National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) Symptom Evaluation in Multinational Cohorts of Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Background

The assessment of patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in everyday practice and clinical studies relies on National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) scores for symptom appraisal, inclusion criteria for clinical trials, follow-up, and response evaluation.

Objective

We investigated multiple databases of CP/CPPS patients to determine the prevalence and impact of pain locations and types to improve our strategy of individualized phenotypically guided treatment.

Design, setting, and participants

Four major databases with CPSI scores for nonselected CP/CPPS clinic patients from Canada, Germany, Italy, and the United States.

Outcome measurements and statistical analysis

Individual question scores and subtotal and total scores of CPSI were described and correlated with each other. Ordinal regression analysis was performed to define pain severity categories.

Results and limitations

A total of 1563 CP/CPPS patients were included. Perineal pain/discomfort was the most prevalent pain symptom (63%) followed by testicular pain (58%), pain in the pubic area (42%) and penis (32%); reports of pain during ejaculation and voiding were 45% and 43%, respectively. European patients had a significantly higher number of pain localizations and symptoms compared with North American patients (p < 0.001). Severity of pain correlated well with frequency of pain (r = 0.645). No specific pain localization/type was associated with more severe pain. Correlation of pain domain with quality of life (QoL) (r = 0.678) was higher than the urinary domain (r = 0.320). Individually, pain severity (r = 0.627) and pain frequency (r = 0.594) correlated better with QoL than pain localization (r = 0.354). Pain severity categories results for NIH-CPSI item 4 (0–10 numerical rating scale for average pain) were mild, 0–3; moderate, 4–6; severe, 7–10; CPSI pain domain (0–21): mild, 0–7; moderate, 8–13; and severe, 14–21.

Conclusions

Pain has more impact on QoL than urinary symptoms. Pain severity and frequency are more important than pain localization/type. Cut-off levels for disease severity categories have been identified that will prove valuable in symptom assessment and the development of therapeutic strategies.     

Extracorporeal Shock Wave Therapy for the Treatment of Chronic Pelvic Pain Syndrome in Males: A Randomised, Double-Blind, Placebo-Controlled Study

Background

There is no sufficiently validated therapy for chronic pelvic pain syndrome (CPPS).

Objective

To investigate the effects of extracorporeal shock wave therapy (ESWT) in 60 patients suffering from CPPS.

Design, setting, and participants

Sixty patients suffering from CPPS for at least 3 mo were investigated in two groups. Both groups were treated four times (once per week), each by 3000 impulses; group 2 was performed as a sham procedure. The investigation was designed as a placebo-controlled, prospectively randomised, double-blind phase 2 study. Standardised follow-up was performed 1, 4, and 12 wk after ESWT.

Interventions

Low-energy–density ESWT was performed using a perineal approach without anaesthesia. In the placebo group, the same setting was used without shock wave energy transmission.

Measurements

ESWT effects on pain, quality of life (QoL), erectile function (EF), and micturition were evaluated. The parameters were investigated using validated questionnaires (National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI], International Prostate Symptom Score [IPSS], International Index of Erectile Function [IIEF]) and the Visual Analog Scale (VAS) for pain evaluation.

Results and limitations

All patients completed outpatient treatments and follow-ups without any problems. All 30 patients in the verum group showed statistically (highly) significant improvement of pain, QoL, and voiding conditions following ESWT in comparison to the placebo group, which experienced a continuous deterioration of the same parameters during the follow-up period. Perineal ESWT was easy and safe to perform without anaesthesia or any side-effects.

Conclusions

This is the first prospectively randomised, double-blind study to reveal perineal ESWT as a therapy option for CPPS with statistically significant effects in comparison to placebo. ESWT may in particular be interesting because of its easy and inexpensive application, the lack of any side-effects, and the potential for repetition of the treatment at any time.     

Are Antisperm Antibodies Really Associated with Proven Chronic Inflammatory and Infectious Diseases of the Male Reproductive Tract?

Background

It is debated whether chronic urogenital inflammations and infections may trigger the formation of antisperm antibodies (ASA) in semen.

Objective

To evaluate the formation of ASA in defined chronic inflammatory and infectious diseases of the male reproductive tract (MRT).

Design, setting, and participants

Three hundred sixty-five patients retrospectively enrolled in a single center were categorized as having National Institutes of Health (NIH) category II chronic prostatitis (n = 38), NIH category IIIa chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) (n = 59), NIH category IIIb CP/CPPS (n = 213), chronic epididymitis (n = 34), and chronic urethritis (n = 21). Forty-five age-matched men served as controls.

Measurements

All subjects underwent microbiologic and cytologic analysis for common bacteria, yeasts, and mycoplasma using the four-glass test. Urine samples, ejaculates, and urethral swabs were analyzed with polymerase chain reaction (PCR) for Chlamydia trachomatis and Neisseria gonorrhea. Semen analysis followed World Health Organization (WHO) standards. ASA in seminal plasma were analyzed using the mixed agglutination reaction (MAR) test.

Results and limitations

The overall positive detection rate of clinically significant levels (≥50% of spermatozoa coated by ASA) of IgG and IgA antibodies was 1.8% and 0.8%, respectively, in the patient group. No clinically significant levels of ASA were detected in the control group, and no statistically significant difference was observed between controls and patients (IgG, p = 1.0; IgA, p = 1.0). No difference was found between the different inflammatory and infectious diseases and the control group in the detection rate of ASA, even when the cut-point value was lowered to ≥1% (IgG, p = 0.4; IgA, p = 0.3). Moreover, in one selected subgroup of patients (n = 26) with persistent increased inflammatory parameters (peroxidase-positive leukocytes [PPL] ≥1 × 10⁶/ml and elastase ≥230 ng/ml), no significant difference in the levels of ASA was observed compared with the controls (IgG, p = 0.1; IgA, p = 0.8).

Conclusion

There is no association between chronic inflammatory or infectious diseases of the MRT and the presence of ASA in semen.     

Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial

Background

Tadalafil improved lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH; LUTS/BPH) in clinical studies but has not been evaluated together with an active control in an international clinical study.

Objective

Assess tadalafil or tamsulosin versus placebo for LUTS/BPH.

Design, setting, and participants

A randomised, double-blind, international, placebo-controlled, parallel-group study assessed men ≥45 yr of age with LUTS/BPH, International Prostate Symptom Score (IPSS) ≥13, and maximum urinary flow rate (Q_max) ≥4 to ≤15 ml/s. Following screening and washout, if needed, subjects completed a 4-wk placebo run-in before randomisation to placebo (n = 172), tadalafil 5 mg (n = 171), or tamsulosin 0.4 mg (n = 168) once daily for 12 wk.

Measurements

Outcomes were assessed using analysis of covariance (ANCOVA) or ranked analysis of variance (ANOVA) (continuous variables) and Cochran-Mantel-Haenszel test or Fisher exact test (categorical variables).

Results and limitations

IPSS significantly improved versus placebo through 12 wk with tadalafil (−2.1; p = 0.001; primary efficacy outcome) and tamsulosin (−1.5; p = 0.023) and as early as 1 wk (tadalafil and tamsulosin both −1.5; p < 0.01). BPH Impact Index significantly improved versus placebo at first assessment (week 4) with tadalafil (−0.8; p < 0.001) and tamsulosin (−0.9; p < 0.001) and through 12 wk (tadalafil −0.8, p = 0.003; tamsulosin −0.6, p = 0.026). The IPSS Quality-of-Life Index and the Treatment Satisfaction Scale–BPH improved significantly versus placebo with tadalafil (both p < 0.05) but not with tamsulosin (both p > 0.1). The International Index of Erectile Function–Erectile Function domain improved versus placebo with tadalafil (4.0; p < 0.001) but not tamsulosin (−0.4; p = 0.699). Q_max increased significantly versus placebo with both tadalafil (2.4 ml/s; p = 0.009) and tamsulosin (2.2 ml/s; p = 0.014). Adverse event profiles were consistent with previous reports. This study was limited in not being powered to directly compare tadalafil versus tamsulosin.

Conclusions

Monotherapy with tadalafil or tamsulosin resulted in significant and numerically similar improvements versus placebo in LUTS/BPH and Q_max. However, only tadalafil improved erectile dysfunction.

Trial registration

Clinicaltrials.gov ID NCT00970632     

Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial

Background

Acupuncture therapy has been used by many researchers in both male and female sexual dysfunction studies.

Objective

To determine whether acupuncture is effective as a premature ejaculation (PE) treatment compared with paroxetine and placebo.

Design, setting, and participants

The study was conducted with methodologic rigor based on Consolidated Standards of Reporting Trials (CONSORT) criteria. Ninety patients referred to the urology clinic at a tertiary training and research hospital with PE were included in this randomized controlled trial and randomly assigned into paroxetine, acupuncture, and placebo groups. Heterosexual, sexually active men aged between 28 and 50 yr were included. Men with other sexual disorders, including erectile dysfunction; with chronic psychiatric or systemic diseases; with alcohol or substance abuse; or who used any medications were excluded.

Intervention

The medicated group received paroxetine 20 mg/d; the acupuncture or sham-acupuncture (placebo) groups were treated twice a week for 4 wk.

Measurements

Intravaginal ejaculation latency times (IELTs) and the Premature Ejaculation Diagnostic Tool (PEDT) were used to assess PE. IELTs were calculated by using a partner-held stopwatch. Data were analyzed statistically.

Results and limitations

Median PEDT scores of paroxetine, acupuncture, and placebo groups were 17.0, 16.0, and 15.5 before treatment, and 10.5, 11.0, and 16.0 after treatment, respectively (p = 0.001, p = 0.001, and p = 0.314, respectively). Subscores after treatment were significantly lower than subscores before treatment in the paroxetine and acupuncture groups but remained the same in the placebo group. Significant differences were found between mean-rank IELTs of the paroxetine and placebo groups (p = 0.001) and the acupuncture and placebo groups (p = 0.001) after treatment. Increases of IELTs with paroxetine, acupuncture, and placebo acupuncture were 82.7, 65.7, and 33.1 s, respectively. Extent of ejaculation delay induced by paroxetine was significantly higher than that of acupuncture (p = 0.001). The most important limitation of the study was the lack of follow-up.

Conclusions

Although less effective than daily paroxetine, acupuncture had a significant stronger ejaculation-delaying effect than placebo.     

Duloxetine for mild to moderate postprostatectomy incontinence: preliminary results of a randomised, placebo-controlled trial

Background

Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP).

Objective

To establish the superiority of duloxetine over placebo in SUI after RP.

Design, setting, and participants

We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80 mg of duloxetine daily or matching placebo for 3 mo.

Measurements

The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events.

Results and limitations

Thirty-one patients were randomised to either the treatment (n = 16) or control group (n = 15). Reduction in IEF was significant with duloxetine compared to placebo (mean ± standard deviation [SD] variation: −52.2% ± 38.6 [range: −100 to +46] vs +19.0% ± 43.5 [range: −53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0–101.4; p < 0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p = 0.006, p = 0.02, p = 0.0004, and p = 0.003, respectively). Both treatments were well tolerated throughout the study period.

Conclusions

Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.     

Prevention of recurrent urinary tract infections by intravesical administration of hyaluronic acid and chondroitin sulphate: a placebo-controlled randomised trial

Background

Urinary tract infection (UTI) is a prevalent condition in women during their lifetime with a high rate of recurrence within 3–6 mo.

Objectives

Our aim was to investigate the efficacy and tolerability of the intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS) in female patients with a history of recurrent UTI.

Design, setting, and participants

We conducted a prospective, randomised, double-blind, placebo-controlled study comparing the intravesical instillation of HA-CS with placebo in women with recurrent UTI.

Intervention

Participants were randomised to receive 50 ml of sterile sodium HA 1.6% and CS 2.0% solution (IALURIL^®) weekly for 4 wk and then monthly for 5 mo.

Measurements

The primary end point of the study was defined as the mean number of UTI per patient per year. Participants were evaluated addressing UTI status/urinary symptoms and with a general health-related quality-of-life (QoL) questionnaire at baseline and after 3, 6, 9, and 12 mo.

Results and limitations

In the intention-to-treat analysis, 57 women were randomly allocated to HA-CS (n = 28) or placebo (n = 29). The UTI rate per patient per year at the end of the study (12 mo) (mean ± SD: −86.6% ± 47.6 vs −9.6% ± 24.6; mean difference: 77%; 95% confidence interval, 72.3–80.8; p = 0.0002) and the mean time to UTI recurrence (52.7 ± 33.4 vs 185.2 ± 78.7 d; p < 0.001) were significantly reduced after treatment with HA-CS compared with placebo. Overall urinary symptoms and QoL measured by questionnaires significantly improved compared with placebo (Pelvic Pain and Urgency/Frequency questionnaire symptom score: 14.53 ± 4.32 vs 9.88 ± 6.77; p = 0.004; SF-36 QoL score: 78.6 ± 6.44 vs 53.1 ± 4.72; p < 0.001). No serious adverse event was reported.

Conclusions

Compared with placebo, HA-CS intravesical instillations significantly reduced UTI rate without severe side effects while improving symptoms and QoL over a 12-mo period in patients with recurrent UTI.

Trial registration

ISRCTN 76354426.     

Effects of Once-Daily Tadalafil on Erectile Function in Men with Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia

Background

Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH; BPH-LUTS) may be associated with erectile dysfunction (ED).

Objective

To evaluate the effects of once-daily tadalafil on erectile function in men with ED and BPH-LUTS.

Design, setting, and participants

Post hoc analysis of a phase 2–3, multinational, randomized, double-blind, placebo-controlled, parallel-group study of men with ED and moderate-to-severe LUTS secondary to BPH who reported being sexually active. In contrast to typical ED trials, no sexual activity threshold was required to participate.

Interventions

Screening and 4-wk washout period for patients taking BPH and/or ED treatments; 4-wk placebo run-in period; then once-daily placebo or tadalafil 2.5, 5, 10, or 20 mg for 12 wk.

Measurements

International Index of Erectile Function–Erectile Function (IIEF-EF) domain score, International Prostate Symptom Score (IPSS), peak urinary flow rate (Q_max), and postvoid residual volume (PVR). Analyses were performed in men who reported being sexually active with a female partner and who expected to remain so throughout the study. IIEF-EF data are presented for the BPH/ED population overall and for subgroups stratified by baseline age group, body mass index, BPH-LUTS severity, prostate-specific antigen, prior α-blocker use, and prior ED therapy.

Results and limitations

Overall, 581 men were included (placebo, n = 115; tadalafil 2.5 mg, n = 113; tadalafil 5 mg, n = 117; tadalafil 10 mg, n = 120; tadalafil 20 mg, n = 116). IIEF-EF domain score improvements from baseline to end point with tadalafil were 5.4 (2.5 mg), 6.8 (5 mg), 7.9 (10 mg), and 8.2 (20 mg) versus 2.0 with placebo (least-squares means; all p values <0.001). IIEF-EF domain score improvements were observed with tadalafil for all subgroup analyses, with no significant differences between subgroup or subgroup-by-treatment interaction terms. IPSS improvements from baseline to end point were significantly greater for all tadalafil doses versus placebo (all p values <0.05). Changes in Q_max and PVR were small and not clinically meaningful.

Conclusions

These data support the use of once-daily tadalafil in men with ED and BPH-LUTS.

Trial registration

http://www.clinicaltrials.gov: NCT00384930.     

Two modes of acupuncture as a treatment for hot flushes in men with prostate cancer--a prospective multicenter study with long-term follow-up

Background

Hot flushes are common and distressing among men with castrational treatment for prostate cancer. Of the few treatments, most have side effects.

Objective

Assess changes in hot flushes of electrostimulated (EA) and traditional acupuncture (TA).

Design, Setting, and Participants

Thirty-one men with hot flushes due to prostate cancer treatment were recruited from three urological departments in Sweden, from 2001 to 2004.

Intervention

Thirty-one men were randomized to EA (12 needle points, with 4 electrostimulated) or TA (12 needle points) weekly for 12 wk.

Measurements

Primary outcome: number of and distress from hot flushes in 24 h and change in “hot flush score.” Secondary outcome: change in 24-h urine excretion of CGRP (calcitonin gene–related peptide).

Results and Limitations

Twenty-nine men completed the treatment. Hot flushes per 24 h decreased significantly, from a median of 7.6 (interquartile range [IQR], 6.0–12.3) at baseline in the EA group to 4.1 (IQR, 2.0–6.5) (p = 0.012) after 12 wk, and from 5.7 (IQR, 5.1–9.5) in the TA group to 3.4 (IQR1.8–6.3) (p = 0.001). Distress by flushes decreased from 8.2 (IQR, 6.5–10.7) in the EA group to 3.3 (IQR, 0.3–8.1) (p = 0.003), and from 7.6 (IQR, 4.7–8.3) to 3.4 (IQR, 2.0–5.6) (p = 0.001) in the TA group after 12 wk, (78% and 73% reduction in “hot flush score,” respectively). The effect lasted up to 9 mo after treatment ended. CGRP did not change significantly. Few, minor side effects were reported.Limitations: small number of patients; no placebo control, instead a small group controlled for 6 wk pretreatment.

Conclusions

EA and TA lowered number of and distress from hot flushes. The hot flush score decreased 78% and 73%, respectively, in line with or better than medical regimens for these symptoms. Acupuncture should be considered an alternative treatment for these symptoms, but further evaluation is needed, preferably with a non- or placebo-treated control group.     

Nerve growth factor level in the prostatic fluid of patients with chronic prostatitis/chronic pelvic pain syndrome is correlated with symptom severity and response to treatment

Study Type – Therapy (case series) Level of Evidence 4

OBJECTIVE

• ? To explore whether levels of nerve growth factor (NGF) in expressed prostatic secretions (EPS) are correlated with symptom severity in chronic prostatitis (CP) and chronic pelvic pain syndrome (CPPS).

PATIENTS AND METHODS

• ? All patients with CP/CPPS underwent a complete history and physical examination, and were scored according to the National Institutes of Health Chronic Prostatitis Symptom Index (NIH‐CPSI).
• ? Expressed prostatic secretion samples from 20 patients with CP/CPPS and from four asymptomatic control patients were collected and frozen, and NGF levels in EPS were measured by enzyme‐linked immunosorbent assay.
• ? Patients were asked to complete NIH‐CPSI questionnaires at baseline and 8 weeks after treatment and patients with at least a 25% decrease in total NIH‐CPSI score from the baseline values were classified as responders to treatment.

RESULTS

• ? The mean (±sd ) NGF levels in EPS of patients with CP/CPPS and asymptomatic control patients were 7409 (±3788) pg/mL and 4174 (±1349) pg/mL, respectively. The NGF level in patients with CP/CPPS correlated directly with pain severity (P= 0.014, r= 0.541).
• ? There were no significant differences between NGF levels in EPS before and after treatment. However, successful treatment significantly decreased NGF levels in responders (P= 0.001).

CONCLUSION

• ? Nerve growth factor might contribute to the pathophysiology of CP/CPPS as changes in NGF level in EPS occurred in proportion to pain severity. Therefore, these results suggest that NGF could be used as a new biomarker to evaluate the symptoms of CP/CPPS and the effects of treatment.

     

Prospective randomised controlled trial comparing trigone-sparing versus trigone-including intradetrusor injection of abobotulinumtoxinA for refractory idiopathic detrusor overactivity

Background

Botulinum toxin A is effective for treatment of idiopathic detrusor overactivity (IDO). The trigone is generally spared because of the theoretical risk of vesicoureteric reflux (VUR), although studies assessing injection sites are lacking.

Objective

Evaluate efficacy and safety of trigone-including versus trigone-sparing intradetrusor injections of abobotulinumtoxinA in patients with IDO.

Design, setting, and participants

Twenty-two patients from one centre were randomised to trigone-including or trigone-sparing injections.

Intervention

Injection of 500 U abobotulinumtoxinA diluted to 20 ml into 20 trigone-including or trigone-sparing sites.

Measurements

The primary outcome measure was total overactive bladder symptom score (OABSS) at 6 wk. The OABSS questionnaire was completed at 0, 6, 12, and 26 wk. Baseline and postinjection urodynamic studies and micturating cystourethrograms were performed. Baseline values and subsequent time points were compared by t test. A mixed-effect model was used for repeated measures in time.

Results and limitations

For symptom scores at baseline compared with scores at 6 wk postinjection, the mean total OABSS improved from 22.4 to 8.7 (p < 0.001) in the trigone-including group compared with 22.7 to 13.4 (p < 0.03) in the trigone-sparing group. The difference in mean change from baseline was 4.4 points in favour of the trigone-including group (p = 0.03). The total OABSS at 12 and 26 wk and the urgency subscale scores at 6, 12, and 26 wk showed significant improvement in favour of the trigone-including group. Mean postvoid residual volumes and clean intermittent self-catheterisation rates between the two groups were similar. No patients developed VUR. Performing injections under general anaesthetic was a limitation, as tolerability under local anaesthetic was not assessed. A further limitation is the lack of a trigone-only arm.

Conclusions

Trigone-including injections are superior to trigone-sparing injections for the treatment of refractory IDO and did not cause VUR in this study.     

Both immediate and delayed intracavernous injection of autologous adipose-derived stromal vascular fraction enhances recovery of erectile function in a rat model of cavernous nerve injury

Background

Intracavernous injection of cultured adipose-derived stem cells (ADSCs) effectively restores erectile function in cavernous nerve (CN)–injured rats when administered at the time of injury. However, culturing exposes ADSCs to the risk of contamination and dedifferentiation.

Objective

Explore the effect of uncultured autologous adipose-derived stromal vascular fraction (SVF) on improving erectile function in a rat model of CN injury when administered at the time of injury or 4 wk after injury.

Design, setting, and participants

Eighty-nine male Sprague Dawley rats were randomly divided into four groups. CN injury or sham surgery was performed at the start of the study, and rats were treated with either SVF or vehicle. Functional testing and histologic analysis were performed 12 wk after CN crush or sham surgery.

Intervention

We used intracavernous injection of saline immediately after CN crush (n = 23), intracavernous injection of SVF immediately after CN crush (n = 17), intracavernous injection of SVF 4 wk after CN crush (n = 23), or sham surgery (n = 26).

Outcome measurements and statistical analysis

We studied intracavernous pressure (ICP) response to CN electrostimulation and performed histologic examination of midpenile cross-sections. Data were analyzed using one-way analysis of variance followed by the Tukey-Kramer test.

Results and limitations

Both immediate and delayed treatment with SVF resulted in a significantly increased ICP-to-mean arterial pressure ratio compared with the vehicle-treated group. Both immediate and delayed treatment with SVF significantly increased expression of neuronal nitric oxide synthase and neurofilament in dorsal penile nerves compared to the vehicle group. Furthermore, the smooth muscle-to-collagen ratio within the corpus cavernosum was significantly improved in both of the SVF groups compared to vehicle-treated rats. The main limitation of the study is the lack of determination of the SVF components.

Conclusions

Uncultured autologous SVF injected immediately or 4 wk after CN crush improved erectile function, promoted nerve regeneration, and prevented fibrosis of the corpus cavernosum following CN injury.     

Is There a Role for Tamsulosin in the Treatment of Distal Ureteral Stones of 7 mm or Less? Results of a Randomised,Double-Blind,Placebo-Controlled Trial

Background

Numerous randomised trials have confirmed the efficacy of medical expulsive therapy with tamsulosin in patients with distal ureteral stones; however, to date, no randomised, double-blind, placebo-controlled trials have been performed.

Objective

The objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.

Design, setting, and participants

Patients presenting with single distal ureteral stones ≤7 mm were included in this trial.

Intervention

Patients were randomised in a double-blind fashion to receive either tamsulosin or placebo for 21 d. The medication was discontinued after either stone expulsion or intervention. Abdominal computed tomography was performed to assess the initial and final stone status.

Measurements and limitations

The primary end point was the stone expulsion rate. Secondary end points were time to stone passage, the amount of analgesic required, the maximum daily pain score, safety of the therapy, and the intervention rate.

Results

Ten of 100 randomised patients were excluded from the analysis. No statistically significant differences in patient characteristics and stone size (median: 4.1 mm [tamsulosin arm] vs 3.8 mm [placebo arm], p = 0.3) were found between the two treatment arms. The stone expulsion rate was not significantly different between the tamsulosin arm (86.7%) and the placebo arm (88.9%; p = 1.0). Median time to stone passage was 7 d in the tamsulosin arm and 10 d in the placebo arm (log-rank test, p = 0.36). Patients in the tamsulosin arm required significantly fewer analgesics than patients in the placebo arm (median: 3 vs 7, p = 0.011). A caveat is that the exact time of stone passage was missing for 29 patients.

Conclusions

Tamsulosin treatment does not improve the stone expulsion rate in patients with distal ureteral stones ≤7 mm. Nevertheless, patients may benefit from a supportive analgesic effect.

Clinicaltrials.gov

NCT00831701.     

The impact of prostate size, median lobe, and prior benign prostatic hyperplasia intervention on robot-assisted laparoscopic prostatectomy: technique and outcomes

Background

Large prostate size, median lobes, and prior benign prostatic hyperplasia (BPH) surgery may pose technical challenges during robot-assisted laparoscopic prostatectomy (RALP).

Objective

To describe technical modifications to overcome BPH sequelae and associated outcomes.

Design, settings, and participants

A retrospective study of prospective data on 951 RALP procedures performed from September 2005 to November 2010 was conducted. Outcomes were analyzed by prostate weight, prior BPH surgical intervention (n = 59), and median lobes >1 cm (n = 42).

Surgical procedure

RALP.

Measurements

Estimated blood loss (EBL), blood transfusions, operative time, positive surgical margin (PSM), and urinary and sexual function were measured.

Results and limitations

In unadjusted analysis, men with larger prostates and median lobes experienced higher EBL (213.5 vs 176.5 ml; p < 0.001 and 236.4 vs 193.3 ml; p = 0.002), and larger prostates were associated with more transfusions (4 vs 1; p = 0.037). Operative times were longer for men with larger prostates (164.2 vs 149.1 min; p = 0.002), median lobes (185.8 vs 155.0 min; p = 0.004), and prior BPH surgical interventions (170.2 vs 155.4 min; p = 0.004). Men with prior BPH interventions experienced more prostate base PSM (5.1% vs 1.2%; p = 0.018) but similar overall PSM. In adjusted analyses, the presence of median lobes increased both EBL (p = 0.006) and operative times (p < 0.001), while prior BPH interventions also prolonged operative times (p = 0.014). However, prostate size did not affect EBL, PSM, or recovery of urinary or sexual function.

Conclusions

Although BPH characteristics prolonged RALP procedure times and increased EBL, prostate size did not affect PSM or urinary and sexual function.     

Chronic treatment with a type 5 phosphodiesterase inhibitor suppresses apoptosis of corporal smooth muscle by potentiating Akt signalling in a rat model of diabetic erectile dysfunction

Objectives

To examine whether chronic treatment with a type 5 phosphodiesterase inhibitor (PDE5I) could suppress corporal apoptosis via potentiation of Akt signalling in diabetic erectile dysfunction.

Methods

Sprague-Dawley rats (12 wk old) were divided into three groups (n = 12 in each): normal control, diabetes (DM), and diabetes treated with PDE5I (DM+PDE5I). The rats in the diabetic groups received a single injection of streptozotocin (50 mg/kg), and from 8 wk after establishment of diabetes, DM and DM+PDE5I were treated with vehicle and PDE5I (SK-3530, 10 mg/kg), respectively, for 4 wk. After 12 wk of streptozotocin injections, six rats in each group underwent cavernosometry with cavernous nerve electrostimulation (2 V, 0.2 ms, 50 s, 2.5–20 Hz). The penile tissues from the remaining six rats were used for immunohistochemical evaluation of apoptosis, immunoblotting for the phosphorylation of Akt and its downstream molecule Bad, and a colorimetric assay of caspase activity.

Results

Rats in the DM group showed markedly lower erectile parameters than those in the control group, whereas rats in the DM+PDE5I group showed normalized results. Despite persistent hyperglycaemia, PDE5I treatment significantly reduced the mean apoptotic index (39.6 ± 4.6 vs. 21.3 ± 1.7, p < 0.05). Densitometry revealed significantly higher levels of Akt and Bad phosphorylation, implying inhibition of pro-apoptotic stimuli. PDE5I treatment also significantly inhibited the activities of cavernosal caspase 3 and caspase 9, the main effectors of apoptosis.

Conclusions

Chronic treatment with PDE5I activated Akt signalling, which suppressed pro-apoptotic stimuli and maintained erectile function in rat model of diabetic erectile dysfunction.     

Botulinum toxin a versus placebo for refractory detrusor overactivity in women: a randomised blinded placebo-controlled trial of 240 women (the RELAX study)

Background

Emerging data suggest botulinum toxin is an effective treatment for detrusor overactivity (DO), but large studies confirming efficacy and safety are lacking.

Objective

Study the efficacy and safety of onabotulinumtoxinA (onaBoNTA) for the treatment of DO.

Design, setting, and participants

A double-blind placebo-controlled randomised trial in eight UK urogynaecology centres was conducted between 2006 and 2009. A total of 240 women with refractory DO were randomised to active or placebo treatment and followed up for 6 mo.

Intervention

Treatment consisted of 200 IU onaBoNTA or placebo injected into the bladder wall (20 sites; 10 IU per site in 1 ml saline).

Measurements

Primary outcome was voiding frequency per 24 h at 6 mo. Secondary outcomes included urgency and incontinence episodes and quality-of-life data. Intention-to-treat analysis was used with imputation of missing data.

Results and limitations

A total of 122 women received onaBoNTA and 118 received the placebo. Median (interquartile range) voiding frequency was lower after onaBoNTA compared with placebo (8.3 [6.83–10.0] vs 9.67 [8.37–11.67]; difference: 1.34; 95% confidence interval [CI], 1.00–2.33; p = 0.0001). Similar differences were seen in urgency episodes (3.83 [1.17–6.67] vs 6.33 [4.0–8.67]; difference: 2.50; 95% CI, 1.33–3.33; p < 0.0001) and leakage episodes (1.67 [0–5.33] vs 6.0 [1.33–8.33]; difference: 4.33; 95% CI, 3.33–5.67; p < 0.0001). Continence was more common after botulinum toxin type A (BoNTA; 31% vs 12%; odds ratio [OR]: 3.12; 95% CI, 1.49–6.52; p = 0.002). Urinary tract infection (UTI; 31% vs 11%; OR: 3.68; 95% CI, 1.72–8.25; p = 0.0003) and voiding difficulty requiring self-catheterisation (16% vs 4%; OR: 4.87; 95% CI, 1.52–20.33; p = 0.003) were more common after onaBoNTA.

Conclusions

This randomised controlled trial of BoNTA for refractory DO, the largest to date, confirms efficacy and safety of the compound. UTI (31%) and self-catheterisation (16%) are common. A third of women achieved continence.

Trial registration

The study received ethical committee approval from the Scottish Multicentre Research Ethics Committee (reference: 04/MRE10/67). The trial has a EudraCT number (2004-002981-39), a clinical trial authorisation from the UK Medicines and Healthcare Regulatory Agency, and it was registered on Current Controlled Trials (ISRCTN26091555) on May 26, 2005.     

Readaptation of the peritoneum following extended pelvic lymphadenectomy and cystectomy has a significant beneficial impact on early postoperative recovery and complications: results of a prospective randomized trial

Background

Prolonged postoperative pain and delayed intestinal transit are frequent problems following extended pelvic lymph-node dissection (PLND) and cystectomy.

Objective

To evaluate the impact of bilateral readaptation of the dorsolateral peritoneal layer on postoperative pain, gastrointestinal recovery, and complications following extended PLND and cystectomy.

Design, setting, and participants

Randomized, single-blinded, single-center study of 200 consecutive cystectomy patients.

Intervention

In group A (n = 100), lateral peritoneal flaps ventral to the external iliac vessels were bilaterally rotated over the iliac vessels down to the distal obturator fossa and medially fixed to the pararectal peritoneal layer following extended PLND and cystectomy. In group B (n = 100), the peritoneal layer was not readapted.

Measurements

Pain according to the visual analog scale (VAS), amount of peridural anesthetics needed, and gastrointestinal activity were assessed on postoperative days 1, 3, and 7. Complications occurring within 30 d following surgery were documented.

Results and limitations

Readaptation of the dorsolateral peritoneal layer resulted in a significant decrease in pain (p < 0.01) with concurrent significantly reduced need for peridural anesthetics (p < 0.01). Flatulence and first passage of stool as signs of intestinal transit were noted earlier in group A than in group B. Gastrostomy tube and peridural catheter could be removed 1 d earlier in group A than in group B (postoperative days 7 vs 8 and 6 vs 7, respectively). Group A (30%) had fewer complications than group B (56%; p < 0.001).

Conclusions

Readaptation of the dorsolateral peritoneal layer after extended PLND and cystectomy resulted in significantly less postoperative pain, earlier recovery of bowel function, and fewer complications in the early postoperative period.     

Dietary macronutrients, cholesterol, and sodium and lower urinary tract symptoms in men

Background

Little is known about dietary correlates of lower urinary tract symptoms (LUTS).

Objective

To examine associations between dietary intakes of total energy, carbohydrates, protein, fats, cholesterol, and sodium and LUTS in men.

Design, setting, and participants

Cross-sectional study of 1545 men aged 30–79 yr in the Boston Area Community Health survey (2002–2005), a random population-based sample. Dietary data were assessed by validated self-administered food frequency questionnaire. LUTS and covariate data were collected during in-person interviews. Primary analyses used multivariate logistic regression.

Measurements

Outcomes were moderate to severe LUTS, storage symptoms, and voiding symptoms as measured by the American Urological Association Symptom Index.

Results and limitations

Greater total energy intake was associated with higher LUTS symptom score (p_trend < 0.01) and increased likelihood of storage symptoms. No associations were observed with total, saturated, or monounsaturated fat intake or carbohydrates. Men who consumed more protein were less likely to report LUTS, particularly voiding symptoms (quintile 5 vs quintile 1 OR = 0.35; 95% CI, 0.17–0.74; p = 0.006). Sodium intake had positive linear associations with LUTS (p_trend = 0.01) and storage symptom score (p_trend = 0.004); this finding should be confirmed by studies using biomarkers of sodium exposure. Storage symptoms increased slightly with greater polyunsaturated fat intake (p_trend = 0.006). Data on specific polyunsaturated fats were unavailable.

Conclusions

This community-based study of men found that total energy and sodium intake were positively associated with LUTS, whereas greater protein intake was inversely associated with LUTS.     

Chronic kidney disease after nephrectomy in patients with small renal masses: a retrospective observational analysis

Context

Chronic kidney disease (CKD) is a worldwide health threat associated with increased cardiovascular disease and mortality.

Objective

To examine postoperative CKD in patients with small renal masses (SRMs) treated with partial nephrectomy (PN) or radical nephrectomy (RN).

Design, setting, and participants

A US National Cancer Institute Surveillance Epidemiology and End Results (SEER)–Medicare-linked retrospective cohort of 4633 T1aN0M0 renal cell carcinoma (RCC) patients who underwent PN or RN.

Outcome measurements and statistical analysis

The primary outcome of interest was the onset of CKD stage ≥3. Secondary end points comprised acute renal failure (ARF), chronic renal insufficiency (CRI), anemia in CKD, and end-stage renal disease (ESRD). Kaplan-Meier and Cox regression analyses were performed.

Results and limitations

Postpropensity matching resulted in 840 RN and PN patients. In multivariable analyses, RN patients were 1.9-, 1.4-, 1.8-, and 1.8-fold more likely to have an occurrence of CKD, ARF, CRI, and anemia in CKD, respectively (all p ≤ 0.004). The risk of ESRD between treatment groups failed to achieve statistical significance (p = 0.06).

Conclusions

PN is associated with more favorable postoperative renal function outcomes relative to RN in the setting of SRMs.     

EAU Guidelines on Chronic Pelvic Pain

Context

These guidelines were prepared on behalf of the European Association of Urology (EAU) to help urologists assess the evidence-based management of chronic pelvic pain (CPP) and to incorporate the recommendations into their clinical practice.

Objective

To revise guidelines for the diagnosis, therapy, and follow-up of CPP patients.

Evidence acquisition

Guidelines were compiled by a working group and based on a systematic review of current literature using the PubMed database, with important papers reviewed for the 2003 EAU guidelines as a background. A panel of experts weighted the references.

Evidence synthesis

The full text of the guidelines is available through the EAU Central Office and the EAU Web site (www.uroweb.org). This article is a short version of the full guidelines text and summarises the main conclusions from the guidelines on the management of CPP.

Conclusions

A guidelines text is presented including chapters on chronic prostate pain and bladder pain syndromes, urethral pain, scrotal pain, pelvic pain in gynaecologic practice, neurogenic dysfunctions, the role of the pelvic floor and pudendal nerve, psychological factors, general treatment of CPP, nerve blocks, and neuromodulation. These guidelines have been drawn up to provide support in the management of the large and difficult group of patients suffering from CPP.