Niall T.M. Galloway

Extracorporeal magnetic innervation therapy for stress urinary incontinence.

OBJECTIVES To report the first data from a prospective clinical study to determine the feasibility of using extracorporeal magnetic innervation (ExMI) for the treatment of stress urinary incontinence. METHODS We studied 83 women with demonstrable stress urinary incontinence. Treatments were for 20 minutes, twice a week for 6 weeks. For treatment, the patient sits fully clothed on a special chair; within the seat is a magnetic field generator that produces the rapidly changing magnetic field flux. Objective measures included bladder diaries, dynamic pad weight testing, urodynamic studies, and quality of life survey. RESULTS Fifty patients have been followed up for longer than 3 months (33 patients for less than 3 months); 17 patients (34%) were dry, 16 (32%) were using not more than 1 pad per day, and 17 (34%) were using more than 1 pad per day. Pad use was reduced from 2.5 to 1.3 (P = 0.001) and leak episodes per day were reduced from 3.3 to 1.7 (P = 0.001). The pad weight was reduced from 20 to 15 g. Detrusor instability was found in 5 patients before but was demonstrated in only 1 patient after treatment. CONCLUSIONS ExMI therapy offers a new effective modality for pelvic floor muscle stimulation. ExMI is painless, there is no need for a probe, and no need to undress for treatments. Longer follow-up is required to determine how long the benefits of treatment last and whether retreatment will be necessary.

Impaired Bladder Perfusion in Interstitial Cystitis: A Study of Blood Supply Using Laser Doppler Flowmetry

Laser doppler flowmetry was used to study bladder blood flow in 16 patients with interstitial cystitis and in 18 control subjects. All studies were performed at cystoscopy under general anesthesia. Interstitial cystitis patients conformed to the diagnostic criteria of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Blood flow measurements were made at four specific sites in the bladder at a capacity of 100 ml. and at full capacity. The mean maximum capacity under anesthesia was 828 cc for the control group and 562 cc for the IC group. Blood flow at low capacity was similar in the two groups. When the bladder was filled to capacity, blood flow increased by a mean of 9.05 LDF units in the control group but only by 0.06 LDF units in the IC group (p = 0.007). Vault perfusion increased considerably more in the control group compared to the IC group (p = 0.002). The mean ratio of vault to trigonal perfusion was similar in both groups and was not affected by the overall blood flow changes which accompanied distension. Although the mean bladder capacity under anesthesia was greater in the control group, covariant analysis showed that the significant differences in perfusion between the two groups occurred independently of changes in capacity. It is concluded that bladder perfusion at capacity is significantly impaired in interstitial cystitis.

An Objective Score to Predict Upper Tract Deterioration in Myelodysplasia

Bladder dysfunction in myelodysplasia may present a significant hazard to the upper tract and a threat to kidney function. Urodynamic features of high leak pressure and detrusor-sphincter dyssynergia have been associated with an increased risk. We have developed an objective score to describe urodynamic findings in myelodysplasia. The score includes consideration of bladder compliance, detrusor contractility and reflux, in addition to leak pressure and sphincter behavior. In 171 myelodysplastic patients a significant correlation was demonstrated between the score and upper tract studies at the time of urodynamics and the score and the management decision. Of 73 myelodysplasia patients with normal upper tracts at the first urodynamics study hydronephrosis later developed in 14. The score was a potent predictor of outcome (p = 0.0006).

Paravaginal defect repair in the treatment of female stress urinary incontinence and cystocele

OBJECTIVES To assess the functional and anatomic results of the paravaginal defect repair (PVdR) in women with stress urinary incontinence (SUI) due to bladder neck hypermobility (BNH) and cystocele. METHODS Fifty-two consecutive patients with a mean age of 61 years underwent PVdR for the treatment of SUI associated with BNH and varying degrees of vaginal prolapse. Twenty-five patients underwent PVdR alone (group 1), and 27 underwent PVdR in association with a rectus muscle sling (group 2) for the treatment of intrinsic sphincter deficiency. All patients had SUI and lateral defect cystocele (paravaginal defect). Associated vaginal and pelvic floor defects included rectocele in 34, vault prolapse in 24, and enterocele in 18; these defects were repaired simultaneously and had an equal distribution among the two groups. RESULTS At a mean follow-up of 17 months, the cure rate (defined as no pads and no leakage) was 79% (group 1, 72%; group 2, 85%). When expanded to include substantially improved (1 pad/day or less), the success rate was 88% (group 1, 84%; group 2, 93%). Recurrent vaginal prolapse occurred in 8 patients, 6 of whom had PVdR alone. For those patients with failure, time to recurrence of incontinence was 15 and 23 months in groups 1 and 2, respectively. CONCLUSIONS PVdR restores the normal lateral attachment of the pubocervical fascia to the arcus tendineous fascia pelvis of the pelvic sidewall and provides anatomic repair of lateral defect cystoceles. In women with anatomic SUI, PVdR restores continence by alleviating BNH and should be used in conjunction with a sling procedure in those with intrinsic sphincter deficiency.

Update on extracorporeal magnetic innervation (ExMI) therapy for stress urinary incontinence

Pulsed magnetic technology has been developed for pelvic floor muscle strengthening for the treatment of urinary incontinence. This report includes an update of the prospective multicenter study of extracorporeal magnetic innervation (ExMI) therapy for stress incontinence and a discussion of the possible mechanisms of action. Issues of patient selection for ExMI therapy will also be discussed. One hundred and eleven women with demonstrable stress urinary incontinence were studied. The mean age was 55 +/- 13 years, and the mean duration of symptoms was 11 years. Ninety-seven completed ExMI therapy and analysis. Evaluation before treatment included bladder diaries, dynamic pad weight test, urodynamics, and a quality-of-life survey. For treatment the patients were seated fully clothed in a Neocontrol chair with a magnetic field therapy head in the seat. Treatment sessions were for 20 minutes, twice a week, for 6 weeks. After ExMI therapy, all of the measures were repeated at 8 weeks, including the dynamic pad weight testing and quality-of-life survey. At 6 months, further data were added, including repeat bladder diary, pad use, and quality-of-life survey. Forty-seven women completed 6 months of follow-up; of the 47, 13 patients were completely dry (28%) and 25 used no pad or less than 1 pad per day (53%). Pad use was reduced in 33 patients (70%). The median number of pads was reduced from 2.16 to 1 per day (Wilcoxon signed rank test, P <0.005). The frequency of leak episodes was reduced from 3.0 to 1.7 at 6 months (Wilcoxon signed rank test, P = 0.004). Detrusor instability was demonstrated in 10 before and 6 after ExMI (P <0.05). ExMI offers an alternative approach for the treatment of urinary incontinence. ExMI therapy is effective for both stress and urge incontinence. The best results are achieved in those patients who use no more than 3 pads a day and have had no prior continence surgery.

USE OF RECTUS ABDOMINIS MUSCLE FLAP FOR THE TREATMENT OF COMPLEX AND REFRACTORY URETHROVAGINAL FISTULAS

PURPOSE Urethrovaginal fistulas are commonly repaired transvaginally with local tissue flaps, such as the Martius labial fat pad graft. Although this flap is ideal, if it fails and the fistula persists, subsequent treatment options are limited. We describe the use of a pedicled rectus abdominis muscle flap for the repair of complex and refractory urethrovaginal fistulas. MATERIALS AND METHODS Six women with a mean age of 53 years (range 41 to 62) who had complex and refractory urethrovaginal fistulas were referred to our continence center. Mean number of prior attempted repairs was 1.3 and in all cases at least 1 Martius flap had failed. Transvaginal urethrovaginal fistula closure was performed followed by a pedicled rectus abdominis muscle flap interposed between the fistula closure and vaginal suture line. The muscle flap was based on the inferior epigastric vessels, and provided additional support to the urethra, bladder neck and bladder base. RESULTS Urethrovaginal fistula repair with the rectus abdominis muscle flap was successful in all cases. No fistula recurred. Of the patients 5 (83%) were continent and able to void to completion at a mean followup of 23 months (range 2 to 66). CONCLUSIONS The rectus abdominis muscle flap is a useful adjunct in the repair of complex and refractory urethrovaginal fistulas. It can be used with confidence to provide support to the bladder neck and proximal urethra in patients after failed prior repair with the Martius flap procedure. The pelvic surgeon may be able to recognize other applications for the rectus abdominis muscle flap in pelvic floor reconstruction.

Normal range prostate-specific antigen versus age-specific prostate-specific antigen in screening prostate adenocarcinoma

OBJECTIVES Prostate-specific antigen (PSA) has become the most useful serum tumor marker in the diagnosis and screening of prostate adenocarcinoma. The currently cited reference range of normal (0 to 4.0 ng/mL monoclonal) lacks both the sensitivity and specificity to be universally accepted as a screening test, and alternatives to serum PSA have been proposed, such as PSA density, PSA velocity, and age-adjusted PSA. Age-adjusted PSA takes into account the facts that as men grow older the prostate enlarges and that screening should have maximum sensitivity in younger men and maximum specificity in older men. METHODS A population of 4,710 men with no known history of prostate adenocarcinoma underwent 5,629 examinations by transrectal ultrasound of the prostate (TRUS) from 1987 to 1994. This population consists of Mobile Urology Group, Mobile, Alabama, and Emory University, Atlanta, Georgia, patient databases. We have examined our data to determine the sensitivity, specificity, and positive predictive values for normal range PSA (0 to 4 ng/mL) versus age-specific PSA values. RESULTS A total of 2040 patients had an abnormal digital rectal examination (DRE) and 3581 procedures were performed for an elevated PSA and a normal DRE. Biopsies were performed in 2,657 patients with 945 (35.6%) positive for cancer. Criteria for biopsy included elevated PSA (more than 4 mg/mL), PSA density more than 0.15 abnormal DRE, or suspicious TRUS. Patients were grouped according to decade: group 1 (ages 40 to 49 years, n = 183), group 2 (ages 50 to 59 years, n = 1018), group 3 (ages 60 to 69 years, n = 2358), and group 4 (ages 70 to 79 years, n = 1687). CONCLUSIONS Use of the age-specific range for PSA increases the sensitivity in younger men more likely to benefit from treatment, and decreases the biopsy rate in older patients who may not be candidates for aggressive treatment. Age-adjusted PSA is the most valuable for patients over the age of 70 years of whom 22% would be spared TRUS with biopsy.

Surgical Treatment of Interstitial Cystitis: Indications, Techniques, and Results

Conservative treatment should be satisfactory for 90 per cent of patients with interstitial cystitis. When severe symptoms are refractory and constitute a major disability, surgical treatment should be considered. Usually symptoms will have been present for at least three years before operative methods are used. If bladder capacity (general anesthetic) is greater than 400 ml, and the major symptom is bladder pain, denervation by cystolysis may be considered. If bladder capacity (general anesthetic) is less than 400 ml, supratrigonal cystectomy and substitution colocystoplasty is the treatment of choice.

The Adjustable Continence Therapy System for Recurrent Female Stress Urinary Incontinence: 1-Year Results of the North America Clinical Study Group

PURPOSE We determined the efficacy, safety, adjustability and technical feasibility of the adjustable continence therapy device (Uromedica, Plymouth, Minnesota) for the treatment of recurrent female stress urinary incontinence. MATERIALS AND METHODS Female patients with recurrent stress urinary incontinence were enrolled in the study and a defined set of exclusionary criteria were followed. Baseline and regular followup tests to determine eligibility, and to measure subjective and objective improvement were performed. A trocar was passed fluoroscopically and with digital vaginal guidance to the urethrovesical junction through small incisions between the labia majora and minora. The adjustable continence therapy device was delivered and the balloons were filled with isotonic contrast. The injection ports for balloon inflation were placed in a subcutaneous pocket in each labia majora. Device adjustments were performed percutaneously in the clinic postoperatively. An approved investigational device exemption Food and Drug Administration protocol was followed to record all adverse events. RESULTS A total of 162 subjects underwent implantation with 1 year of data available on 140. Mean Stamey score improved by 1 grade or more in 76.4% (107 of 140) of subjects. Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p <0.001). Reductions in mean Urogenital Distress Inventory (60.3 to 33.4) and Incontinence Impact Questionnaire (54.4 to 23.4) scores also occurred (p <0.001). Mean provocative pad weight decreased from 49.6 to 11.2 gm (p <0.001). Of the patients 52% (67 of 130) were dry at 1 year (less than 2 gm on provocative pad weight testing) and 80% (102 of 126) were improved (greater than 50% reduction on provocative pad weight testing). Complications occurred in 24.4% (38 of 156) of patients. Explantation was required in 18.3% (28 of 153) of the patients during 1 year. In terms of the complications 96.0% were considered to be mild or moderate. CONCLUSIONS The Uromedica adjustable continence therapy device is an effective, simple, safe and minimally invasive treatment for recurrent female stress urinary incontinence. It can be easily adjusted percutaneously to enhance efficacy and complications are usually easily manageable. Explantation does not preclude later repeat implantation.

The Gastric Augment Single Pedicle Tube Catheterizable Stoma: A Useful Adjunct to Reconstruction of the Urinary Tract

Since 1990 we have used stomach for bladder augmentation and continent urinary diversions in 73 patients, of whom 15 received a gastric tube catheterizable stoma and are the subject of this report. The gastric tube receives its blood supply from the same vascular pedicle as the gastric patch and, therefore, it can be moved anywhere along with the patch. The tube is then reimplanted in the reservoir or bladder following the Mitrofanoff principle and brought to the skin as a catheterizable stoma. Patient age ranged from 12 to 60 years. Three patients underwent augmentation cystoplasty and 12 received a composite gastrointestinal continent reservoir (in 10 a prior bowel conduit was detubularized and used as part of the reservoir). The appendix was either previously removed (10 patients) or not suitable as a catheterizable limb (4). All patients are continent. Catheters used to empty the reservoir varied from 12F to 18F. Complications included an early traumatic perforation of the tube in 1 patient, distal stenosis in 1 and mucosal redundancy in 1. Of these patients 2 required revision. Two patients had mild peristomal skin irritation without ulceration. Anatomical and technical aspects of this procedure are presented. In summary, we believe the gastric augment single pedicle tube to be a useful tool for the reconstructive urologist, which in select cases may obviate the need for additional bowel anastomosis to create a tapered intestinal catheterizable limb.