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2.
Urology ; 52(4): 625-30, 1998 Oct.
Article in English | MEDLINE | ID: mdl-9763082

ABSTRACT

OBJECTIVES: To investigate by urodynamic study position-related changes in uroflowmetry and postvoid residual urine volume (PVR) in men because altered bladder function in the supine position may be a predisposing factor for urinary tract infections in the institutionalized elderly. METHODS: Two healthy men, 34 and 59 years of age and living at home, and 53 nursing home residents (mean age 71.8 years, range 46 to 92) were evaluated with uroflowmetry in the standing and recumbent positions (lying on the left or right side); corresponding PVRs were measured by transabdominal ultrasonic bladder scanning. The two healthy men were monitored longitudinally with multiple recordings in both voiding positions, and the nursing home residents were subjected to two observations: one measurement of the variable parameters in either position. Differences were considered to be significant at P < 0.05. RESULTS: The 34-year-old man performed 51 3 flows (368 standing and 145 recumbent). The mean of all the peak flow rates in the upright (28.2 +/- 4.2 mL/s) versus the recumbent (16.8 +/- 4.1 mL/s) position revealed a highly significant difference (P = 0.0001). Sixteen urinary flows and corresponding PVRs were completed by this subject in either voiding position. The difference between PVRs in the standing (13.1 +/- 14.7 mL) versus recumbent (15.3 +/- 17.5 mL) position was not statistically significant. The 59-year-old man completed 156 flows (128 standing and 28 recumbent). A highly significant difference was noted between the mean of all peak flows in the upright (18.9 +/- 4.1 mL/s) versus recumbent (12.6 +/- 2.0 mL/s) position (P = 0.0001). Thirty-seven urinary flows and corresponding PVRs were completed by this individual (10 PVRs were determined after voiding in the standing and 27 after voiding in the recumbent position). No significant difference was noted between PVRs in the standing (24.6 +/- 34.4 mL) versus recumbent (16.5 +/- 60.0 mL) position. In the nursing home residents, the difference between the mean peak flow rates in the standing (14.5 +/- 8.6 mL/s) versus recumbent (12.4 +/- 6.7 mL/s) position also reached statistical significance (P = 0.0084). The difference between PVRs in the standing (60.5 +/- 125.6 mL) versus recumbent (84.8 +/- 186.2 mL) position barely reached statistical significance (P = 0.0497). CONCLUSIONS: The urinary flow rate decreases in the recumbent position. Bedridden residents may be predisposed to urinary tract infections because of alterations in voiding dynamics in the supine position. This area needs further study.


Subject(s)
Posture , Urination/physiology , Urodynamics , Adult , Aged , Aged, 80 and over , Humans , Longitudinal Studies , Male , Middle Aged
3.
Prostate ; 34(3): 182-90, 1998 Feb 15.
Article in English | MEDLINE | ID: mdl-9492846

ABSTRACT

BACKGROUND: Involuntary detrusor contractions often cause irritative symptoms such as urgency and incontinence. A dog model for acutely induced variable bladder outlet resistance was developed to investigate the possible role of prostatic afferent nerve fibers in the development and maintenance of detrusor instability. METHODS: Fifty-eight mongrel dogs (weight range 19.5-36.5 kg) were divided into five groups: group I (n = 11) had surgically induced bladder outlet obstruction. Group II (n = 14) had urinary obstruction and bilateral sectioning of the lowest branches of the pelvic plexus supplying the prostate. Group III (n = 10) had prostate denervation only. Groups IV (n = 10) and V (n = 13) were sham-operated and controls, respectively. In the obstructed groups (I and II), an artificial urinary sphincter (length 4.5-6.0 cm) was placed around the bladder neck and connected to a reservoir placed subcutaneously to allow postoperative adjustments of urinary resistance. All dogs were evaluated at baseline and postoperatively at 1, 3, and 6 months with uroflowmetry, postvoid residual urine volume, cystometry as well as serum creatinine, and urinalysis. RESULTS: Occurrences of detrusor instability were not associated with prostatic denervation input. The mean peak flow rates decreased significantly in the obstructed groups at all follow-ups, but did not change significantly in the nonobstructed groups. Postoperatively, the mean maximum bladder capacity was significantly decreased for groups I and II only. However, a significant correlation between maximum bladder capacity and maximum detrusor pressure could not be detected at any time point in any of the groups. Mean postvoid residual urine volume varied considerably in all groups over time. Creation of a urinary model of infravesical obstruction was associated with considerable problems. CONCLUSIONS: In our dog model of bladder outlet obstruction, prostatic sensory nerve fibers appear not to be involved in detrusor instability. Surgical induction of a constant model of bladder outlet obstruction was difficult even in a large animal. The observations from the present study raise questions about the validity of obstructive urinary animal models.


Subject(s)
Muscle, Smooth/physiopathology , Neurons, Afferent/physiology , Prostate/innervation , Urinary Bladder Neck Obstruction/complications , Urination Disorders/etiology , Animals , Disease Models, Animal , Dogs , Follow-Up Studies , Hypogastric Plexus/surgery , Male , Muscle Contraction , Severity of Illness Index , Urinary Bladder Neck Obstruction/physiopathology , Urination Disorders/physiopathology , Urodynamics
4.
Br J Urol ; 81(1): 36-41, 1998 Jan.
Article in English | MEDLINE | ID: mdl-9467474

ABSTRACT

OBJECTIVE: To compare the Danish Prostatic Symptom Score (DAN-PSS) with the International Prostatic Symptom Score (IPSS). Madsen-Iversen and Boyarsky symptom indexes in a clinical setting, and to evaluate the potential significance of any differences in information obtained from these questionnaires. PATIENTS AND METHODS: The study comprised two substudies: in the first, 205 patients with lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction (BOO), a Madsen-Iversen score > 6 and a maximum flow rate of < 10 mL/s were randomized to receive either placebo or alfuzosin in a double-blind study of 16 weeks. The symptoms were assessed using the Madsen-Iversen, DAN-PSS and the IPSS questionnaires. In the second, 138 patients with LUTS suggestive of BOO were selected for treatment with transurethral microwave thermotherapy (TUMT, 52 degrees C for 60 min, microwave energy 200 kJ) and their symptoms assessed using the Boyarsky and the DAN-PSS questionnaires. Patients were then followed for one year. Rank correlation coefficients and regression lines were calculated using Spearman's non-parametric test. The relative changes, i.e. responsiveness, calculated for the DAN-PSS, IPSS and Boyarsky indexes were compared pairwise using the Wilcoxon-Pratt test. RESULTS: The DAN-PSS, IPSS and Madsen-Iversen indexes were correlated on a pairwise basis. The DAN-PSS and IPSS indexes have significant construct validity in terms of correlation with the Madsen-Iversen system (Spearman's correlation coefficient, rs = 0.51 and rs = 0.45, respectively). The DAN-PSS and the IPSS indexes were correlated (rs = 0.61). The DAN-PSS was more sensitive than the IPSS to changes after pharmacological treatment, with scores decreasing 70% and 29% (P < 0.05), respectively, after treatment with an alpha-blocker for 4 months, and 50% and 29% (P < 0.05), respectively, after 4 months on placebo treatment. Finally, the responsiveness of the Boyarsky and DAN-PSS indexes to TUMT showed that the DAN-PSS system was significantly more responsive than the Boyarsky index, with scores decreasing 57% and 15% (P < 0.05), respectively, after one year. CONCLUSIONS: The DAN-PSS index is more sensitive than the IPSS, Madsen-Iversen and Boyarsky symptom indexes, incorporates important outcome events, includes a patient-weighting of each symptom, thereby reflecting better the patients' global assessment of outcome.


Subject(s)
Adrenergic alpha-Antagonists/therapeutic use , Hyperthermia, Induced/methods , Prostatic Hyperplasia/therapy , Quinazolines/therapeutic use , Double-Blind Method , Humans , Male , Microwaves/therapeutic use , Prostatic Hyperplasia/complications , Quality of Life , Severity of Illness Index , Single-Blind Method , Surveys and Questionnaires , Treatment Outcome , Urination Disorders/etiology , Urination Disorders/therapy
5.
Urology ; 50(1): 142-9, 1997 Jul.
Article in English | MEDLINE | ID: mdl-9218039

ABSTRACT

OBJECTIVES: To evaluate three popular storage media and the effect of 24-hour cold storage on bladder tissue. METHODS: Guinea pig bladders were stored in three solutions: UW solution (a media used for transplant organs), Reznikoff solution [cell culture medium], and Krebs' solution with and without aeration. RESULTS: Cell potassium and sodium concentrations and total tissue water (a measurement of cell swelling) are important parameters for evaluating tissue damage. Reznikoff solution and Krebs' solution without gases maintained tissues for 24 hours with the least tissue damage; these solutions require no special equipment or attention. Twenty-four hour uniterrupted aeration of Krebs' solution caused the greatest degree of cell swelling with possible redistribution of receptors and required adjustment and regulation of the preservation apparatus. UW solution induced dehydration of cells, required the longest recovery period after cold storage, and is far more expensive than the other solutions. CONCLUSIONS: Reznikoff solution caused consistent relative changes in smooth muscle receptors and was superior to aerated Krebs' and UW solutions for 24-hour bladder tissue storage. It is unnecessary to aerate Krebs' solution during 24-hour cold storage.


Subject(s)
Organ Preservation Solutions , Tissue Preservation , Urinary Bladder/cytology , Adenosine , Allopurinol , Animals , Cold Temperature , Glutathione , Guinea Pigs , In Vitro Techniques , Insulin , Isotonic Solutions , Muscle Contraction , Muscle, Smooth/physiology , Raffinose , Time Factors
7.
Ugeskr Laeger ; 158(20): 2853-8, 1996 May 13.
Article in Danish | MEDLINE | ID: mdl-8686021

ABSTRACT

Benign prostatic hyperplasia (BPH) is the most common cause of voiding dysfunction in elderly men. With the age related demographic changes in the western world, the epidemiological and economical burden of BPH is anticipated to increase. BPH is clinically diagnosed on a variety of more or less well defined symptomatic, macroscopical, and physiological criteria, whereas the histological diagnosis is straightforward. Yet, no symptom is specific for BPH and numerous other diseases have to be considered when a patient presents with symptoms of bladder outlet obstruction. A BPH questionnaire is useful when weighing the pros and cons for intervention. Furthermore, a symptom index represents a valuable indicator for the quality of care provided. Through the last decades a number of BPH questionnaires have been introduced. This article scrutinizes various BPH indices and provides an introduction to the prerequisites of clinical questionnaires.


Subject(s)
Prostatic Hyperplasia/diagnosis , Aged , Humans , Male , Middle Aged
8.
Urology ; 45(5): 768-75, 1995 May.
Article in English | MEDLINE | ID: mdl-7538238

ABSTRACT

OBJECTIVES: To evaluate longer term effects of transurethral resection (TURP) and incision (TUIP) of the prostate in randomized patients. METHODS: In a randomized, prospective study, 120 patients with symptoms of bladder outlet obstruction caused by smaller benign prostates (estimated resectable weight less than 20 g) were assigned to TURP or TUIP. Patients were evaluated preoperatively and at intervals postoperatively as to urinary symptoms (Madsen's questionnaire), sexual function, and uroflowmetry. Overall evaluation of outcome of surgery was also assessed at follow-up visits. RESULTS: Fifty-six patients received a TURP and 61 a TUIP. Three patients refused to participate in the project after randomization, and 5 patients were lost to or excluded from follow-up. A group of 112 patients were obtainable for postoperative evaluation with a mean follow-up time of 34 months (1 to 82 months). Improvements in mean urinary peak flow rates were seen in both groups throughout the study period. The peak flow rates generally were higher (but not statistically so) in the TURP group. Postoperative irritative, obstructive, as well as total symptom scores decreased significantly at all follow-up visits after both TURP and TUIP (P < or = 0.034). Preoperatively and at all postoperative follow-up there was no statistically significant difference in irritative, obstructive, or total symptom scores between TURP and TUIP. The patients indicated an overall subjective improvement at all follow-ups in both groups, with no statistically significant difference between the treatment groups. Fifteen of 22 (68%) patients receiving TURP and 8 of 23 (35%) in the TUIP group who were sexually active before and after surgery developed postoperative retrograde ejaculation (P = 0.020). Postoperatively, 9 (16%) of the patients in the TURP and 14 (23%) in the TUIP group received further treatment for benign prostatic hyperplasia (BPH)-related infravesical obstruction. This difference was not statistically significant (P = 0.908). CONCLUSIONS: In small prostates TURP and TUIP were generally equally effective in relieving bladder outlet obstruction secondary to BPH. Most surgically treated BPH cases can be well managed by the incision technique, which is an underutilized procedure.


Subject(s)
Prostatectomy/methods , Prostatic Hyperplasia/surgery , Urinary Bladder Neck Obstruction/surgery , Adult , Aged , Blood Loss, Surgical , Drainage , Follow-Up Studies , Humans , Intraoperative Period , Length of Stay , Male , Middle Aged , Pilot Projects , Postoperative Care , Preoperative Care , Prognosis , Prospective Studies , Prostatectomy/mortality , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/physiopathology , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/therapy , Reoperation , Sexual Behavior , Survival Rate , Time Factors , Urinary Bladder Neck Obstruction/etiology , Urinary Bladder Neck Obstruction/physiopathology , Urodynamics
9.
Urologe A ; 34(2): 153-7, 1995 Mar.
Article in German | MEDLINE | ID: mdl-7538712

ABSTRACT

TUIP (transurethral incision of the prostate) or TURP (transurethral resection of the prostate) was performed in 120 patients to treat small-volume (< 20 g) benign prostatic hyperplasia in a prospective randomized study. The mean follow up was 43 months. Preoperatively and at regular follow-up visits obstructive and irritative symptom scores were obtained, sexual function was evaluated, and a uroflow study was performed. Both treatments achieved a marked improvement of symptoms. The obstructive, irritative and the total symptom scores did not differ significantly between TURP and TUIP. After 2-3 years the scores slowly increased in both groups. Subjective satisfaction rates averaged about 60% after more than 3 years and remained at this level. Initial significant differences in the peak flow rate in favour of TURP were no longer seen after more than 2 years. In smaller prostates TURP and TUIP are equally effective and since TUIP has fewer side effects and entails lower costs it appears to be an acceptable alternative to TURP.


Subject(s)
Prostatectomy/instrumentation , Prostatic Hyperplasia/surgery , Urinary Bladder Neck Obstruction/surgery , Adult , Aged , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/surgery , Prospective Studies , Recurrence , Reoperation , Urodynamics/physiology
10.
Scand J Urol Nephrol Suppl ; 172: 81-94, 1995.
Article in English | MEDLINE | ID: mdl-8578261

ABSTRACT

Benign prostatic hyperplasia (BPH) is a common disorder which places a considerable burden on older men and health care expenses. With advances in medical technologies and the foreseeable demographic changes in the Western world, the financial and epidemiological impact of this chronic disease is expected to increase further. The management of BPH is controversial, and this article critically reviews the clinical applicability and validity of the various measures available for assessment. Few objective modalities are indicated in the routine evaluation of BPH. There is a poor correlation between objective and subjective indicators and both measures reveal a substantial variation over time. This fluctuation is mainly attributed to the natural history of the disease. The clinical value of combining objective and subjective parameters into an analytic process seems small. Disagreements about the clinical value of BPH assessment modalities have caused inconsistent practices and consequently provision of changeable health care quality. Patients seek urological counseling and relief because of burden of illness. Quality care is provided by clinicians being perceptive to patients' preferences. Provision of quality care does not inevitably generate increasing health service expenses.


Subject(s)
Prostatic Hyperplasia , Humans , Male , Prognosis , Prostatectomy , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/diagnosis , Prostatic Hyperplasia/physiopathology , Prostatic Hyperplasia/therapy , Urodynamics
11.
Endocrinol Metab Clin North Am ; 23(4): 795-807, 1994 Dec.
Article in English | MEDLINE | ID: mdl-7535688

ABSTRACT

Benign prostatic hyperplasia (BPH) is the most common cause of bladder outlet obstruction and voiding symptoms in elderly men. The pathogenesis is not fully determined but a combination of androgens and age are needed for development of BPH. Symptoms of BPH are divided into obstructive and irritative symptoms but large interpersonal variability is found and no specific BPH symptom exists. Treatment modalities include surgery (TURP, TUIP, open prostatectomy, laser ablation, balloon dilatation, hyperthermia and thermotherapy, and urethral stents) and medical therapy. TURP is the gold standard treatment and TUIP is a safe and effective alternative to TURP in patients with smaller prostates. Laser ablation, hyperthermia and thermotherapy, and urethral stents are at the present time under investigation. Balloon dilatation is FDA-approved but not often used because of low efficacy and poor long-term results. Medical treatment includes alpha-blocker or finasteride treatment and is indicated in patients with moderate to severe symptoms of BPH without a strong indication for surgery.


Subject(s)
Prostatic Hyperplasia , Humans , Male , Prostate/pathology , Prostatic Hyperplasia/diagnosis , Prostatic Hyperplasia/etiology , Prostatic Hyperplasia/pathology , Prostatic Hyperplasia/therapy
12.
Urology ; 43(5): 617-20, 1994 May.
Article in English | MEDLINE | ID: mdl-7513105

ABSTRACT

OBJECTIVE: To identify risk factors for bacteriuria in a selected group of institutionalized men. METHODS: A total of 99 men, mean age seventy-one years, range forty-eight to one hundred four years, living in a nursing home were evaluated for diagnoses of benign prostatic hyperplasia (BPH) and diabetes mellitus (DM), symptoms of bladder outlet obstruction, and postvoid residual urine volume (PVR). At the time of evaluation urine cultures were performed for all subjects. Urinalyses had been performed in all men within the two years prior to initiation of the study. Residents unable to give informed consent, with a history of cancer of the prostate or bladder, previous urethral or prostate surgery, or inability to void in the standing position were excluded. RESULTS: Prior to or during the study 30 residents had bacteriuria, which was not correlated with age, PVR, previous diagnoses of BPH or DM, or with obstructive or irritative urinary symptoms consistent with bladder outlet obstruction. CONCLUSIONS: Competent, institutionalized residents with higher functional levels meeting the inclusion criteria were not at a high risk of bacteriuria. The concept that increased PVR per se predisposes to bacteriuria cannot be substantiated.


Subject(s)
Bacteriuria/epidemiology , Age Factors , Aged , Causality , Diabetes Mellitus/epidemiology , Homes for the Aged , Humans , Logistic Models , Male , Nursing Homes , Prostatic Hyperplasia/epidemiology , Risk Factors , Urinary Bladder Neck Obstruction/epidemiology , Urine
13.
Drugs ; 47(1): 66-81, 1994 Jan.
Article in English | MEDLINE | ID: mdl-7510622

ABSTRACT

During the past decades, pharmacological treatment of symptomatic benign prostatic hyperplasia (BPH) has become a fairly established modality. Approaches include blockade of alpha-adrenoreceptors and suppression of androgens. Patients eligible for drug treatment are those with mild to moderate symptoms of BPH and no strong indications for surgery. alpha-Receptor blockers generally improve urinary symptoms and peak urinary flow rates 2 to 4 weeks after introduction of therapy. Because of minor adverse effects, selective alpha 1-blockers are preferred over nonselective drugs. Prazosin, terazosin and alfuzosin are extensively studied and widely used in BPH treatment. Terazosin might be preferred to prazosin and alfuzosin because it can be administered once daily, but a disadvantage is higher cost. Doxazosin and tamsulosin (amsulosin; YM 617) are drugs currently under clinical investigation in the treatment of BPH. Antiandrogen therapy induces reduction in prostate volume and relief in symptoms of bladder outlet obstruction. However, the only drug which seems to be of major interest in BPH treatment is finasteride. Other drugs [gonadotrophin-releasing hormone (GnRH) agonists, progestogens and flutamide] are associated with frequent and sometimes severe adverse effects, such as impotence, flushing and loss of libido. Finasteride has fewer adverse effects and is well tolerated, but needs to be administered for at least 6 to 12 months to obtain maximum effect. Future approaches in medical treatment of BPH might be combination therapy of alpha 1-blockers and finasteride.


Subject(s)
Adrenergic alpha-Antagonists/therapeutic use , Androgen Antagonists/therapeutic use , Prostatic Hyperplasia/drug therapy , Humans , Male
14.
Helv Chir Acta ; 60(3): 345-9, 1993 Dec.
Article in German | MEDLINE | ID: mdl-8119812

ABSTRACT

The penile prosthesis AMS Hydroflex was successfully introduced in 1985, yet only 5 years later was withdrawn from the market. The approval process of medical devices in the USA and Switzerland is critically analyzed. While the American Food and Drug Administration (FDA) is responsible for approving the marketing of medical devices in the USA no such office exists in Switzerland. In Switzerland the physician takes full responsibility when using a device. It is, however, intended to introduce similar to the USA three regulatory control categories depending upon the degree of regulation necessary to assure safety and effectiveness of each device.


Subject(s)
Penile Prosthesis , United States Food and Drug Administration/legislation & jurisprudence , Adult , Aged , Aged, 80 and over , Equipment Safety , Humans , Male , Middle Aged , Retrospective Studies , Switzerland , United States
15.
Urology ; 42(4): 390-7, 1993 Oct.
Article in English | MEDLINE | ID: mdl-7692659

ABSTRACT

This retrospective study analyzes variation in prostate-specific antigen (PSA) levels in 129 males who were not diagnosed with prostate cancer or other known malignancies. The extent to which the assay and the biologic variation contributed to the variation in PSA concentration was evaluated from analysis of slopes characterizing PSA concentration as a function of time. The mean coefficient of variation on observations was 58.0 percent. The estimated mean biologic coefficient of variation was 55.3 percent versus a mean assay coefficient of variation of 13.2 percent, indicating that the assay variation contributed negligibly to variation compared with the biologic variation. The concept that a PSA level which rises more than that attributable to assay variation indicates the need for invasive testing for prostate cancer is questionable. A decreasing PSA level was seen as often and of the same magnitude as an increasing level within a relatively narrow window of approximately one year. We are aware of no reason why this variability in PSA values would not be observed in patients with occult prostate cancer.


Subject(s)
Prostate-Specific Antigen/blood , Aged , Aged, 80 and over , Analysis of Variance , Humans , Least-Squares Analysis , Linear Models , Male , Middle Aged , Retrospective Studies , Sensitivity and Specificity
16.
J Urol ; 150(2 Pt 1): 337-9, 1993 Aug.
Article in English | MEDLINE | ID: mdl-8326557

ABSTRACT

Postoperative urethral strictures following extracorporeal circulation in open heart surgery are not uncommon. The etiology is not clear. Ischemia and pressure of the Foley catheter may cause a lesion that eventually leads to urethral stricture. We retrospectively analyzed 300 patients who had undergone open heart surgery. In 1 group the bladder was drained by a Foley catheter during extracorporeal circulation, while another group underwent suprapubic drainage. Strictures developed in 10 of 152 patients (6.6%) with an indwelling catheter. Conversely, no strictures occurred in the 148 patients treated with suprapubic urinary drainage. The use of suprapubic drainage during extracorporeal circulation greatly decreases the risk of postoperative urethral strictures.


Subject(s)
Extracorporeal Circulation/adverse effects , Urethral Stricture/prevention & control , Urinary Catheterization , Adolescent , Adult , Aged , Aged, 80 and over , Cardiac Surgical Procedures , Child , Child, Preschool , Cystostomy , Humans , Male , Middle Aged , Retrospective Studies , Urethral Stricture/etiology , Urinary Catheterization/methods
17.
J Urol ; 149(5 Pt 2): 1304-7, 1993 May.
Article in English | MEDLINE | ID: mdl-8479021

ABSTRACT

The AMS Hydroflex* penile prosthesis was introduced for commercial distribution in 1985 but 5 years later this device was no longer available on the United States market. In an attempt to understand why this device, which initially enjoyed substantial popularity, was abruptly withdrawn from the market, patients who underwent implantation at the University of Wisconsin were interviewed and a critical analysis of the Food and Drug Administration approval process of medical devices was performed. An AMS Hydroflex penile prosthesis was implanted in 17 patients (mean age 57.7 years, range 27 to 84 years). The followup period ranged from 37 to 73 months with a mean of 58 months, and 3 patients died within that time. Of the remaining patients 10 (71%) were satisfied with the device in the first months after implantation but only 6 (43%) were satisfied at the time of followup, 9 (64%) were more satisfied with sexual relationships after receiving the prosthesis and 7 (50%) found the prosthesis simple to operate. Mechanical failure was noticed by 11 patients (79%), of whom 5 (45%) underwent further surgery. Classification of medical devices started with the enactment of the Medical Device Amendment to the Federal Food, Drug and Cosmetic Act, May 28, 1976. All medical devices that were in commercial distribution at that time were classified in 3 regulatory control categories depending upon the degree of regulation necessary to assure safety and effectiveness of each device. Before May 28, 1976 no approved application was necessary for marketing medical devices, and the Food and Drug Administration has variable amounts of information about safety and effectiveness of the different devices marketed prior to that date. Since May 1976 approved applications have been mandated for new or significantly changed devices. The specific process by which the Hydroflex prosthesis, as well as other medical devices, is approved is critically reviewed.


Subject(s)
Erectile Dysfunction/surgery , Penile Prosthesis , Adult , Aged , Aged, 80 and over , Follow-Up Studies , Humans , Male , Middle Aged , Prosthesis Design , Prosthesis Failure , Reoperation , Urology/instrumentation
20.
J Androl ; 12(6): 415-22, 1991.
Article in English | MEDLINE | ID: mdl-1722798

ABSTRACT

Transurethral incision of the prostate (TUIP) is compared to transurethral resection of the prostate (TURP) by reviewing nonrandomized, matched, and randomized studies. These studies indicate that incision of the prostate and bladder neck relieves outflow urinary obstruction, as does TURP. The incision is relatively easier to learn and perform, and requires shorter operative time compared to TURP. The incidence of retrograde ejaculation is lower after incision than after TURP--16% versus 63%, on average. Transurethral incision of the prostate has a potential for reduced costs due to reduced operative time, shortened hospital stay, and the potential for local anesthesia.


Subject(s)
Prostatectomy/methods , Urinary Bladder/surgery , Humans , Male , Prostatic Hyperplasia/surgery
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