antibiotics,
611
pentosan polysulfate and other pharmacological agents, is still far less than the almost 100% improvement seen in our study.
5. Conclusions Our study clearly demonstrates the significant effect of biofeedback physical therapy and pelvic floor reeducation for CP/CPPS patients. The observation that the EMG results correlated with the NIH-CPSI score appears to emphasize that the pelvic floor plays an important role in the pathophysiology of CP/CPPS.
Acknowledgements We would like to thank Dr Egbert Oosterwijk for his critically comments of the manuscript.
References [1] Schaeffer AJ. Classification (traditional and national institutes of health) and demographics of prostatitis. Urology 2002;60:5. [2] Roberts RO, Jacobson DJ, Girman CJ, Rhodes T, Lieber MM, Jacobsen SJ. Prevalence of prostatitis-like symptoms in a community based cohort of older men. J Urol 2002;168:2467. [3] Litwin MS. A review of the development and validation of the national institutes of health chronic prostatitis symptom index. Urology 2002;60(Suppl 6A):14. [4] Turner JA, Ciol MA, von Krof M, Berger R. Validity and responsiveness of the national institutes of health chronic prostatitis symptom index. J Urol 2003;169:580. [5] Curtis Nickel J. Prostatitis: Evolving management strategies. Urological Clinics of North America 1999;26(4):737. [6] Kieger JN, Ross SO, Riley DE. Chronic prostatitis: epidemiology and role of infection. Urology 2002;60(Suppl 6A):8. [7] Lee JC, Muller CH, Rothman I, Agnew J, Eschenbach D, Ciol MA, et al. Prostate biopsy cultures findings of men with chronic pelvic pain syndrome do not differ from those of healthy controls. J Urol 2003; 169:584. [8] Yeong Cheah P, Liong ML, Yuen KH, The CL, Khor T, Yang JR, et al. Terazosin therapy for chronic prostatits/chronic pelvic pain
[9]
[10] [11]
[12]
[13]
[14]
syndrome: a randomized placebo controlled trail. J Urol 2003;169: 592. Mehik A, Alas P, Curtis Nickel J, Sarpola A, Helstro¨ m PJ. Alfuzosin treatment for chronic prostatitis/chronic pelvic pain syndrome: a prospective, randomized, double-blind, placebo-controlled, pilot study. Urology 2003;62:425. Segura JW, Opitz JL, Greene LF. Prostatosis, prostatitis or pelvic floor tension myalgia? J Urol 1979;122:168. Zermann DH, Ishigooka M, Doggweiler R, Schmidt RA. Neurological insights into the etiology of genitourinary pain in men. J Urol 1999;161:903. Hetrick DC, Ciol MA, Rothman I, Turner JA, Frest M, Berger RE. Musculoskeletal dysfunction in men with chronic pelvic pain syndrome type III: a case control study. J Urol 2003;170: 828. Clemens JQ, Nadler RB, Schaeffer AJ, Belani J, Albaugh J, Bushman W. Biofeedback, pelvic floor re-education, and bladder training for male pelvic pain syndrome. Urology 2000;56:951. Roehrborn CG. Alfuzosin: overview of pharmacokinetics, safety, and efficacy of a clinically uroselective alpha-blocker. Urology 2001;58(Suppl 6A):55.
European Urology 47 (2005) 607–611
The Effect of Biofeedback Physical Therapy in Men with Chronic Pelvic Pain SyndromeType III Erik B. Cornela,*, Ernst P. van Haarstb, Ria W.M. Browning-Groote Schaarsbergc, Jenet Geelsc a
Department of Urology, Ziekenhuis Groep Twente location SMT, P.O. Box 546, 7550 AM Hengelo, The Netherlands Department of Urology, Sint Lucas Andreas Ziekenhuis, Amsterdam, The Netherlands c Department of Physical Therapy, Ziekenhuis Groep Twente location SMT, Hengelo, The Netherlands b
Accepted 20 December 2004 Available online 5 January 2005
Abstract Recent studies suggest that the symptoms of chronic non-bacterial prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS) may be due to or associated with pelvic floor muscle dysfunction. Therapies aimed to improve relaxation and proper use of the pelvic floor muscles such as biofeedback physical therapy and pelvic floor reeducation are expected to give symptom improvement. The objective of this study was to evaluate the effect of biofeedback physical therapy on the symptoms of men with CPPS. Materials and Methods: Between March 2000 to March 2004, 33 consecutive men were diagnosed with CP/CPPS based on history including the NIH-CPSI questionnaire and physical examination including pelvic floor muscle tonus, urinalysis, uroflowmetry with residual urine measurement and transrectal ultrasonography of the prostate. All patients participated in a pelvic floor biofeedback re-educating program. A rectal EMG probe was used to measure resting tone of the pelvic floor muscles and was helpful for instruction pelvic floor muscles contraction and relaxation. Results: Two of the 33 men dropped out. In the remaining 31 men, mean age 43.9 years (range 23–70), the mean total Chronic Prostatitis Symptom Index (NIH-CPSI) changed from 23.6 (range 11–34) at baseline to 11.4 (range 1– 25) after treatment (p < 0.001). The mean value of the pelvic floor muscle tonus was 4.9 at diagnosis (range 2.0– 10.0) and decreased to 1.7 (range 0.5–2.8) after treatment (p < 0.001). Conclusions: Our study clearly demonstrates a significant effect of biofeedback physical therapy and pelvic floor reeducation for CP/CPPS patients, leading to a significant improvement of the symptom score. The correlation between the pelvic muscle tonus results with NIH-CPSI score is highly suggestive that the pelvic floor plays an important role in the pathophysiology of CP/CPPS. # 2004 Elsevier B.V. All rights reserved. Keywords: Chronic pelvic pain syndrome type III; Biofeedback physical therapy; Prostate
1. Introduction Chronic Pelvic Pain Syndrome type III or chronic non-bacterial prostatitis (CP/CPPS) is characterized by Lower Urinary Tract Symptoms (LUTS), discomfort or pain in the pelvic region for at least 3 months of duration and sexual dysfunction [1]. Over the last decade this benign entity has attracted much attention * Corresponding author. Fax +31 74 2475264. E-mail address: [email protected] (E.B. Cornel).
due to the high prevalence, socio-economic impact and severe impact on the quality of life of a CP/CPPS patient [1,2]. However, knowledge about the etiology, the pathophysiology and proper therapy for CP/CPPS is still lacking. In 1995 the National Institutes of Health (NIH) described the development and validation of the Chronic Prostatitis Symptom Index (NIH-CPSI) [3]. This index addressed the 3 most important domains of CP/CPPS: pain (location, severity and frequency), voiding (irritative and obstructive symptoms), and
0302-2838/$ – see front matter # 2004 Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2004.12.014
608
E.B. Cornel et al. / European Urology 47 (2005) 607–611
impact/quality of life. Although the diagnosis of CP/ CPPS is primarily a diagnosis of exclusion, the NIHCPSI has proven to be of value for the diagnosis and follow-up treatment, even in primary and secondary care, of these patients [4]. The treatment of men with CP/CPPS is difficult because the pathogenesis is unclear. Several treatment modalities such as antimicrobial agents, analgesics, anti-inflammatory agents, muscle relaxants, alphablockers, 5-alpha-reductase inhibitors, heat therapy, surgery and biofeedback physical therapy have been proposed and investigated [5]. Since pathogenic bacteria present in the prostate do not cause CP/CPPS unless an acute urinary tract infection develops, the rationale for antibiotics for the treatment of CP/CPPS is missing [6,7]. Alpha-blockade has proven beneficial in a subset of patients with mainly obstructive LUTS [8,9]. Finally, based on the hypothesis of Segura et al. that CP/CPPS may be the result of or associated with pelvic floor abnormalities, Zermann demonstrated that the majority of patients with CP/CPPS had pathological tenderness of the striated pelvic floor muscles and poor to absent pelvic floor function [10,11]. Indeed, a recent case control study demonstrated that men with CP/CPPS have significantly more abnormal pelvic floor muscular findings compared with a group of men without pain [12]. Based on these findings treatment of men with CP/CPPS with biofeedback physical therapy may be meaningful. In combination with electromyografical measure for biofeedback training, skeletal muscle activity can be measured and used for diagnosis or used as a cue for patient education. Here we report our experience with biofeedback physical therapy as primary treatment of men with CP/CPPS. 2. Methods Between March 2000 to March 2004, 33 consecutive men (mean age 45 years, range from 23 years to 70 years) who were diagnosed with CP/CPPS participated in a pelvic floor biofeedback re-education program. Diagnosis was based on history including the NIH-CPSI questionnaire and physical examination including pelvic floor muscle tonus (piriform, coccygeal, levator ani and obdurator muscles), urinalysis, uroflowmetry with residual urine measurement and transrectal ultrasonography of the prostate. Inclusion criteria included age more than 18 years, pelvic pain or discomfort for at least 3 months, NIH-CPSI greater than 15. Exclusion criteria were urinary tract infections in the past 6 months, a history of cancer, any neurological disorders, and transurethral procedures in a patient’s history. Each patient received individual treatment by a pelvic floor physical therapist, initially once a week and later on once every 2–4 weeks, depending on the progress made. The first session included paramedical anamnese, inspection of position, locomotion, mobi-
lity and breathing technique. Additionally, patients were familiarized with the anatomy and physiology of the pelvic organs and muscles using appropriate photographs and anatomical models. During the second treatment session the first exercise instructions were given and palpation of the pelvic floor muscles was performed. During the third session biofeedback measurements were performed and relaxation exercises started. A one-channel electromyography (EMG) biofeedback apparatus (Pelvined 932, EnrafNonius, the Netherlands) was used for EMG measurements. An EMG probe was placed in the anal canal in order to measure resting tone and strength of the levator ani muscle. Patients were taught in detail how to relax and constrict their pelvic floor muscles. The patient was placed in supine position with bended legs and asked to ‘‘hold back bowel movements or passing gas’’. Verbal guidance and feedback through palpation of the pelvic floor muscles and biofeedback measurements were used to teach how to correctly contract and relax the pelvic floor muscles. During the following sessions the exercises were designed to further relax and coordinate the pelvic floor muscles. Initially the exercises were performed while in supine position but later when sitting, standing and during daily activities. The NIH-CPSI total score, being a reliable and responsive measure of prostatitis symptoms, was used for the diagnosis and to monitor the effect of therapy. Moreover, pelvic floor muscle tonus measurements were used to complete the diagnosis and to monitor the effect of the biofeedback physical therapy. The therapy was evaluated after 6 to 8 treatment sessions. For statistical analysis the Wilcoxon signed ranks test for paired samples was performed. Where appropriate, Spearman’s correlation coefficient for nonparametric samples was calculated. A probability of less than 5% was defined as significant.
3. Results Two of the 33 men who were diagnosed with CP/ CPPS dropped out. One patient could not be properly trained because he did not understand the instructions. His pelvic floor muscle tonus was elevated and the NIH-CPSI was 21. The other patient stopped training after 3 sessions and did not return for follow up. The remaining 31 men were entered for analysis. The total CPSI score decreased after treatment for all patients except one (97%) (Fig. 1a). In the subdomain of micturition improvement was seen in 25 patients (81%), whereas for the subdomain pain the improvement was seen in 27 patients (87%) (Fig. 1b and c). In the subdomain of quality of life the score improved in 23 patients (74%). Thirteen patients (29%) even improved 5 points or more (Fig. 1d). All men exhibited abnormal anal sfincter tone on physical examination and in the majority of cases the levator ani muscle was most vulnerable. The EMG was performed in all. However, only in 18 patients pre- and post-treatment values were recorded. The post-treatment values decreased in all but one patient, in which it did not change (Fig. 1e). The mean value of the pelvic muscle tonus was 4.9 mV at diag-
E.B. Cornel et al. / European Urology 47 (2005) 607–611
609
Fig. 1. Comparison for all cases of the pre-treatment and post-treatment values. In (a) the CPSI and its subdomains in (b, c and d) In (e) the EMG-values.
610
E.B. Cornel et al. / European Urology 47 (2005) 607–611
Table 1 Results pre- and post-treatment Pre-treatment
NIH-CPSI NIH-CPSI NIH-CPSI NIH-CPSI EMG *
total (0–43) pain (0–21) micturition (0–10) QoL (0–12)
p-value*
Post-treatment
Mean
Range
Mean
Range
23.6 11.0 5.1 7.3 4.8
11–34 2–16 0–10 2–11 2.0–10.0
11.4 5.7 2.2 3.5 1.7
1–25 1–13 0–6 0–10 0.5–2.8
<0.001 <0.001 <0.001 <0.001 <0.001
Change range
2–26 1–10 0–9 2–9 0–7
Wilcoxon signed ranks test for paired samples.
nosis and decreased significantly to 1.7 mV after treatment. Summaries for the whole group are shown in Table 1. Within the total NIH-CPSI score, as well as in its specific subdomains, the decrease is highly significant (Table 1). The decrease has a good correlation with he initial score; i.e. the higher the initial score, the stronger the decrease (total CPSI r = 0.64; pain r = 0.45; micturition r = 0.74; quality of life r = 0.75; p < 0.001 for all). The one patient with an increase in CPSI, also had a one point increase in his pain and in his quality of life score, while his micturition score remained unchanged. On the other side of the spectrum, the patient with the strongest decrease in CPSI of 26 points, also had the highest decrease in his pain score of 10 points, the highest decrease in micturition score of 9 points, and a high decrease in quality of life score of 7 points. In general, there are good correlations between the changes in the total score and the subdomains pain (r = 0.8) and quality of life (r = 0.92), but moderate correlations with the micturition domain (r = 0.44). The correlations between the changes in the domains of pain and of micturition are good (r = 0.72). However, the change in the micturition domain is not correlated to that in the pain or the quality of life domain.
4. Discussion The specific mechanisms underlying the CP/CPPS syndrome have not been defined. Since the last decade some progress has been achieved in the understanding of this benign entity which has a severe impact on the quality of life of a CPPS patient [5,7–9,13]. For the evaluation of new therapies for CP/CPPS the NIHCPSI is considered a reliable and responsive measure of CP/CPPS in primary and secondary care [4]. Until recently, the prostate and bacterial infections were believed to play an important role in the pathophysiology of CP/CPPS [6]. However, it is now well
established that bacteria do not play a significant role in the development of CP/CPPS [7]. Thus far, only a few therapies have shown to be effective in the treatment of the debilitating symptoms of CP/CPPS [8,9,13] Alphablockade, tested in a double blinded randomised trial, showed a significant decrease in the NIH-CPSI score, particularly in the pain domain [8,9]. Uroselective alpha blockade works through the reduction of muscle tonus in the prostate gland, prostate capsule and the region of the bladder neck [14]. Surprisingly, the aforementioned study did not show significant effects on micturition. Segura et al. hypothesized that the muscle tone of the pelvic floor muscles i.e. levator ani and short external rotators may play a prominent role in the pathophysiology of CP [10]. Moreover, they suggest that the symptoms of patients, currently categorized as CP/CPPS, are similar to those having pelvic floor tension myalgia or levator ani syndrome. A recent case control study demonstrated that men with CP/CPPS indeed have significantly more abnormal pelvic floor muscular findings compared to a group of men without pain [12]. Specifically, it may be valuable to investigate the effects of biofeedback physical therapy and pelvic floor reeducation in CP/CPPS patients [13]. The present study clearly demonstrates a significant decrease in mean total NIH-CPSI score of 23.6 at baseline to 11.4 after treatment for all treatable patients. Regarding the specific domains of the NIH-CPSI, a significant decrease was seen in all subdomains. The decrease of the CPSI was highly correlated to decreases in the pain and quality of life domains, but only moderately to the decrease in the micturition domain. Moreover, we clearly demonstrate the benefit of this treatment with a concomitant decrease of the pelvic floor muscle tonus. This decrease further support the hypothesis that increased muscle tonus of the pelvic floor plays a pivotal role in the pathophysiology of CP/CPPS. However, the long-term durability of our outcomes has not yet been investigated. To our opinion the word prostate should be
E.B. Cornel et al. / European Urology 47 (2005) 607–611
omitted describing these symptoms, to avoid a ‘‘prostatocentric approach’’. In a study by Clemens in a group of 19 patients a meaningful improvement of symptoms was achieved in only 33% partially due to a high drop out rate [13]. Moreover, to accurately compare the efficacy of treatments for a given disease process, it is mandatory to have standard outcome measure. In the study performed by Clemens et al. the NIH-CPSI was not used which makes comparison with our results difficult [13]. Although we realize that comparison with a placebo group would have been more appropriate our results with this patient group is suggesting that we have been able to alter their natural disease. However, placebo treatment is impossible because patient participation and training are essential elements that cannot be mimicked by placebo treatment. Moreover, an improvement of up to 60% as a placebo effect, documented in uncontrolled trials assessing antibiotics,
611
pentosan polysulfate and other pharmacological agents, is still far less than the almost 100% improvement seen in our study.
5. Conclusions Our study clearly demonstrates the significant effect of biofeedback physical therapy and pelvic floor reeducation for CP/CPPS patients. The observation that the EMG results correlated with the NIH-CPSI score appears to emphasize that the pelvic floor plays an important role in the pathophysiology of CP/CPPS.
Acknowledgements We would like to thank Dr Egbert Oosterwijk for his critically comments of the manuscript.
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