Multicenter randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence.

OBJECTIVES: To compare, in a multicenter, randomized clinical trial, collagen injections versus surgery with regard to efficacy, quality of life, satisfaction, and complications. METHODS: Of 133 women with stress urinary incontinence, 66 were randomized to collagen injection and 67 to surgery (6 needle bladder neck suspensions, 19 Burch, and 29 slings). After randomization, 15 women refused their allocated treatment. "Intent-to-treat" and "per protocol" analyses were applied. Women assigned to collagen injection could receive up to three injections before it was considered a failure. A "top-up" injection was allowed within 3 months after cure. Success as the primary outcome at 12 months was defined as a dry 24-hour pad test (2.5 g or less of urine) after having received only the allocated intervention. RESULTS: The per protocol analysis showed that the success rate 12 months after collagen injections (53.1%) was much lower than that after surgery (72.2%). The difference was 19.1% (95% confidence interval -36.2% to -2%). The general and disease-specific quality-of-life scores measured by the Rand Medical Outcomes Study 36-item Health Survey and Incontinence Impact Questionnaire were similar in the two groups (P = 0.306). Women treated by surgery were, on average, more satisfied (79.6%) than those treated by collagen injection (67.2%), but the difference was not significant (P = 0.228). Finally, complications were less frequent and severe with collagen injection: 36 events in 23 subjects for collagen injection versus 84 events in 34 subjects for surgery (P = 0.03). CONCLUSIONS: One year after intervention, the success rate of collagen injection as a treatment for stress urinary incontinence was about 19% lower than that after surgery. This has to be tempered by the similar changes in quality of life and satisfaction in both groups and that the number and severity of complications were much greater after surgery than after collagen injection. The results of this study indicate that collagen injections might be a worthwhile alternative to surgery for the treatment of stress urinary incontinence.

Long-term effectiveness of sacral nerve stimulation for refractory urge incontinence.

OBJECTIVES: To evaluate the long-term efficacy of sacral nerve stimulation for refractory urinary urge incontinence. STUDY DESIGN AND METHODS: Urge incontinent patients qualified for surgical implantation of a neurostimulator system after trial screening with percutaneous test stimulation. Surgical implantation of the InterStim System (Medtronic Inc., Minneapolis, Minn., USA) was performed in cases where a >50% reduction in incontinence symptoms was documented during the 3- to 7-day test stimulation period. The InterStim System consists of an implantable pulse generator, a transforamenally placed quadripolar lead, and an extension that connects these two devices for unilateral stimulation of the S3 or S4 sacral nerve. Efficacy for 96 implanted patients was based on urinary symptom changes as quantified in voiding diaries collected at baseline and annually after surgical implantation. RESULTS: As compared to baseline, the group of 96 implanted patients demonstrated significant reductions in urge incontinent symptoms at an average of 30.8+/-14.8 (range 12-60) months with respect to the number of urge incontinent episodes per day, severity of leaking, and the number of absorbent pads/diapers replaced per day due to incontinence (all p<0.0001, respectively). Gender, pretreatment variables, and age were not found to be relevant factors that affected these results. 11 of the 96 patients underwent device explant due to lack of efficacy, pain or bowel dysfunction. These data were conservatively included in the efficacy results. No permanent injuries associated with the devices or therapy were reported. CONCLUSION: Sacral nerve stimulation is an effective treatment for refractory urge incontinence with sustained long-term benefit through an average of 30.8 months.

Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation.

PURPOSE: We investigate the efficacy of sacral neurostimulation in patients with idiopathic urinary retention in a prospective, randomized multicenter trial. MATERIALS AND METHODS: A total of 177 patients with urinary retention refractory to standard therapy were enrolled in the study. Greater than 50% improvement in baseline voiding symptoms during a 3 to 7-day percutaneous test stimulation qualified a patient for surgical implantation of an InterStim parallel system. Of the patients who qualified for implantation 37 were randomly assigned to a treatment and 31 to a control group. Patients in the treatment group underwent early surgical implantation of the sacral nerve stimulation system, while implantation was delayed in the control group for 6 months. Followup evaluations, including voiding diary analysis and temporary deactivation of the stimulator at 6 months, were conducted at 1, 3, 6, 12 and 18 months after implantation in the treatment group, and after 3 and 6 months in the control group. RESULTS: Compared to the control group, patients implanted with the InterStim system had statistically and clinically significant reductions in the catheter volume per catheterization (p <0.0001). Of the patients treated with implants 69% eliminated catheterization at 6 months and an additional 14% had a 50% or greater reduction in catheter volume per catheterization. Therefore, successful results were achieved in 83% of the implant group with retention compared to 9% of the control group at 6 months. Temporary inactivation of sacral nerve stimulation therapy resulted in a significant increase in residual volumes (p <0.0001) but effectiveness of sacral nerve stimulation was sustained through 18 months after implant. CONCLUSIONS: Results of this prospective, randomized clinical study demonstrate that sacral nerve stimulation is effective for restoring voiding in patients with retention who are refractory to other forms of treatment.

Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency, and retention.

Many patients have chronic, debilitating symptoms of voiding dysfunction that are refractory to conventional medical or surgical therapies. This multicenter, prospective study evaluated the long-term effectiveness of sacral nerve stimulation using the implantable Medtronic InterStim therapy for urinary control in patients with otherwise intractable complaints of urinary urge incontinence, urgency-frequency, or retention. Each patient first underwent temporary, percutaneous sacral nerve test stimulation. If at least a 50% reduction in target symptoms was documented for at least 3 days, patients received a permanent Medtronic InterStim sacral nerve stimulation system that includes a surgically implanted lead and neurostimulator. Regular follow-up was conducted with outcome data. We report here on patients who have been observed from 1.5 to 3 years postimplantation. The results demonstrate that after 3 years, 59% of 41 urinary urge incontinent patients showed greater than 50% reduction in leaking episodes per day with 46% of patients being completely dry. After 2 years, 56% of the urgency-frequency patients showed greater than 50% reduction in voids per day. After 1. 5 years, 70% of 42 retention patients showed greater than 50% reduction in catheter volume per catheterization. We conclude that the Medtronic InterStim therapy for urinary control system is an effective therapy with sustained clinical benefit for patients with intractable symptoms of urinary urge incontinence, urgency-frequency, or retention.

Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety.

PURPOSE: Neuromodulation of sacral nerves has shown promising results in correcting voiding dysfunction. We report the results of a multicenter trial designed to assess the efficacy of sacral nerve neuromodulation in patients presenting with refractory urinary urgency-frequency. MATERIALS AND METHODS: A total of 51 patients from 12 centers underwent baseline assessment, including a detailed voiding diary, urodynamic evaluation and percutaneous test stimulation of the sacral nerves at S3 and/or S4. All patients enrolled in the study had undergone prior conventional treatment, such as pharmacotherapy, hydrodistention and surgical intervention, which failed. All patients demonstrated a satisfactory response to trial stimulation and were randomly divided into a stimulation group (25 patients) and a control group (26). A sacral nerve stimulation device was implanted after 6 months in the control group. Patients were followed at 1, 3 and 6 months, and at 6-month intervals for up to 2 years after implantation of a neuroprosthetic InterStim* system. dagger The study variables included the number of voids daily, volume voided per void and degree of urgency before void. RESULTS: Compared to the control group, 6-month voiding diary results demonstrated statistically significant improvements (p <0.0001) in the stimulation group with respect to the number voids daily (16.9 +/- 9.7 to 9.3 +/- 5.1), volume per void (118 +/- 74 to 226 +/- 124 ml.) and degree of urgency (rank 2.2 +/- 0.6 to 1.6 +/- 0.9). Patients in the control group showed no significant changes in voiding parameters at 6 months. Significant improvements in favor of the stimulation group were noted in various parameters with respect to water cystometry and quality of life (SF-36). At 6 months after implant, neurostimulators were turned off in the stimulation group and urinary symptoms returned to baseline values. After reactivation of stimulation sustained efficacy was documented at 12 and 24 months. CONCLUSIONS: Neuromodulation of the sacral nerves is an effective, safe therapy that successfully treats significant symptoms of refractory urgency-frequency.

Removal of UroLume endoprosthesis: experience of the North American Study Group for detrusor-sphincter dyssynergia application.

PURPOSE: We present the experience of the North American UroLume Multicenter Study Group with removal of the UroLume endoprosthesis. MATERIALS AND METHODS: A total of 160 neurologically impaired patients were enrolled in the North American UroLume Multicenter Study Group for detrusor external sphincter dyssynergia application. Analysis was performed in 2 groups of patients in which the device was removed during insertion and after implantation, respectively. RESULTS: Device retrieval was required during insertion in 21 patients (13%) mainly due to misplacement or migration in 17. Extraction was done with minimal complications and in all but 2 cases subsequent UroLume implantation was successful. Of 158 men with the device in place 31 (19.6%) required removal. In 34 procedures 44 devices were removed, mainly due to migration. Time from implantation to removal ranged from 4 days to 66 months (mean 22 months). The UroLume was removed en bloc in 20 cases and in parts or wire by wire in 19. The majority of patients had no or minimal complications after extraction. Only 2 patients had serious temporary complications, including bleeding and urethral injury, with no lasting consequences. No malignancy developed as a result of UroLume insertion. CONCLUSIONS: While there is a potential for urethral injury and bleeding, UroLume endoprosthesis removal is largely a simple procedure with minimal complications and consequences.

Long-term results and complications of augmentation ileocystoplasty for idiopathic urge incontinence in women.

OBJECTIVE: To assess the long-term (3-9 years) results of augmentation ileocystoplasty for non-neurogenic female urge incontinence in terms of continence, the need for intermittent self-catheterization and the need for additional or auxiliary treatment, to define the long-term complications and to assess the patients' satisfaction with the outcome. PATIENTS AND METHODS: The study comprised 51 women who underwent augmentation ileocystoplasty for non-neurogenic urge incontinence between November 1987 and December 1993; 27 patients had associated interstitial cystitis. All patients had exhausted conservative methods, with an unsatisfactory outcome. All patients were interviewed about the results of the procedure, and their charts reviewed and updated with relevant information. RESULTS: Within a mean (range) follow-up of 75.4 (36-109) months, 27 patients (53%) were completely continent, 13 (25%) had occasional leaks and nine (18%) continued to have disabling urge incontinence frequently requiring pads. Regular self-catheterization was needed by 20 (39%) patients while the rest emptied adequately with no or minimal residual volumes. Additional pharmacotherapy had to be used by 12 (24%) patients. Three patients later developed stress urinary incontinence and were managed with fascial sling procedures. The patch was revised in two patients and excised from four others because they had high residual volumes and uncontrollable infections. Two patients had an ileal conduit diversion for persistent incontinence. The most common complication was recurrent urinary tract infections, seen in 22 patients using intermittent self-catheterization. Mucus retention occurred regularly in 10 patients, six had chronic diarrhoea, four had latent bowel obstruction, one developed a bladder stone, one an incisional hernia and one developed patch necrosis and perforation. Twenty-seven patients (53%) were happy with the outcome of the procedure while 20 (39%) were not; four patients were unsure whether a change had occurred. CONCLUSION: Augmentation ileocystoplasty is a valuable alternative for women with intractable urge incontinence. However, these patients and their physicians should be aware of its limitations, specifically the possibility that incontinence may persist and the high probability of the need for self-catheterization, with potential subsequent urinary tract infection.

Using the ICSOoL to measure the impact of lower urinary tract symptoms on quality of life: evidence from the ICS-'BPH' Study. International Continence Society--Benign Prostatic Hyperplasia.

OBJECTIVE: To present and describe the validity and reliability of the International Continence Society-Benign Prostatic Hyperplasia study quality-of-life (ICSQoL) instrument, a new set of questions to assess the impact of lower urinary tract symptoms (LUTS) on quality of life (QoL) in middle-aged and elderly men. PATIENTS AND METHODS: The study comprised 1271 consecutive men over the age of 45 years, attending urology departments in 12 countries, with LUTS and possible benign prostatic obstruction who were recruited to the ICS-'BPH' study (the clinic group); 423 ambulant men were recruited from a general practice in the UK to provide a community group. Each individual completed the ICS-'BPH' study questionnaire which includes six items addressing general and specific aspects of QoL (the ICSQoL). Content and construct validity were assessed by interviews with patients and by testing hypotheses within the study groups, e.g. the relationships with age, individual LUTS (as measured on the ICSmale questionnaire) and generic health status, as measured by the Short Form (SF-36) and EuroQol instruments. Reliability was assessed by measures of internal consistency and a test-retest analysis. RESULTS: The ICSQoL items were easily understood by patients, were completed with low levels of missing data, and address some (but not all) concerns about the impact of LUTS on QoL. The ICSQoL items have good construct validity, showing expected differences between community and clinic samples, and expected relationships with each other and individual LUTS. Items had good test-retest reliability, but their internal consistency was poor, confirming that ICSQoL questions should not be combined into a score. General ICSQoL items were closely related with most domains of the SF-36 and the EuroQol. CONCLUSION: ICSQoL items may be used individually or as a group in research studies or in clinical practice.

Modulation of feline bladder and distal urethral responses to dorsal sacral root stimulation by intrathecal administration of a kappa 1-opioid agonist.

OBJECTIVES: We examined bladder and distal urethral responses to sacral dorsal root (SDR) electrostimulation with simultaneous intrathecal administration of a kappa 1-opiate agonist. METHODS: Experiments were conducted on 14 spinally intact and 6 chronic spinally transected decerebrated mongrel cats. In the chronically spinalized cats, midthoracic complete spinal cord transection was performed 6 to 8 weeks before the electrostimulation experiments. Sympathetic denervation was carried out by cutting the sympathetic chain and the hypogastric nerve bilaterally. Proximal ends of the cut S1-3DR were stimulated, and bladder pressure and urethral perfusion pressure changes were recorded before and after drug administration. RESULTS: The S2DR electrostimulation in spinally intact cats produced the best vesical contraction, but with dyssynergic urethral response. The magnitude and the pattern of the response changed with the different stimulation parameters. U-50,488H, a selective kappa 1-opiate receptor agonist, decreased significantly the bladder and the urethral responses to S2DR stimulation in spinally intact but not in chronic spinally transected cats. Nor-BNI, a kappa antagonist, reversed these responses in spinally intact cats. CONCLUSIONS: Our results showed that it is feasible to produce bladder contraction with SDR stimulation and suggest that kappa 1 receptors may have a role in bladder and distal urethral reflexes at the suprasacral level.

Idiopathic reduced bladder storage versus interstitial cystitis.

Idiopathic reduced bladder storage is a term we used to describe a group of patients who have subjective and objective evidence (by cystometrogram) of diminished bladder capacity without a demonstrable cause. We performed a prospective study comparing this condition with interstitial cystitis. We studied the clinical, urodynamic and histological features, and response to therapy in these 2 groups of patients. No statistical difference was found between the incidence of irritative bladder symptoms and/or suprapubic pain. Only minor differences were noted in the maximum cystometric capacity and incidence of bladder instability. Histological and immunofluorescent features were analogous. Also, the reduced bladder storage and interstitial cystitis patients responded similarly to bladder dilation and pharmacological therapy. Augmentation ileocystoplasty used in patients refractory to medical treatment produced comparable results in the short term. Based upon similar findings, it is likely that these 2 conditions represent the same disease entity with the only difference being the cystoscopic findings.

Final diagnosis and therapeutic implications of mixed symptoms of urinary incontinence in women.

The final diagnosis of 244 females who presented with mixed symptoms of stress incontinence (SI) and urge incontinence (UI) was made based on clinical, urodynamic, and cystoscopic findings. The UD studies consisted of cystometrogram, uroflow and urethral pressure profiles in the supine and standing positions. Diagnosis of genuine stress urinary incontinence (GSI) in 72 patients (30%) was based on the presence of positive Marshall test result or maximum urethral closure pressure 40 cm of water or less, in addition to the symptoms of stress incontinence. Diagnosis of reduced bladder storage (RBS) in 36 patients (15%) was based on MCC 300 mL or less, or the findings of bladder instability on cystometrogram in addition to the symptoms of urge incontinence. Ninety-five patients (39%) with the criteria of both GSI and RBS were classified as the mixed group. The diagnosis of interstitial cystitis in 19 patients (8%) was made according to the criteria outlined by Messing. Urethral stenosis was diagnosed in 6 patients (2%) based on a reduced maximal flow rate by at least 2 S.D. and a tight urethra to F16 calibration at cystoscopy. Sixteen patients (7%) with inconclusive diagnosis had symptoms only of SI and UI but no objective findings. The clinical and urodynamic findings in each group and the results of the surgical and medical treatment are compared.

Analysis of imaging modalities, staging systems, and prognostic indicators for renal cell carcinoma.

A retrospective analysis of 314 patients with renal cell carcinoma was done focusing mainly on imaging modalities and prognostic significance of tumor stage using both the Robson and TNM systems. Computerized tomography (CT) scan proved to be the most effective modality for staging. Overall staging accuracy was 62 and 68 percent for TNM and Robson staging, respectively, and understaging was more frequent than overstaging. The actuarial five-year survival using the Robson system was 73 percent for Stage A, 68 percent Stage B, 51 percent Stage C, and 20 percent Stage D. The main limitation of the Robson system is the heterogeneity of the Stage C group which includes patients with renal vein and those with nodal involvement with a significant difference in survival. The survival by the TNM system showed no difference in those with T1, T2, T3a and T3b disease but a significant difference in those with T3c or T4a. One hundred sixteen patients (37%) presented with metastatic disease with a median survival of seventeen months (range 2-204) for those with solitary metastasis and six months (range 1-132) for those with multiple metastases (the difference was not statistically significant). Except for anecdotal cases, nephrectomy with or without treatment of the metastases did not seem to affect survival significantly. The presence of spindle cell, alone or in association with clear or granular cell, affected the prognosis adversely. Thirty-one patients had their tumors identified incidentally. Their stage at diagnosis was earlier than the symptomatic group (Stage T1-T2: 77% vs 34%), and there was a significant difference in the disease-free survival at fifty-four months between the two groups (79% vs 57%, respectively).

Alpha 2-adrenoceptors not imidazole receptors mediate depression of a sacral spinal reflex in the cat.

In chloralose-anaesthesized cats, clonidine, an alpha 2-adrenoceptor agonist with an imidazole ring, depressed pudendal nerve reflex activity. Clonidine's inhibitory action on this compound action potential response was mimicked by guanabenz, a non-imidazole alpha 2-adrenoceptor agonist, and was reversed by SK & F 86466, a non-imidazole alpha 2-adrenoceptor antagonist. These results imply that clonidine's action on this reflex related to urinary sphincter function is mediated by alpha 2-adrenoceptors and is not dependent on an imidazole structure.

Oxybutynin versus propantheline in patients with multiple sclerosis and detrusor hyperreflexia.

Hyperreflexia is the most common urological finding in patients with multiple sclerosis. A prospective randomized study was done to compare the effectiveness of 2 commonly used drugs, oxybutynin and propantheline. Of the 34 patients entered into the trial 19 were treated with oxybutynin and 15 with propantheline. The urological symptoms (frequency, nocturia, hesitancy, urgency and urge incontinence) were graded according to severity from 0 to 3. Patients with urinary infection were excluded. Urodynamic examination, consisting of cystometrography and electromyography, was performed in all patients before treatment. Both groups of patients had comparable neurological, urological and urodynamic status before treatment. In 4 patients (21 per cent) treated with oxybutynin and in 4 (27 per cent) treated with propantheline side effects were so severe that the treatment had to be discontinued. Symptomatic response to oxybutynin was good in 10 patients (67 per cent), fair in 2 (13 per cent) and poor in 3 (20 per cent). Propantheline produced good symptomatic results in 4 patients (36 per cent), fair in 1 (9 per cent) and poor in 6 (55 per cent). The mean increase in maximum cystometric capacity on cystometrography was significantly larger in the oxybutynin group than in the propantheline group (144 +/- 115 versus 35 +/- 101). Our results indicate that oxybutynin is more effective than propantheline in the treatment of detrusor hyperreflexia in patients with multiple sclerosis.

Relationship between neurological and urological status in patients with multiple sclerosis.

The relationship between neurological urinary symptoms and urodynamic findings in patients with multiple sclerosis was examined. The duration of multiple sclerosis was significantly longer in patients with urinary symptoms. The presence of urinary symptoms correlated with the severity of the pyramidal or sensory lesions and the total disability score. Cystometrograms revealed detrusor hyperreflexia in 67 per cent of the patients, areflexia in 21 per cent and a normal detrusor in 12 per cent. Somatic dyssynergia was found in 20 of the 39 patients whose examination revealed clear-cut results. Positive correlation was found between urge incontinence and detrusor hyperreflexia, and between hesitancy and detrusor areflexia but no relationship was found between urological symptoms and sphincter function. Analysis of the neurological lesions in relation to the cystometric findings revealed a positive correlation among pyramidal lesions, detrusor hyperreflexia and detrusor areflexia, and between cerebellar lesions and detrusor areflexia. The correlation between detrusor dysfunction and high total disability score disappeared when patients with high pyramidal scores were excluded. No correlation could be detected between somatic dyssynergia and the various neurological lesions.