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Biomedical subjects

Roger R Dmochowski

Publications and source records attributed to Roger R Dmochowski.

At least 19 recordsLinked to original sources
PubMed2003

Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence.

OBJECTIVES: To compare the efficacy and safety of an oxybutynin transdermal delivery system (OXY-TDS) and oral, long-acting tolterodine (TOL-LA) with placebo in previously treated patients with urge or mixed urinary incontinence. METHODS: After withdrawal of their current antimuscarinic therapy, 361 adult patients were randomized to 12 weeks of double-blind, double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day, daily TOL-LA 4 mg, or placebo. Evaluations included change from baseline in patient urinary diary symptoms, incontinence-specific quality of life, and safety. RESULTS: OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes (median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo; P <0.05), increased the average void volume (median change 24 and 29 mL versus 5.5 mL, P <0.01), and improved quality of life (incontinence impact questionnaire [IIQ] total score, P <0.05; Urogenital Distress Inventory Irritative Symptom subscale, P <0.05) compared with placebo. The most common adverse event for OXY-TDS was localized application site pruritus (14% versus 4% placebo) accompanied by a low incidence of systemic side effects (eg, dry mouth 4.1%). Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment (dry mouth 7.3% versus 1.7% placebo, P <0.05). CONCLUSIONS: OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence. OXY-TDS improves systemic safety with regard to anticholinergic side effects. Local skin irritation occurs in some OXY-TDS patients.

Administration, Cutaneous↗
PubMed2003

Repeat urethrolysis after failed urethrolysis for iatrogenic obstruction.

PURPOSE: Bladder outlet obstruction is a potential complication of all stress incontinence surgery. Urethrolysis successfully relieves 65% to 93% of cases. We determined the success of repeat urethrolysis after failed initial urethrolysis to relieve obstruction. MATERIALS AND METHODS: We reviewed the charts of 24 women who underwent repeat urethrolysis for iatrogenic obstruction after at least 1 previous attempt. Aggressive repeat urethrolysis was performed via a retropubic or transvaginal route depending on the clinical scenario and surgeon discretion. Outcomes measured were patient ability to void spontaneously without catheterization, decreased post-void residual urine and resolution of lower urinary tract symptoms, particularly urge incontinence. RESULTS: Mean patient age was 55 years (range 38 to 80). The initial incontinence procedure was a pubovaginal sling in 10 cases, retropubic suspension in 9, needle suspension in 4 and anterior colporrhaphy in 1. A total of 23 patients had previously undergone transvaginal urethrolysis, while 1 had undergone retropubic urethrolysis. The repeat procedure was retropubic in 12 women (50%), transvaginal in 10 (42%) and combined in 2 (8%). Mean time between initial and repeat urethrolysis was 9 months (range 1 to 3). Mean followup was 14 months. Postoperatively 20 of the 22 patients (91%) who were catheter dependent no longer needed to catheterize. Post-void residual urine normalized in the 2 patients who had not been catheter dependent but who had had elevated post-void residual urine. Thus, repeat urethrolysis successfully eliminated urinary retention in 22 of the 24 cases (92%). Mean post-void residual urine before and after repeat urethrolysis was 334 versus 44 ml. (p <0.001). Irritative symptoms and urge incontinence completely resolved in 12% of cases, were improved and required medication in 69% and remained the same in 19%. No patient had new onset irritative symptoms. Stress urinary incontinence recurred in 4 of the 22 women (18%) and persisted in the 2 in whom it had been present before urethrolysis. CONCLUSIONS: Aggressive repeat urethrolysis can be highly successful for relieving iatrogenic retention. Complete resolution of irritative symptoms and urge incontinence is less likely. Recurrent stress urinary incontinence is similar to that after primary urethrolysis.

Adult↗
PubMed2003

Transvaginal radio frequency treatment of the endopelvic fascia: a prospective evaluation for the treatment of genuine stress urinary incontinence.

PURPOSE: We evaluate the safety and efficacy of a new treatment modality for genuine stress urinary incontinence which was a transvaginal radio frequency applicator to deliver radio frequency energy to the endopelvic fascia. The purported mechanism of effect for this therapy is shrinkage of the collagenated tissue which composes the endopelvic fascia that supports the bladder neck and proximal urethra, thus stabilizing the proximal urethra and bladder neck. In prior animal trials and early pilot studies this therapy was shown to cause a reproducible thermal effect manifested by fascial shrinkage. Preliminary human trials indicated a therapeutic benefit of this therapy for women with genuine stress urinary incontinence. MATERIALS AND METHODS: To our knowledge this is the first multicenter study of a transvaginal approach for radio frequency of the endopelvic fascia for treatment of genuine stress incontinence. Between June 1999 and June 2000, 120 consecutive women (mean age 49.9 years) at 10 sites underwent transvaginal radio frequency treatment in a prospective trial to evaluate the overall efficacy and safety profile of this therapy. All patients had preoperative urethral hypermobility (average cotton swab change 38 degrees). Detrusor instability was excluded by cystometry. In all procedures precisely controlled radio frequency energy was applied to the endopelvic fascia to heat and shrink the tissue. The patients were evaluated postoperatively at 1 week and at 1, 3, 6 and 12 months using objective and subjective measures. Primary end points consisted of physician assessment of continence, patient reported pad use and the number of patient reported episodes. Safety was determined for acute (immediate postoperative) and chronic time frames. RESULTS: Of the 120 patients 96 completed 1-year evaluation. Average operative time was less than 30 minutes, and all patients were treated as outpatients. Preoperatively 101 patients (84%) averaged 1 or more episodes of urinary incontinence per day. At 3, 6 and 12 months 57%, 66% and 59% of patients, respectively, averaged 1 or no daily episodes of urinary incontinence. At 12-month followup 79 of 109 patients (73%) reported being continent or improved. Preoperatively, 43% of patients reported using 1 or no pads daily. At 3, 6 and 12 months 69%, 70% and 72% of patients, respectively, required 1 or no pads daily. On urodynamic evaluation at 12-month followup 76.0% of the patients did not leak with a Valsalva maneuver. A total of 30 cases were classified as failures and 11 women were lost to followup. There were no intraoperative complications, 3 (4%) minor postoperative complications which resolved, and no device related complications. CONCLUSIONS: The transvaginal radio frequency applicator demonstrated good efficacy and excellent safety at 1-year followup. Ongoing analysis of the data has indicated opportunities for improvement of this new surgical technique that could result in higher efficacy rates without compromising safety. Further long-term evaluation is being conducted to assess chronic durability of the procedure.

Catheter Ablation↗
PubMed2003

Urodynamic patterns following ischemic spinal cord events.

PURPOSE: The nature of bladder function following ischemic injuries to the spinal cord (vSCI) is poorly understood. We describe urodynamic (UD) findings in patients with vSCI and determined the optimal management of voiding dysfunction. MATERIALS AND METHODS: From January 1997 through September 2001, 18 patients were diagnosed with vSCI. All underwent neurological and urodynamic evaluation. The etiology of vSCI was abdominal aortic aneurysm repair in 10 patients, another surgical procedure in 4 and a spontaneous spinal cord infarct in 2. RESULTS: Two patients (American Spinal Injury Association [ASIA] class A) had detrusor areflexia or hyporeflexia and performed clean intermittent catheterization. Of the 10 patients assigned to ASIA class C 50% had UD evidence of abnormal compliance, unstable detrusor contractions and detrusor-external sphincter dyssynergia (DESD). All 10 patients had thoracic or cervical sensory levels and 60% had detrusor hyporeflexia or areflexia. A single patient voided spontaneously, while the remainder performed continuous or intermittent catheterization. Five patients assigned to ASIA class D had no abnormal compliance, unstable detrusor contractions or DESD. Four patients voided spontaneously or by abdominal straining. The patients with a history of abdominal aortic aneurysm repair were a heterogeneous population. CONCLUSIONS: While the etiology or sensory level of vSCI does not appear to predict UD patterns with consistency, greater preservation of motor function may be associated with improved parameters. All patients with vSCI and lower urinary tract symptoms require thorough UD evaluation and ongoing surveillance is mandated because deterioration may develop with time. Clean intermittent catheterization may represent the most effective method of bladder emptying for patients unable to void voluntarily. However, early evidence of abnormal compliance and DESD has also been seen in these patients, underscoring the need for close UD surveillance.

Aged↗
PubMed2003

Antibiotic prophylaxis in urologic prosthetic surgery.

The implantation of prosthetic devices is an ever-increasing practice in urologic surgery. The most common devices are penile prostheses, artificial urinary sphincters, synthetic pubovaginal slings, and bone anchors used for pelvic floor reconstruction and incontinence surgery. While their efficacy has been supported over time, infection and rejection are severe complications. Explantation of the entire prosthetic device has been the standard treatment of such complications, often necessitating long-term antibiotics and prolonged recovery before future reimplantation. The dense inflammatory response associated with prosthetic surgery may obliterate tissue planes and further complicate reoperative efforts. These factors support the need for effective antibiotic prophylaxis, with the goal of preventing bacterial seeding of the prosthesis during implantation. Antibiotic regimens should be effective against biofilm-forming bacteria, especially S. epidermidis and P. aeruginosa, and vancomycin should be a mainstay. Prevention of intraoperative infection by treating existing skin and urinary tract reservoirs and employing strict sterile technique cannot be overemphasized. While data is scant, it appears that routine prophylaxis prior to dental procedures, in patients with urologic prostheses, is unwarranted; however, if the patient is immunocompromised or has severe comorbidities, prophylaxis should be employed.

Animals↗
PubMed2003

Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial.

OBJECTIVE: To compare the efficacy and tolerability of extended-release formulations of oxybutynin chloride and tolterodine tartrate in women with overactive bladder. PATIENTS AND METHODS: The OPERA (Overactive bladder: Performance of Extended Release Agents) trial was a randomized, double-blind, active-control study performed at 71 US study centers from November 21, 2000, to October 18,2001. Extended-release formulations of oxybutynin at 10 mg/d or tolterodine at 4 mg/d were given for 12 weeks to women with 21 to 60 urge urinary incontinence (UUI) episodes per week and an average of 10 or more voids per 24 hours. Episodes of UUI (primary end point), total (urge and nonurge) incontinence, and micturition were recorded in 24-hour urinary diaries at baseline and at weeks 2, 4, 8, and 12 and compared. Adverse events were also evaluated. RESULTS: Improvements in weekly UUI episodes were similar for the 790 women who received extended-release formulations of oxybutynin (n = 391) or tolterodine (n = 399). Oxybutynin was significantly more effective than tolterodine in reducing micturition frequency (P = .003), and 23.0% of women taking oxybutynin reported no episodes of urinary incontinence compared with 16.8% of women taking tolterodine (P = .03). Dry mouth, usually mild, was more common with oxybutynin (P = .02). Adverse events were generally mild and occurred at low rates, with both groups having similar discontinuation of treatment due to adverse events. CONCLUSIONS: Reductions in weekly UUI and total incontinence episodes were similar with extended-release formulations of oxybutynin and tolterodine. In the oxybutynin group, micturition frequency was significantly lower, and the percentage of women reporting no urinary incontinence episodes was significantly higher compared with the tolterodine group. Dry mouth was more common with oxybutynin, but tolerability was otherwise comparable, including adverse events involving the central nervous system.

Administration, Oral↗
PubMed2002

Questionnaires for women with urinary symptoms.

AIMS: To identify the characteristics of optimal symptom questionnaires in women with lower urinary tract symptoms (LUTS). METHODS: Literature review. RESULTS: Although numerous questionnaires have been developed for the evaluation of female LUTS, no one instrument has emerged as that preferred for collecting and reporting subjective information about LUTS in women. Questionnaires currently available range widely in intended purpose, extent and style, and in the quality of testing used to validate them. CONCLUSIONS: Questionnaires should be constructed based on scientifically sound validation techniques that reflect disease and/or symptoms in the target population. They should be concise, easily administered and scored, discriminant between sphincter and bladder causes of incontinence, and able to measure severity and the effect of the symptom on the patient.

Female↗
PubMed2002

Radiofrequency bladder neck suspension for the treatment of genuine stress urinary incontinence.

Radiofrequency energy has been used for numerous medical applications including orthopedic, oncologic, and ophthalmologic indications. Characteristics of this energy source also allow it to be used for precisely controlled thermal therapy directed at soft tissues so as to induce such changes as collagen deposition and tissue shrinkage. These soft tissue effects have recently been used for the treatment of genuine stress urinary incontinence in women. As experience with this modality has matured, improved and less invasive methods of energy application have been developed. Large-scale clinical trials using this energy modality via laparoscopic and transvaginal approaches have either recently been completed or are near completion. A completely noninvasive approach is presently undergoing early clinical trials. The efficacy and safety profiles of this therapy support radiofrequency treatment of the endopelvic fascia as an option for the management of stress urinary incontinence in women.

Catheter Ablation↗
PubMed2002

Advances in drug delivery: improved bioavailability and drug effect.

Alterations in drug delivery produce substantial changes in the bioavailability of anticholinergic agents. These bioavailability differences change the efficacy and tolerability of this drug class, which consistently enhances patient compliance and overall drug effect. In order for drug delivery to alter successfully the bioavailability of a specific agent, the metabolism of that agent and the effect of the degradatory pathway on drug-parent compound levels need to be established. This will enable researchers to design improved or altered delivery pathways to maximize the benefits of these agents. Intestinal metabolism is known to affect certain agents, specifically oxybutynin chloride. Therefore, delivery techniques have been designed that either substantially lower or totally bypass intestinal (presystemic) metabolism. These alternate paths include extended-release oral, cutaneous, intravesical, and intravaginal routes. In addition, improvements in drug delivery have also been found to influence positively efficacy and tolerability profiles associated with tolterodine tartrate, another anticholinergic agent. A long-acting oral formulation has been shown to increase drug efficacy while decreasing tolerability concerns and side effects such as xerostomia. These salubrious effects are, in part, due to the more stable serum-drug concentrations that are imparted by this long-acting formulation.

Biological Availability↗
PubMed2002

Pubic osteomyelitis following bladder neck surgery using bone anchors: a report of 9 cases.

PURPOSE: We reviewed 9 cases of pubic osteomyelitis associated with placement of bone anchors for bladder neck suspension procedures for risk factors, bacterial speciation and sensitivities, and interventions performed. MATERIALS AND METHODS: Nine women were treated for pubic osteomyelitis following the use of bone anchors for bladder neck suspension surgery. In 8 cases the bone anchors had been placed through a suprapubic incision and in 1 the bone anchors were placed by a vaginal route. RESULTS: Patient ages ranged from 36 to 74 years (mean 51.8). Symptomatic presentation ranged from 2 to 18 months following initial operation. Presenting symptoms included pain over the pubis and/or a draining wound. Staphylococcus species were cultured in all cases, most commonly Staphylococcus epidermidis. Resistance to methicillin was present in 7 cases (78%). Wound débridement and removal of the anchors provided definitive treatment in all but 1 patient, who eventually required partial pubectomy. Pain (3 of 9 cases) and mild incontinence (5 of 9) were present at last followup. CONCLUSIONS: Bone anchors used in surgery for urinary incontinence can be associated with pubic osteomyelitis. Infection characteristics are similar to those seen with other urological prosthetic implantation procedures. Aggressive treatment with surgical débridement and long-term antibiotics is usually effective. Staphylococcus species, especially methicillin resistant strains, are the most common bacteria identified in this setting. Careful attention to implantation technique, including appropriate perioperative antibiotic selection, should be considered when using this technique.

Adult↗
PubMed2002

Early results of pubovaginal sling lysis by midline sling incision.

OBJECTIVES: To describe a simplified technique and results of pubovaginal sling lysis by incision of the sling in the midline by way of a transvaginal approach. METHODS: We reviewed the charts of 19 women who underwent pubovaginal sling lysis for obstruction. Patients presenting with retention, incomplete emptying or storage, or voiding symptoms suggesting obstruction after pubovaginal sling placement were evaluated with videourodynamic studies and cystourethroscopy. The diagnosis of obstruction was made on the basis of a combination of clinical, urodynamic, and endoscopic findings. All patients underwent a midline incision of the sling by way of a transvaginal approach without formal urethrolysis. RESULTS: The mean patient age was 57 years. Fifteen women (79%) had an autologous rectus fascial sling, 3 (16%) an allographic fascia lata sling, and 1 (5%) a polypropylene sling. Twelve women (63%) presented with urinary retention and required catheterization to empty. The other 7 women presented with obstructive and/or irritative symptoms without the need to catheterize. The mean time to sling lysis was 10.6 months from the initial surgery. The mean follow-up was 12 months (range 1 to 55). Overall, sling lysis was successful in 84% of the women. Stress incontinence recurred in 17%. No significant perioperative complications occurred. CONCLUSIONS: Pubovaginal sling lysis without formal urethrolysis appears to be a safe and effective method of relieving obstruction. The success and recurrent stress incontinence rates are comparable to those with formal urethrolysis.

Female↗
PubMed2002

Pubovaginal sling and pelvic prolapse repair in women with occult stress urinary incontinence: effect on postoperative emptying and voiding symptoms.

OBJECTIVES: To determine the perioperative morbidity of performing a concurrent pubovaginal sling with prolapse repair in women with occult (or potential) stress incontinence, particularly on voiding dysfunction and emptying. METHODS: We reviewed the charts of 38 women with grade 3-4 pelvic prolapse and occult stress incontinence. All patients underwent video urodynamic testing with the prolapse unreduced and again with the prolapse reduced with a pessary or packing. The abdominal leak point pressure was determined. Appropriate surgical repair of all components of the prolapse was performed concurrently with pubovaginal sling placement. The outcomes were measured with respect to the time to spontaneous voiding, permanent urinary retention, development of stress incontinence or de novo urge incontinence, resolution of urge incontinence, and perioperative complications. RESULTS: The mean age was 72 years, and the mean follow-up was 15 months (range 6 to 39). The mean time required before spontaneous voiding resumed without the need for catheterization was 11.8 days (range 2 to 46). No patient developed permanent urinary retention. Two (9.5%) of 21 women without preoperative urge incontinence developed de novo urge incontinence. However, existing urge incontinence resolved in 45%. One woman developed a suprapubic wound infection, which resolved with conservative management. Stress incontinence occurred in 2 women (7%) at 4 and 19 months postoperatively. Clinically significant prolapse (uterine) developed in 1 patient 2 years after surgery. CONCLUSIONS: Simultaneous pubovaginal sling placement for women with occult stress incontinence undergoing repair of a large pelvic prolapse is effective in preventing postoperative stress incontinence and has little negative effect on postoperative bladder emptying. It should be considered in all women with occult stress incontinence undergoing prolapse repair.

Aged↗
PubMed2002

Overactive bladder in men: special considerations for evaluation and management.

Lower urinary tract symptoms (LUTS) in men may arise from a variety of underlying causes, including benign prostatic hyperplasia. LUTS may have a significant component of storage symptoms (urgency, frequency, urge incontinence) at presentation; however, the absence of overactive bladder (OAB) symptoms does not necessarily imply pure outlet obstruction nor does their presence indicate the lack thereof. Symptomatic correlates to urodynamic findings are high when considering isolated OAB symptoms. However, mixed presentations or more overtly obstructive scenarios have less correlation with baseline symptom appraisal instruments. The ideal approach for diagnosis and management is predicated on a graded approach, with more invasive evaluation withheld for those men in whom presumptive therapy fails or who present with associated complex symptoms and in whom a higher level of intervention is being considered. The increasing incidence of LUTS with age implies a partial detrusor contribution, which must be considered in the overall management schema.

Adult↗
PubMed2002

Future studies of overactive bladder: the need for standardization.

Clinicians and researchers agree that pharmacologic studies of the overactive bladder (OAB) require precise planning, strict adherence to study design, and meticulous attention to study conduct and statistical methods. In addition, there should be straightforward and highly directed formulation of the conclusions derived expressly from data that have been collected. The exact methods to achieve these ends, however, are often debated among statisticians and experts in study design and by physicians who interpret the clinical implications of the findings. For these reasons, the conclusions of clinical research in OAB are commonly criticized on the basis of study objectives, study design, statistical methods, or conclusions. However, a subtler, but possibly more critical problem exists: the method of defining the population and the methods for collecting the data for the efficacy outcome parameters, including frequency, urgency, and urge incontinence.

Adult↗