Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

Treatment of neurogenic male urinary incontinence related to intrinsic sphincter insufficiency with an artificial urinary sphincter: a French retrospective multicentre study.

OBJECTIVE: To assess results and morbidity of the periprostatic insertion of an artificial urinary sphincter (AUS) in adult male patients with a neurogenic bladder. PATIENTS AND METHODS: A retrospective study was carried out on 51 adult male patients operated on in four urologic academic wards from April 1988 to January 2008. Among these patients, 31% (16/51) had spina bifida and 69% (35/51) had spinal cord injury. All patients suffered urinary incontinence secondary to sphincteric deficiency, and this was associated with detrusor overactivity in 39% of them (leading in these cases to an added bladder augmentation). Perfect continence was defined as a period of dryness of at least 4 h between two self-intermittent catheterizations (SIC) or spontaneous micturitions, moderate incontinence as nocturnal leakage or need to wear protection once during the day or for stress leakage, while severe incontinence was defined as uncontrollable leakage causing patient discomfort. RESULTS: Mean age at the procedure was 35 years (18-58). Mean follow-up was 83 months (CI 95%, 65-101). At the end of the study, 15 patients (29.4%) were lost to follow-up. One patient (2%) died shortly after the procedure from a pulmonary infection. Post-operative morbidity was observed in 19% (10/50) of the patients (8 urinary tract infection, 1 failure to perform SIC, 1intracranial hypertension). Of the patients in our study 74% had perfect or moderate continence with a working AUS after a 10-year follow-up CONCLUSIONS: We present a specific study on adult patients with a neurological lesion leading to bladder dysfunction treated by a periprostatic AUS. This procedure was effective in restoring urinary incontinence in the vast majority of our patients with an acceptable morbidity.

Combination of doxazosin and sildenafil exerts an additive relaxing effect compared with each compound alone on human cavernosal and prostatic tissue.

INTRODUCTION: Phosphodiesterase 5 inhibitors (PDE5) such as sildenafil are first-line treatment for erectile dysfunction (ED). Alpha1 (alpha1)-adrenoceptor antagonists such as doxazosin are indicated for the treatment of patients with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH). ED and LUTS/BPH are conditions that are often associated. Accordingly, alpha1-adrenoceptor antagonists and PDE5 inhibitors will be often prescribed in real life setting together. AIM: To evaluate the effects of the combination of sildenafil and doxazosin on human cavernosal and prostatic tissue. METHODS: Prostatic and erectile tissues were obtained from nine to 12 patients, respectively. Patients underwent cystoprostatectomy for infiltrating bladder cancer or penile surgery for penile implant, congenital curvature or Peyronie's disease. MAIN OUTCOME MEASURES: In organ baths, prostatic and cavernosal strips were submitted to either concentration-response curves (CRC) to phenylephrine (Phe) or norepinephrine (NE), respectively, in presence of vehicle, sildenafil (10(-6) M, 10(-5) M), doxazosin (10(-8) M, 3.10(-8) M, or 10(-7) M), or a combination of both. Continuous electrical field stimulation (EFS; 32 Hz, 5 ms, 5 seconds, 300 mA) was performed on prostatic strips which were incubated with sildenafil 10(-6) M or vehicle before the successive addition of doxazosin (10(-7) M, 10(-6) M) or vehicle. Cavernosal strips were pre-incubated with doxazosin (10(-9) M, 10(-8) M) or vehicle, then CRC to sildenafil were constructed on NE (3.10(-6) M) precontracted cavernosal strips. RESULTS: Combination of sildenafil and doxazosin exerted a greater relaxing effect on CRC to Phe or NE compared with each compound alone in both tissues. Sildenafil significantly enhanced the relaxing effect of doxazosin on EFS-induced contractions in prostatic strips. Doxazosin significantly increased the ability of sildenafil to inhibit NE-induced contractions in cavernosal strips. CONCLUSIONS: Sildenafil and doxazosin reduced adrenergic tone of prostatic and cavernosal smooth muscle and their combination provided a significant benefit when targeting relaxation of both tissues. These experiments provide support for further clinical evaluation of the sildenafil and doxazosin combination in ED patients with LUTS/BPH.

Use of forearm free-flap phalloplasty in bladder exstrophy adults.

OBJECTIVE: To assess the long-term outcome and cosmetic results of forearm free-flap phalloplasty for correcting micropenis associated with bladder exstrophy in men. PATIENTS AND METHODS: From 1992 to 2000, six men with bladder exstrophy and unsatisfactory penile appearance underwent phalloplasty at our institution. The mean (range) follow-up was 113 (62-153) months. The surgical procedure consisted of a modified radial free-flap phalloplasty and prosthesis implantation. One-stage urethroplasty was electively performed according to the patient's voiding pattern. Early and late complications were recorded and quality of life after phalloplasty was assessed. RESULTS: The mean (range) age was 21.2 (17-26) years and flap survival was 100%. Two incontinent patients underwent immediate perineal urethrostomy. One sepsis occurred, requiring the removal of the penile prosthesis and a cutaneous continent urinary diversion; this patient was the only one to complain about the outcome. Two anastomotic urethral strictures were conservatively treated by endoscopic urethrotomy and only one patient underwent subsequent urethral self-dilatations. Five patients were very satisfied with the cosmesis of the neophallus and three patients reported having regular sexual intercourse. CONCLUSIONS: Although short, this series indicates the low incidence of early complications and the excellent long-term satisfaction with forearm free-flap phalloplasty in bladder exstrophy. Phalloplasty has potential indications when adult exstrophy patients are dissatisfied with the cosmetic appearance of their external genitalia or have unsatisfactory sexual intercourse.

Perceived physiological and orgasmic sensations at ejaculation in spinal cord injured men.

INTRODUCTION: With the advances in penile vibrator stimulation (PVS), most spinal cord injured (SCI) men can self-ejaculate. Oral midodrine may further increase ejaculation success, while maintaining autonomy. Since most SCI men attempt ejaculation for sexual rather than reproductive purposes, self-ejaculation should be emphasized and sensations explored. AIMS: Explore (i) self-ejaculation success rate in SCI men; (ii) vascular parameters indicative of autonomic dysreflexia (AD) during sexual stimulation and ejaculation; and (iii) sensations associated with ejaculation. METHODS: Ejaculation was assessed on 81 SCI men with complete ASIA A (49%) and incomplete B to D lesions (51%), subdivided into tetraplegics (C2-T2), paraplegics sensitive to AD (T3-T6), paraplegics not sensitive to AD (T7-T10), paraplegics with lesions to the emission pathway (T11-L2), and paraplegics with lesions interrupting the emission-ejaculation pathways (L3-below). Natural stimulation was attempted first followed, if negative, by PVS followed, if again negative, by PVS combined with oral midodrine (5-25 mg). MAIN OUTCOME MEASURES: Ejaculation success, systolic and diastolic blood pressure, and perceived physiological and orgasmic sensations. RESULTS: Overall 91% reached ejaculation, 30% with natural stimulation, 49% with PVS and 12% with midodrine plus PVS. Midodrine salvaged up to 27% depending upon the lesion. Physiological and orgasmic sensations were perceived significantly more at ejaculation than sexual stimulation. Tetraplegics did not differ from paraplegics sensitive to AD on perceived cardiovascular and muscular sensations, but perceived significantly more autonomic sensations, and generally more physiological sensations than lower lesions unsensitive to AD. CONCLUSION: Most SCI men can self-ejaculate and perceive physiological and orgasmic sensations. The climactic experience of ejaculation seems related to AD, few sensations being reported when AD is not reached, pleasurable climactic sensations being reported when mild to moderate AD is reached, and unpleasant or painful sensations reported with severe AD. Sexual rehabilitation should emphasize self-ejaculation and self-exploration and consider cognitive reframing to maximize sexual perceptions.

Long-term outcome of forearm flee-flap phalloplasty in the treatment of transsexualism.

OBJECTIVE: To assess the long-term outcome of forearm free-flap phalloplasty in transsexuals, as obtaining a satisfying neophallus in female-to-male transsexuals is a surgical challenge. PATIENTS AND METHODS: We analysed retrospectively 56 transsexuals who had a phalloplasty using a radial forearm free-flap in our department from 1986 to 2002. The complication rate was assessed by regular examination. Patient satisfaction was evaluated by a questionnaire about cosmetic aspects, sexual life and overall satisfaction. RESULTS: The mean follow up was 110 months; 53 of the 56 patients (95%) currently have a neophallus, after a mean of six surgical procedures. Satisfaction was assessed in 53 patients using a specific questionnaire: 51 (93%) of the patients reported that the phalloplasty allowed them to accord their physical appearance with their feeling of masculinity. There were flap complications in 14 patients (25%); three (5%) flaps were lost, with one each due to early haematoma, cellulitis and late arterial thrombosis. The other 11 flap complications were all transitory, e.g. infection, haematomas and vascular thrombosis. There were prosthesis complications in 11 of 38 patients (29%). Moreover, seven of 19 patients (37%) who had a urethroplasty presented with complex strictures and fistulae that led to perineal urethrostomy. CONCLUSION: Our study shows that phalloplasty with a forearm free-flap leads to good results in term of flap survival and patient satisfaction. However, there was a high rate of complications. Patients must be clearly informed that the procedure can seldom be achieved in one stage.

Blood pressure changes during sexual stimulation, ejaculation and midodrine treatment in men with spinal cord injury.

OBJECTIVES: To explore the effectiveness of various sources of self-stimulation, including oral midodrine, in triggering ejaculation in men with spinal cord injury (SCI), and to document the systematic variations in blood pressure at ejaculation and consider a revised definition of autonomic dysreflexia. PATIENTS AND METHODS: The study included 62 men with SCI lesions from C2 to L2. Ejaculation potential was assessed with various sources of stimulation, beginning with natural stimulation, followed, if the test was negative, by penile vibrator stimulation (PVS) followed, if the test was again negative, by PVS combined with oral midodrine, started at 5 mg and increased in 5 mg steps up to 25 mg. The success rate of ejaculation was recorded, as were blood pressure (BP) changes measured at baseline and at ejaculation (or on the last trial if the test was negative). Reported sensations were also recorded and compared during positive and negative tests. RESULTS: Overall, 89% of the patients reached ejaculation with one mode or another of stimulation. When patients had a negative result with natural stimulation, 56% were salvaged by PVS, and when PVS was negative, another 22% were salvaged by midodrine combined with PVS. The mean systolic BP increased by 35 mmHg at ejaculation during PVS and by 11 mmHg after midodrine, and a subsequent 29 mmHg at ejaculation during PVS combined with midodrine. By contrast, negative tests showed a relatively stable BP; the difference in changes in BP during positive and negative tests was significant (P < 0.01). Increases in BP during positive tests declined significantly more often within the limits of autonomic dysreflexia than negative tests (P < 0.01). CONCLUSION: These results support the view that most men with SCI can obtain an ejaculation when a wide spectrum of stimulation is used, including natural stimulation, PVS, and PVS combined with oral midodrine. Positive tests were associated with significant increases in BP, in contrast to negative tests, where BP was relatively stable. This suggests that significant changes in BP are required for ejaculation and that insignificant changes are predictive of future failure. As most changes in BP during positive tests also fall within the criterion of autonomic dysreflexia, a revised definition of autonomic dysreflexia should be considered to encourage safe experiences with ejaculation and safe use of midodrine.

Efficacy and safety of tadalafil in men with erectile dysfunction following spinal cord injury.

OBJECTIVE: To determine the efficacy and safety of tadalafil when taken on demand by men with erectile dysfunction (ED) secondary to traumatic spinal cord injury (SCI). DESIGN AND SETTING: Multicenter, randomized, double-blind, placebo-controlled, flexible dose-titration, parallel-group study in clinical practices in Europe. Patients Enrolled patients had ED secondary to SCI (all spinal levels) and sustained 6 months or longer before visit 1. INTERVENTIONS: After a 4-week run-in period, patients were randomly assigned to tadalafil, 10 mg, (n = 142) or placebo (n = 44) for a 12-week, on-demand treatment period with assessments at 4-week intervals. The dose of tadalafil was maintained or titrated (10 or 20 mg) at 4 and 8 weeks. MAIN OUTCOME MEASURES: Efficacy was measured using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ). Treatment-emergent adverse events and vital signs were collected at each visit. RESULTS: Mean age was 38 years. Mean baseline IIEF erectile function domain score was 13.4, and following 12 weeks of treatment, 22.6 for tadalafil and 13.6 for placebo (P < .001). After treatment, the tadalafil group compared with the placebo group was significantly greater (P < .001) in mean per-patient percentage of successful penetration attempts (SEP question 2; 75.4% vs 41.1%) and intercourse attempts (SEP question 3; 47.6% vs 16.8%); percentage of improved erections (GAQ question 1; 84.6% vs 19.5%); and ejaculatory frequency (IIEF question 9; P = .03). The 2 most common treatment-emergent adverse events in the tadalafil group compared with placebo were headache (8.5% vs 4.5%) and urinary tract infection (7.7% vs 6.8%). CONCLUSIONS: Tadalafil (10 mg and 20 mg) improved erectile function and was well tolerated by men with ED secondary to traumatic SCI.

[Chemical destruction of sacral nerve roots by alcohol injection for the treatment of overactive bladder]. / Destruction chimique des racines sacrées par injection d'alcool pour le traitement de l'hyperactivite vésicale.

INTRODUCTION: This study retrospectively reviewed the value of alcohol injection of sacral nerve roots after a lidocaine test in two indications: detrusor instability-detrusor hyperactivity syndrome and cystalgia. MATERIAL AND METHODS: Single-centre retrospective study from January 1992 to March 2003. Twenty-eight patients (1 man, 27 women) were admitted to the urology department for lidocaine test injection because of detrusor hyperactivity 24 cases (idiopathic = 13, neurological = 11), and cystalgia in another 4 cases. RESULTS: After the lidocaine test, infiltration of the sacral nerve roots (bilateral S3) by 70% alcohol was performed in 24/28 cases. The therapeutic effect was assessed at 1 month: 14 out of 24 patients reported that they were globally improved by the alcohol injection. The mean duration of the therapeutic effect was 3.8 months. In the longer term, only one of the 14 patients initially improved did not subsequently experience deterioration of the clinical features (with a follow-up of 8 months). A second alcohol injection was performed in 5/28 patients, with a positive result in only one case (4%). COMPLICATIONS: 6/24 (25%) patients developed lower limb pain that resolved over 2 to 3 months; 3/24 (12%) presented immediate postoperative urinary retention (that persisted in the long term in 1 case); 1/24 (4%) presented cicatricial anal incontinence. CONCLUSION: Alcohol injection of sacral nerve roots is a simple and inexpensive technique, but is associated with morbidity, and has inconstant and only transient effects. It can only be considered exceptionally in highly selected cases when no more effective treatments are available, such as botulinum toxin injection or sacral nerve root neuromodulation.

[Comparative study of the acceptability of the SpeediCath Set and Actreen set catheterization sets in patients performing self-catheterization]. / Etude d'acceptabilité du set de sondage SpeediCath Set comparativement à Actreen Set chez des patients pratiquant l'autosondage.

OBJECTIVE: To compare SpeediCath Set to Actreen Set in terms of performance, acceptability and safety, in patients performing self-catheterization. MATERIAL AND METHODS: Four questionnaires were completed during this multicentre, randomized, crossover study: initial, after having tested each of the two products and patient preference at the end of the study. RESULTS: Analysis was based on 29 men performing self-catheterization. The SpeediCath Set was found to be superior to the Actreen Set in terms of ease of introduction (p=0.0055), ease of emptying (p=0.0157), quality of lubricant (p<0.0001), urethral tolerance and possibility of catheterization in bed (p= 0.0157). The patients 'global assessment was clearly in favour of SpeediCath Set (70 +/- 2.3 versus 5.7 +/- 2.5; p=0.0156) and 65.5% of patients preferred to use SpeediCath Set in the future. CONCLUSION: SpeediCath Set facilitates catheterization and improves the urethral tolerance compared to Actreen Set, with a marked patient preference in favour of SpeediCath Set.

[REMEEX: A possible treatment option in selected cases of sphincter incompetence]. / REMEEX: une option thérapeutique envisageable dans des cas sélectionnés d'insuffisance sphinctérienne.

OBJECTIVE: To evaluate the functional results and morbidity of adjustable tension suburethral tape (REMEEX) in the treatment of urinary incontinence due to severe sphincter incompetence (MUCP < 40 cm H2O) in patients presenting a contraindication to artificial sphincter operated between December 2001 and May 2004. Twelve patients (66.7%) had already undergone incontinence surgery. Ten patients (55.5%) had mixed urinary incontinence. The efficacy of the tape was considered to be good when incontinence resolved completely, partial when incontinence was decreased by > 50% and/or PVR > 100 ml. All other cases were considered to be failures. In April 2005, after a mean follow-up of 26.3 months, retrospective evaluation of the functional results was performed by means of a pad-test and a questionnaire comprising an MHU (urinary disability) score and a Ditrovie score. Complications after each intercurrent event were recorded. RESULTS: The initial efficacy of the tape was considered to be good in 13 patients (72.2%) and partial in 4 patients (22.2%) with only one initial failure. Eight patients (44.4%) required secondary adjustment after a mean interval of 5.2 months, with a failure rate of 62.5%. In April 2005, 10 patients (55.5%) had a good result, 2 patients (11.1%) required self-catheterization (partial efficacy) and 6 patients (33.4%) were considered to be failures. In terms of morbidity, we observed 2 bladder injuries (11.1%), 6 superinfections of the device (33.3%), 2 (11.1%) of which required removal of the material. Fifteen patients (83.3%) answered the questionnaire: 6 patients (40%) had an MHU score greater than 3. The mean Ditrovie score was 2.1. 9 patients (60%) had a score less than 2 and 4 patients (26.6%) had a score greater than 3. CONCLUSION: The results of this series, in patients in whom artificial sphincter was contraindicated, are satisfactory at the price of acceptable morbidity. Before defining the place of this device in the range of treatment options for sphincter incompetence, our results must be confirmed by a longer series.

What is the optimum dose of type A botulinum toxin for treating neurogenic bladder overactivity?

OBJECTIVE: To assess the effects of two doses of botulinum toxin A (Dysport, Ipsen-Biotech, France; 500 and 1000 Speywood units, SU) injected into the bladder for treating incontinence due to a neurogenic overactive bladder. PATIENTS AND METHODS: In an open-label, prospective study between October 2002 and May 2004, in two centres, we analysed the effects of successive doses of 500 and 1000 SU of Dysport, endoscopically injected into the detrusor muscle. At each step, patients (26 women and 19 men) were re-evaluated at 1 month (clinical evaluation and pressure-flow study). If there was a 'good' clinical response (complete absence of urinary leakage) the patient was observed until incontinence recurred; otherwise a further injection was administered at a higher dose. RESULTS: The mean (sd, range) follow-up was 22 (0.75, 5-31) months; 11 of the 45 patients (24%) did not respond primarily at 1 month for both doses. The analysis of the two curves of survival with no re-injection of Dysport showed a statistically longer action at 1000 SU (P = 0.016). However, in this group there was one patient with general muscle weakness and asthenia, which could have been related to the injection. CONCLUSIONS: The optimum dose of Dysport for incontinence secondary to a neurogenic overactive bladder is not yet defined; 1000 SU probably has a more prolonged effect than 500 SU but exposes the patient to major complications. Further studies evaluating the clinical effect of 750 SU of Dysport are necessary.

Prevalence of erectile dysfunction among 7689 patients with diabetes or hypertension, or both.

OBJECTIVES: To survey the presence of, and attitudes toward, erectile dysfunction (ED) among patients with hypertension and/or diabetes mellitus who sought general medical care for any reason. METHODS: The abbreviated five-item version of the International Index of Erectile Function (IIEF-5) was used to determine the presence of ED. A patient questionnaire was used to assess attitudes about ED. RESULTS: We surveyed 7689 patients (mean +/- SD age 58.9 +/- 9.2 years), including 6719 (87%) in a stable sexual relationship. In patients with hypertension alone (n = 3906) and diabetes alone (n = 2377), ED was reported by 2379 (61%) and 1603 (67%) and was present in 2634 (67%) and 1677 (71%), respectively, as defined by an IIEF-5 score of less than 21. The corresponding mean scores were 12.0 (+/-4.6) and 11.5 (+/-4.6) in patients with ED and 20.5 (+/-3.6) and 20.2 (+/-3.8) in those without ED. Prevalence was affected by disease characteristics and history, and the number and type of antihypertensive medications. ED was reported by 924 (78%) of 1186 patients with both diseases and was present in 917 (77%) according to the IIEF-5 score. Overall, ED was reported by 5063 patients (66%) with hypertension and/or diabetes, was present in 5391 (70%) according to the IIEF-5 score, and increased in prevalence with age. ED was fairly to very bothersome in 4027 (80%) but untreated in 3312 (65%), of whom 2278 (69%) wanted treatment. Most of those wanting treatment would have welcomed discussion with their physician (1861 [82%] of 2278), and most wanted their physician to broach the subject (1292 [69%] of 1861). CONCLUSIONS: Our study results have shown that patients with diabetes and/or hypertension have a high prevalence of bothersome untreated ED and want their general practitioner to initiate a discussion and provide treatment.

[Two indications for bilateral neuromodulation]. / Neuromodulation bilatérale: à propos de deux cas.

The authors report two cases of patients presenting with complex voiding disorders treated successfully by bilateral neuromodulation. In the first patient, bilateral neuromodulation (left S2 and right S3) was indicated after failure of a first trial of conventional neuromodulation. In the second case, a complementary electrode in addition to the S3 electrode was placed at S1 to treat nerve root pain associated with urinary symptoms. The preoperative and postoperative findings are reported together with the course and possible explanations for the success of this treatment modality.