Consolidation therapy is necessary following successful biofeedback treatment for pubertal chronic prostatitis patients: A 3-year follow-up study

Abstract

Objective

To assess long-term effects of biofeedback training on pubertal chronic prostatitis (CP).

Methods

Pubertal CP patients received 12-week intensive biofeedback training and were divided into two groups: group 1 received further monthly training ≥24 (26–36) months; group 2 received further monthly training <24 (13–23) months. National Institutes of Health–CP Symptom Index (NIH–CPSI) scores, maximum urinary flow rate (Q_max) and postvoid residual urine volume (PVR) were recorded monthly.

Results

Total NIH–CPSI scores decreased significantly in group 1 (n = 10; mean age ± SD 16.5 ± 1.1 years) together with all subdomain scores (pain, urination, life impact). Total NIH–CPSI scores increased significantly in group 2 (n = 12; mean age ± SD 16.3 ± 1.2 years) at 30 and 36 months, and were significantly different from group 1 at these time points. Urination and life-impact scores increased significantly and Q_max decreased significantly in group 2 at 30 and 36 months. PVR was unchanged in either group.

Conclusions

Twelve-week intensive biofeedback training requires lengthy consolidation sessions to achieve long-term success. Further investigation should assess longer intervals between consolidation sessions, for improving patient compliance and outcome.

Keywords

Biofeedback chronic prostatitis National Institutes of Health–Chronic Prostatitis Symptom Index (NIH–CPSI)puberty follow-up urodynamics

Introduction

The pathogenesis of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is unclear, making treatment difficult.¹ The cause of CP may be associated with pelvic-floor abnormalities,² with the majority of CP patients in one study having pathological tenderness of the striated pelvic-floor muscles and poor or absent pelvic-floor function.³ Pelvic-floor biofeedback training has been applied to the treatment of CP, whereby specific instruments are used to teach patients how to contract and relax pelvic muscles selectively, while keeping other muscles relaxed.^4,5

There are few reports regarding the treatment of pubertal patients with CP. The authors of the present study published data on 25 male adolescents with CP who underwent biofeedback training and obtained satisfactory short-term results.⁶ The initial study showed that the main type of CP during puberty is the National Institutes of Health (NIH) prostatitis classification category IIIB (chronic prostatitis/chronic pelvic pain syndrome, noninflammatory),⁷ with voiding disorder as the dominating symptom. The impact on health-related quality of life and psychological effects are substantial. Using the NIH–CP Symptom Index (NIH–CPSI) scores,⁸ our earlier study reported mean pain subscores of 4.0 among pubertal CP patients prior to receiving biofeedback treatment.⁶ Pain subscores among adults with CP are reported to be ∼11.0.^9,10 It has been suggested that disease characteristics are different among patients with CP during puberty. Pubertal males with CP have pelvic-floor dysfunction and several abnormal urodynamic features including staccato voiding, detrusor–sphincter dys-synergia, decreased maximum urinary flow rate (Q_max), and increased detrusor pressure at maximum cystometric capacity and maximum urethral closure pressure.⁶ The short-term (12-week) effect of biofeedback strategies for treating pubertal CP is satisfactory because of the significant difference in NIH–CPSI scores and Q_max before and after treatment.⁶ The long-term durability of biofeedback therapy for pubertal CP patients remains unknown, however. Whether it is necessary to add follow-up consolidation therapy for these patients remains to be understood.

The present follow-up investigation explored the long-term effects and optimal treatment protocol for pubertal CP patients.

Patients and methods

Study Population

This follow-up study was conducted at the Department of Urology, Xiang Ya Hospital, Central South University, Changsha City, Hunan Province, China, between March 2006 and March 2009. Consecutive pubertal CP patients who had received 12-week intensive biofeedback training (as described in Li et al.⁶) were enrolled. There were no other specific inclusion or exclusion criteria for the study. Ultrasound examinations were performed to exclude any possible urological anatomical abnormalities. Following prostate massage, expressed prostatic secretions and urine samples were cultured to determine the presence of bacterial infection. Patients were categorized according to the NIH–CPSI score criteria.⁷

Patients or their parents provided written informed consent and the study was approved by the Institutional Review Board of Central South University.

Study Design and Assessments

Patients received follow-up consolidation biofeedback training once per month for 13–36 months. Biofeedback training was administered via a system that allowed simultaneous recording of urine flow, abdominal pressure and anal electromyogram (EMG) (Urostym; Laborie, Montreal, Canada). An anal electrode was used to indicate changes in EMG and a balloon catheter was placed in the rectum to measure abdominal pressure. Patients were taught to perceive relaxation and contraction of the anal sphincter, and instructed to contract while simultaneously maintaining stable abdominal pressure. Once the patient understood this procedure they chose the optimal position for relaxation of the pelvic-floor muscles. They were then instructed to urinate when sitting with the thighs spread (to relax the perineum), while leaning forward slightly with a straight back. Each session lasted 20–30 min. During these visits, NIH–CPSI scores,⁸ maximum urinary flow rate (Q_max, obtained using free uroflowmetry)¹¹ and postvoid residual volume (PVR, obtained using ultrasound) were measured and recorded for each patient.

Patients were divided into two groups depending on the duration of consolidation sessions; the duration of consolidation sessions was based on each patient’s own decision to comply. Group 1 received biofeedback training once a month for ≥24 months after the initial 12-week intensive training, and group 2 received <24 months’ training. Patients in group 2 were still required to attend the clinic for assessment and data collection on a monthly basis for up to 36 months, even after their follow-up training was suspended. No antibiotic or α-blocker treatments were used on any of the patients in this study.

Statistical Analyses

Statistical analyses were carried out using the SPSS® software package, version 11.0 (SPSS Inc., Chicago, IL, USA) for Windows®. Data were reported as mean ± SD values or median values (interquartile range). Between-group comparisons of NIH–CPSI scores, Q_max and PVR were performed using the Mann–Whitney U-test or independent-samples t-test. Kendall's W-test was used to analyse within-group changes in total and subdomain NIH–CPSI scores. One-way analysis of variance was used for within-group comparisons of Q_max and PVR. A P-value <0.05 was considered to be statistically significant.

Results

A total of 22 patients were included in the study: 10 patients (mean ± SD 16.5 ± 1.1 years of age) were assigned to group 1 and received monthly follow-up training for a mean of 29 months (range 26–36 months) following initial 12-week intensive biofeedback training; 12 patients (mean ± SD 16.3 ± 1.2 years of age) were assigned to group 2 and received follow-up training for a mean of 18 months (range 13–23 months) following initial 12-week intensive biofeedback training. Of the 22 patients, one was categorized as NIH prostatitis classification category IIIA (chronic prostatitis/chronic pelvic pain syndrome, inflammatory) and 21 patients were categorized as NIH prostatitis classification category IIIB (chronic prostatitis/chronic pelvic pain syndrome, noninflammatory).

All 20 patients found to have staccato voiding in the previous study⁶ were included in the present analysis. Of the 20 patients with staccato voiding, after initial 12-week intensive biofeedback training, symptoms completely disappeared in 17 patients and partial improvement was observed in three patients (two of whom were assigned to group 1; one was assigned to group 2). Staccato voiding of the two patients in group 1 completely disappeared following 12 weeks’ consolidation therapy, with no cases reappearing in this group. Staccato voiding of the one case in group 2 also disappeared after 12 weeks’ consolidation therapy, but this voiding pattern reappeared 6 months after biofeedback sessions were suspended. In addition, a further two cases of staccato voiding appeared in group 2 at 36 months, i.e. in the period after follow-up biofeedback training had been suspended.

Follow-up training sessions in group 2 were suspended due to poor therapeutic compliance. Some patients in group 1 also did not receive follow-up training for the full 36 months, due to poor therapeutic compliance.

Total NIH–CPSI scores in group 1 decreased gradually and significantly (P < 0.001) throughout the follow-up training period (Table 1). Total NIH–CPSI scores in group 2 increased significantly at 30 and 36 months (compared with baseline, P < 0.001) and were significantly different from group 1 at 30 and 36 months (P ≤ 0.01). There was no significant change in Q_max over time for group 1, whereas Q_max decreased in group 2 at 30 and 36 months compared with baseline, i.e. in the period after biofeedback training had been suspended (P < 0.001). PVR did not change significantly over time in either group (Table 1).

Table 1.

National Institutes of Health–Chronic Prostatitis Symptom Index (NIH–CPSI) total scores, maximum urinary flow rate (Q_max) and postvoid residual volume (PVR) data for pubertal chronic prostatitis patients who received consolidation follow-up biofeedback training for ≥24 months (Group 1; mean age ± SD 16.5 ± 1.1 years) or <24 months (Group 2; mean age ± SD 16.3 ± 1.2 years), on completion of 12 weeks’ intensive biofeedback trainin.

Parameter	Group 1 n = 10	Group 2 n = 12	Statistical significance^a
NIH–CPSI score, months
0	7.5 (3.7)	9.0 (6.7)	NS
6	7.5 (4.7)	8.5 (4.2)	NS
12	6.5 (3.2)	6.0 (2.5)	NS
18	5.5 (3.0)	5.0 (3.2)	NS
24	6.0 (3.2)	5.5 (4.7)	NS
30	3.0 (2.5)	13.5 (9.5)	P = 0.001
36	2.0 (1.2)	15.0 (2)	P < 0.001
Statistical significance^b	P < 0.001	P < 0.001^c
Q_max, ml/s, months
0	13.7 ± 1.9	14.5 ± 1.3	NS
6	12.6 ± 1.5	11.8 ± 1.6	NS
12	13.1 ± 1.1	12.7 ± 1.9	NS
18	13.7 ± 1.2	13.0 ± 1.4	NS
24	13.9 ± 1.1	12.7 ± 1.5	NS
30	13.8 ± 1.0	11.6 ± 1.6	P = 0.002
36	14.0 ± 1.2	9.5 ± 2.2	P < 0.001
Statistical significance^c	NS	P < 0.001^c
PVR, ml, months
0	5.9 ± 2.6	5.6 ± 2.8	NS
6	4.6 ± 2.8	4.7 ± 3.7	NS
12	4.3 ± 2.2	4.3 ± 2.2	NS
18	4.6 ± 1.2	4.7 ± 1.5	NS
24	5.2 ± 1.1	5.4 ± 1.3	NS
30	5.3 ± 1.2	5.4 ± 1.7	NS
36	5.2 ± 1.3	5.2 ± 1.3	NS
Statistical significance^d	NS	NS

Data presented as median (interquartile range) or mean ± SD.

Between-group analysis, Mann–Whitney U-test or independent samples t-test.

Within-group analysis, Kendall's W-test.

Statistically significantly different versus baseline only at months 30 and 36 in Group 2.

Within-group analysis, one-way analysis of variance.

0 months, represents commencement of follow-up training on completion of intensive 12-week biofeedback training.

NS, no statistically significant between-group or within-group differences (P ≥ 0.05).

Group 1 NIH–CPSI subdomain scores (including pain, urination and life impact) showed a significant gradual decrease (P < 0.001) (Table 2). Group 2 urination and life-impact scores significantly increased at 30 and 36 months (compared with baseline; P < 0.001), although pain scores did not change significantly (Table 2). NIH–CPSI subdomain scores for pain, urination and life impact were all significantly different in groups 1 vs group 2 at 30 and 36 months (P ≤ 0.01, all comparisons; Table 2).

Table 2.

National Institutes of Health–Chronic Prostatitis Symptom Index (NIH–CPSI) subdomain scores for pubertal chronic prostatitis patients who received consolidation follow-up biofeedback training for ≥ 24 months (Group 1; mean age ± SD 16.5 ± 1.1 years) or <24 months (Group 2; mean age ± SD 16.3 ± 1.2 years), on completion of 12 weeks’ intensive biofeedback trainin.

NIH–CPSI subdomain	Group 1 n = 10	Group 2 n = 12	Statistical significance^a
Pain, months
0	2.0 (2.0)	3.0 (2.0)	NS
6	2.0 (1.2)	2.0 (1.0)	NS
12	2.0 (1.0)	1.5 (1.0)	NS
18	1.5 (2.0)	1.0 (1.0)	NS
24	1.5 (1.0)	1.0 (2.0)	NS
30	1.0 (0.5)	2.0 (2.2)	P = 0.01
36	0.2 (1.0)	2.0 (2.0)	P < 0.001
Statistical significance^b	P < 0.001	NS
Urination, months
0	3.0 (1.2)	3.0 (3.2)	NS
6	3.5 (2.0)	3.0 (1.5)	NS
12	3.0 (2.0)	2.5 (1.0)	NS
18	2.0 (1.0)	3.0 (1.2)	NS
24	2.0 (1.5)	2.0 (2.2)	NS
30	1.0 (1.0)	5.0 (3.2)	P < 0.001
36	1.0 (0.2)	7.0 (2.0)	P < 0.001
Statistical significance^b	P < 0.001	P < 0.001^c
Life impact, months
0	2.0 (2.2)	3.1 (3.0)	NS
6	2.0 (2.1)	3.0 (2.0)	NS
12	2.0 (0.5)	2.0 (1.0)	NS
18	2.0 (1.0)	1.5 (1.0)	NS
24	2.0 (1.1)	1.5 (2.5)	NS
30	1.1 (1.0)	5.0 (4.2)	P = 0.01
36	1.0 (0.0)	6.0 (3.5)	P < 0.001
Statistical significance^b	P < 0.001	P < 0.001

Data presented as median (interquartile range).

Between-group analysis, Mann–Whitney U-test.

Within-group analysis, Kendall's W-test.

Statistically significantly different versus baseline only at months 30 and 36 in Group 2.

0 months, represents commencement of follow-up training on completion of intensive 12-week biofeedback training.

NS, no statistically significant between- or within-group differences (P ≥ 0.05).

Discussion

The term ‘biofeedback’ describes procedures developed in the 1940s for training subjects to alter physiological responses such as brain activity, blood pressure, muscle tension, or heart rate.¹² Urodynamic biofeedback was first reported for managing voiding dysfunction in children.¹³ Biofeedback training teaches participants to improve their health and performance using their own body signals, strengthening awareness of the connections between mind and body.^14–16 Biofeedback training has been shown to improve symptoms of CP in pubertal patients, over the short term.⁶ The long-term effects of various treatment options for pubertal CP patients, including biofeedback training, remain unclear, however.

The present study showed that 12-week intensive biofeedback training, followed by successive consolidation treatment for pubertal CP, was effective in most patients. NIH–CPSI scores for those who received follow-up biofeedback training for ≥ 24 months gradually and significantly decreased, with no significant changes in Q_max and PVR, indicating that consolidation biofeedback treatment for pubertal patients with CP was satisfactory. In patients who received follow-up biofeedback training for < 24 months, NIH–CPSI scores decreased up to 24 months but then began to increase, mainly due to increasing urination and life-impact subdomain scores. Q_max in these patients decreased significantly after treatment was suspended. Symptoms of pubertal CP patients in the present study deteriorated rapidly after biofeedback training was suspended for >6 months, even if follow-up consolidation biofeedback treatment had been conducted for >18 months.

The exact mechanisms through which biofeedback training improves the symptoms of patients with CP are complex.⁹ It is unclear why 12 weeks’ intensive biofeedback training, followed by successive consolidation therapy for >18 months, did not resolve CP symptoms in the present study. There are various theories regarding the basic causes of CP. A six-domain clinical phenotype-based classification system (urinary, psychosocial, organ-specific, infection, neurologic/systemic and tenderness) has been proposed as a means of improving the understanding and management of chronic prostatitis/chronic pelvic pain syndrome and interstitial cystitis/bladder pain syndrome.^17,18 The suggestion was that successful management of CP will result from interventions that are specific to a patient’s needs.^17,18 The psychological effects and impact on health-related quality of life were substantial in the present study and in the previously published report on CP during puberty.⁶ Patients may benefit more from biofeedback training if they could recognize the basic aetiology of CP and understand the benefit of relaxation. Treating one specific symptom (such as urinary dysfunction or tenderness) may not be sufficient. Consequently, a combination of biofeedback training with other therapies such as psychological treatment may offer greater efficacy.

The dominating symptom of pubertal CP patients is voiding disorder.⁶ Dysfunctional voiding (including staccato and fractionated voiding) has been considered to be an abnormal contraction of the voluntary sphincter mechanism, which can be managed by biofeedback therapy.^19–21 It was assumed that children with dysfunctional voiding in these two studies were different from the pubertal CP patients included in the present study who showed voiding disorder, where intensive biofeedback training was not sufficient.

Patients who received follow-up biofeedback for <24 months showed gradually decreasing Q_max scores and increasing pain and life-impact scores, following suspension of biofeedback training. One study reviewed the charts of 77 children with dysfunctional voiding, where follow-up biofeedback therapy sessions were scheduled at 4- to 8-week intervals.²² Success, improvement and failure were achieved in 22 (28.6%), 29 (37.7%) and 26 cases (33.7%) respectively. The study reported that children who completed three biofeedback sessions were more likely to succeed in improving their staccato voiding pattern. Compared with the present study, far fewer sessions were used to treat children with dysfunctional voiding, however, the patients (mean age, 9 years) were younger than those included in the present study. Since biofeedback training once per month was not tolerated by some patients in the present study, a further investigation should consider follow-up biofeedback training at 2- or 3-month intervals, but not at intervals >6 months.

The present study was limited by the fact that incidence of CP in puberty is relatively low and there were not enough patients recruited to create a control group with no intervention. In addition, the follow-up data were difficult to collect. The sample sizes for each group were relatively low, although adequate to meet the demands of statistical design.

In conclusion, a successful outcome was achieved in pubertal patients with CP following an initial 12-week period of intensive biofeedback training. Nevertheless, a subsequent relatively long duration of consolidation sessions is needed to maintain these results. A modified follow-up training schedule should be further investigated, to assess whether longer intervals between follow-up biofeedback training would be as effective as monthly intervals and better tolerated by patients, thereby improving patient compliance and outcomes.

Footnotes

Declaration of Conflicting Interest

The Authors declare that there are no conflicts of interest.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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