The effectiveness of surgery for stress incontinence in women: a systematic review

OBJECTIVE: To determine the methodological quality of studies evaluating surgery for stress incontinence, the effectiveness of different procedures and the frequency of complications associated with each procedure. MATERIALS AND METHODS: Eleven randomized controlled trials, 20 non-randomized trials/prospective cohort studies and 45 retrospective cohort studies were reviewed systematically. RESULTS: The methodological quality of the 31 prospective studies was generally poor. The considerable variation in inclusion criteria, surgical management and assessment of outcome precluded any statistical meta-analysis. Evidence as to the effectiveness of surgery for stress incontinence is weak; therefore, any conclusions are speculative. It appears that colposuspension may be more effective and the effect more long-lasting than that following anterior colporrhaphy and needle suspension. There is little information on the value of sling procedures. Comparisons of different ways of performing each procedure show no significant differences in outcome but this may reflect the methodological weaknesses of the studies. Valid and reliable data on the frequency of complications following surgery are lacking so the safety of the procedures is unclear. Repeat operations to correct stress incontinence are less successful than first procedures but this finding may be subject to confounding. CONCLUSIONS: There is an urgent need for some large, rigorous, prospective studies of high quality. Until such studies have been completed, recommendations as to the best clinical practice cannot be based on scientific evidence. Studies need to define cases according to widely accepted criteria, including standard measures of the severity of stress incontinence, and surgical terminology for the procedures performed needs to be standardized and outcomes need to be clearly defined, valid and reliable, not confined to short-term assessment and include patients' views along with the surgeon's assessments.     

Stamey-Lorenz operation for treatment of stress urinary incontinence in women

The Stamey-Lorenz operation was presented as a new method for treatment of stress urinary incontinence in women. During operation the urethra is suspended by using special needles and under cystoscopic control, thus proper vesico-urethral angle is restored. 10 incontinent women were cured using this method, 8 with good results. In two cases we failed.     

Treatment of stress urinary incontinence in women

Involuntary urinary leakage due to a rise in abdominal pressure caused by stress (cough, laugh, change in position, walking, running or carrying heavy weight) is a clinical entity often experienced by women. Management can be based on physical therapy techniques, drugs or surgery but indications and results to be expected are still very largely debated. Cure of an underlying condition such as obesity, or chronic bronchitis may be sufficient in some cases and others may benefit from "preventive" physical therapy to reinforce the perineum after difficult pregnancy and delivery. Alpha-stimulating drugs have also been proposed to increase sphincter tone. Surgery gives the best results. Several procedures have been proposed, usually based on classical retropubic colposuspension and aponevrosis loops. Success rate is approximately 80 to 90% although the lack of a sufficient understanding of the underlying mechanism involved, makes it impossible to predict outcome. Results in women with recurrent incontinence are less satisfactory.     

Yohimbine for erectile dysfunction: a systematic review and meta-analysis of randomized clinical trials

Well-founded pharmacokinetic information is one of the cornerstones of a New Drug Application (NDA) to the Food and Drug Administration (FDA) required to introduce a new drug or a generic equivalent (ANDA) to the marketplace. The service that laboratories engaged in therapeutic drug monitoring provide to support clinical activities is also needed by the pharmaceutical industry during the evaluation and introduction of drugs to the marketplace. In considering this alternative service activity, one must be aware of and compliant with rules established by the FDA for performance of such studies. As specified in CFR 21, Parts 58, 211, and 320, good clinical and laboratory practice indicates that the laboratory should employ a Lab Study Director, who is responsible for the validation of all procedures implemented to support a study protocol, ensures that the laboratory carries out the study following these defined procedures, and personally reviews the results of all testing. The laboratory must validate each procedure by demonstrating and documenting that the procedure does what it is designed to do while meeting the analytical performance specifications required by the study. Laboratory records of all activities must be maintained and available for inspection by the FDA on request. The FDA has authority over all activities related to NDA and ANDA submissions and can bring criminal charges if results of a study are changed because a laboratory deviates from standard procedure. Competent drug monitoring laboratories are fully capable of participating in clinical trials testing activities. Laboratory staff should be fully versed in the FDA rules governing these activities, validate all procedures, and establish systems to verify the procedures are carried out as specified.     

Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women

PURPOSE: A systematic review of randomized clinical trials (RCTs) was undertaken to assess the effectiveness of medical treatment for metastatic breast cancer. METHODS: RCTs published between 1975 and 1997 have been classified according to 12 therapeutic comparisons: (1) polychemotherapy (PCHT) agents versus single agent; (2) PCHT regimens with anthracycline versus PCHT without anthracycline; (3) other PCHT versus cyclophosphamide, methotrexate, and fluorouracil (CMF); (4) chemotherapy (CHT) with epirubicin versus CHT with doxorubicin; (5) CHT versus same CHT delivered with less intensive schedules; (6) other endocrine therapy (OET) versus tamoxifen; (7) OET plus tamoxifen versus tamoxifen alone; (8) OET versus medroxyprogesterone; (9) OET versus aromatase inhibitors; (10) OET versus megestrol; (11) endocrine therapy (ET) versus same ET at lower doses; and (12) CHT plus ET versus CHT. Tumor response rates, mortality hazards ratio (HR) and frequency of severe side effects were the outcome measures. RESULTS: A total of 189 eligible trials (31,510 patients) were identified. All provided response rates and 133 (70%) data or survival curves needed for calculation of the HR. In eight of 12 comparisons, statistically significant differences for response emerged (1, 2, 3, 5, 7, 8, 11, 12); all but no. 8 favored the first term of the comparison. Overall survival analysis showed better results of (a) PCHT versus single-agent CHT (HR=0.82; 95% confidence interval [CI], 0.75 to 0.90); (b) CHT with doxorubicin versus CHT with epirubicin (HR=1.13; 95% CI, 1.00 to 1.27); (c) CHT versus the same CHT delivered with less intensive schedules (HR=0.90; 95% CI, 0.83 to 0.97); (d) ET versus the same ET at lower doses (HR=0.86; 95% CI, 0.77 to 0.97). Quality of life was measured in only 2,995 of 31,510 patients (9.5%). CONCLUSION: Despite some evidence of effectiveness of specific regimens, the relevance of these findings is limited by the modest survival benefit and the lack of evaluation of the quality-of-life impact of these treatments.     

Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial

CONTEXT: Urinary incontinence is a common condition caused by many factors with several treatment options. OBJECTIVE: To compare the effectiveness of biofeedback-assisted behavioral treatment with drug treatment and a placebo control condition for the treatment of urge and mixed urinary incontinence in older community-dwelling women. DESIGN: Randomized placebo-controlled trial conducted from 1989 to 1995. SETTING: University-based outpatient geriatric medicine clinic. PATIENTS: A volunteer sample of 197 women aged 55 to 92 years with urge urinary incontinence or mixed incontinence with urge as the predominant pattern. Subjects had to have urodynamic evidence of bladder dysfunction, be ambulatory, and not have dementia. INTERVENTION: Subjects were randomized to 4 sessions (8 weeks) of biofeedback-assisted behavioral treatment, drug treatment (with oxybutynin chloride, possible range of doses, 2.5 mg daily to 5.0 mg 3 times daily), or a placebo control condition. MAIN OUTCOME MEASURES: Reduction in the frequency of incontinent episodes as determined by bladder diaries, and patients' perceptions of improvement and their comfort and satisfaction with treatment. RESULTS: For all 3 treatment groups, reduction of incontinence was most pronounced early in treatment and progressed more gradually thereafter. Behavioral treatment, which yielded a mean 80.7% reduction of incontinence episodes, was significantly more effective than drug treatment (mean 68.5% reduction; P=.04) and both were more effective than the placebo control condition (mean 39.4% reduction; P<.001 and P=.009, respectively). Patient-perceived improvement was greatest for behavioral treatment (74.1% "much better" vs 50.9% and 26.9% for drug treatment and placebo, respectively). Only 14.0% of patients receiving behavioral treatment wanted to change to another treatment vs 75.5% in each of the other groups. CONCLUSION: Behavioral treatment is a safe and effective conservative intervention that should be made more readily available to patients as a first-line treatment for urge and mixed incontinence.     

Antimicrobial prophylaxis in colorectal surgery: a systematic review of randomized controlled trials

BACKGROUND: A systematic review was carried out to assess the relative efficacy of antimicrobial prophylaxis for the prevention of postoperative wound infection in patients undergoing colorectal surgery. METHODS: MEDLINE, EMBASE, the Cochrane Trials Register and the references cited in retrieved studies were searched to identify relevant trials published between 1984 and 1995. RESULTS: Some 147 relevant trials were identified. The quality of trials has improved over the past 12 years. The results confirm that the use of antimicrobial prophylaxis is effective for the prevention of surgical wound infection after colorectal surgery. There was no significant difference in the rate of surgical wound infections between many different regimens. However, certain regimens appear to be inadequate (e.g. metronidazole alone, doxycycline alone, piperacillin alone, oral neomycin plus erythromycin on the day before operation). A single dose administered immediately before the operation (or short-term use) is as effective as long-term postoperative antimicrobial prophylaxis (odds ratio 1.17 (95 per cent confidence interval (c.i.) 0.90-1.53)). There is no convincing evidence to suggest that the new-generation cephalosporins are more effective than first-generation cephalosporins (odds ratio 1.07 (95 per cent c.i. 0.54-2.12)). CONCLUSION: Antibiotics selected for prophylaxis in colorectal surgery should be active against both aerobic and anaerobic bacteria. Administration should be timed to make sure that the tissue concentration of antibiotics around the wound area is sufficiently high when bacterial contamination occurs. Guidelines should be developed locally in order to achieve a more cost-effective use of antimicrobial prophylaxis in colorectal surgery.     

The pathophysiology of stress urinary incontinence in women and its implications for surgical treatment

OBJECTIVES: To estimate the total costs of multiple sclerosis (MS) for all Canadians in 1994. METHODS: Prevalence-based study estimating disease-related societal costs for Canadians with MS in 1994. The human capital approach was used to estimate the value of lost productivity due to illness. Two components were revealed: first, direct costs, in terms of expenditures on hospital care, other institutions, physician services, other health professionals, drugs, and other expenditures; and second, indirect costs, in terms of lost productivity due to premature mortality and disability. RESULTS: The total costs of MS for Canadians were $502.3 million in 1994, with direct and indirect cost components at $188.6 million and $313.7 million, respectively. CONCLUSIONS: This study highlights the scope and magnitude of the economic consequences of MS for Canadians. The costs calculated may be used to provide guidance in the setting of national priorities for research and prevention activities.     

Laparoscopic bladder-neck suspension for urinary stress incontinence in women: our first twenty patients

BACKGROUND: Laparoscopic bladder-neck suspension for women with urinary stress incontinence avoids the problems associated with a large abdominal incision. This study reviews the short-term outcome of this minimally invasive operation. METHODS: Between September 1993 and February 1995, 20 female patients with type II urinary stress incontinence underwent laparoscopic bladder-neck suspension at our institution (mean age, 46.6 years; mean weight, 59.5 kg; mean duration of symptoms, 3.75 years; mean follow-up, 7 months). The extraperitoneal space was created with a preperitoneal distention balloon system; dissection of the bladder and bladder neck was done via 3 working ports. In 16 patients, the paraurethral vagina on either side of the bladder neck was hitched up to the iliopectineal ligament by 2-0 sutures. In the remaining 4 patients, the bladder-neck suspension was performed using hernia mesh and staples. Four patients had intraperitoneal suspension. RESULTS: The operative time ranged from 75 to 205 minutes, with a mean of 111.5 minutes. The period of urethral catheterization ranged from 2 to 7 days, with a mean of 3.1 days. The hospitalization stay ranged from 5 to 15 days, with a mean of 6.35 days. Thirteen patients (65%) had complete resolution of symptoms, 5 patients (25%) reported significant improvement, and 2 patients (10%) did not benefit from the operation. CONCLUSION: Long-term follow-up is necessary to determine the efficacy of this laparoscopic technique. The success rate for any incontinence procedure is usually inversely proportional to the duration of follow-up.     

Bladder neck support prosthesis: a nonoperative treatment for stress or mixed urinary incontinence

PURPOSE: We evaluated the usefulness and safety of a bladder neck support prosthesis in patients with stress or mixed incontinence. MATERIALS AND METHODS: A total of 57 women with stress and 20 with mixed incontinence completed a 12-week prospective clinical trial of a bladder neck support prosthesis. While indexes of incontinence episodes, leakage amounts and urgency along with a bothersome index were subjectively evaluated, a 60-minute pad test and urinary flow parameters were objectively evaluated. Three patients scheduled to undergo surgery for stress incontinence voluntarily used the device, and provided urodynamic data and cystourethrograms. Two prongs at 1 end of the ring, a type of elastic vaginal pessary, elevate the bladder neck against the pubic bone and facilitate pressure transmission around the bladder neck, resulting in urinary continence. RESULTS: Four subjective indexes significantly improved. There was no urinary flow obstruction. Urine loss decreased from 20.6 to 4.8 gm. per hour (p < 0.001) on the 60-minute pad test. Of the patients 22 (29%) reported complete continence and 39 (51%) had decreased severity of incontinence by more than 50%. Minor adverse effects occurred in 26% of the patients. Taking subjective evaluation, changes in objective parameters and adverse effects into consideration, 62 patients (81%) had some or maximum benefit according to the global usefulness rating. CONCLUSIONS: The bladder neck support prosthesis is safe, well tolerated and clinically effective for the treatment of stress or mixed incontinence.     

Behavioral treatment of urinary incontinence: a complementary approach

When treating urinary incontinence, the first choice for treatment should be the least invasive and with the fewest side effects. Behavioral intervention is one such treatment modality. Behavioral interventions are defined as a change in the relationship between the patient's symptoms and his/her environment. Behavioral interventions include fluid and dietary management, toileting assistance, bladder retraining, urge suppression, and pelvic muscle rehabilitation. Intermittent self-catheterization is also considered a behavioral intervention when combined with fluid/dietary or toileting changes. Before selecting a treatment option, a detailed history, physical examination, and environmental assessment should be taken. In addition, to effectively employ behavioral interventions, the patient's goals should be determined, the patient should be taught about the underlying causes of his/her problem, and he/she should be provided with not only motivation, but also support. Finally, behavioral interventions recognize the significant contribution that the patient makes in his/her own recovery.     

Neuropsychological outcomes in randomized controlled trials of antiepileptic drugs: a systematic review of methodology and reporting standards

PURPOSE: To systematically review the methodology and use of neuropsychological tests in randomized controlled trials (RCTs) of antiepileptic drugs (AEDs) in patients with epilepsy. METHODS: Trial reports were found by searching Medline 1966-1996 and searching through journals by hand. Inclusion and exclusion criteria were applied, and methodological and neuropsychological test data was extracted by using a proforma. RESULTS: 43 reports met our inclusion criteria, representing 40 RCTs. as three RCTs had generated two reports. Twenty-two were actively controlled, and 18 were placebo-controlled studies. Reporting of basic methods such as randomization method was poor. There has been no uniform approach to the use of neuropsychological tests, and a total of 87 has been used. The Stroop Colour Word Test and the Finger Tapping Test were most commonly used, at 13 times each, but were not used or reported in a uniform manner. CONCLUSIONS: Poor reporting of methods and the use of a plethora of neuropsychological tests create great difficulties for anyone wishing to make sense of currently available data. If we are better to understand the neuropsychological effects of AEDs, a more rational approach is needed, for which recommendations are made.     

Pelvic floor rehabilitation in women affected with stress urinary incontinence. Authors' experience

BACKGROUND: This study evaluated pelvic floor rehabilitation as a possible treatment for urinary stress incontinence: a challenge to tradition. METHODS: In this study 20 female subjects with urinary stress incontinence had rehabilitation therapy, at first in the outpatients clinic with motivated physiotherapists and afterwards by home exercises. RESULTS: At the end of 3 months of training, stress incontinence had disappeared in 7 patients (35%), while an improvement was recorded in 13 (65%). CONCLUSIONS: In summary, pelvic floor rehabilitation program can be an effective alternative to surgical approach in reducing the frequency of urinary leakage. Further studies are needed to identify factors predicting success and to improve the techniques of pelvic floor rehabilitation.     

Non-surgical management of urinary stress incontinence

This article reviews the non-surgical approach to urinary stress incontinence. As the cost of medical care increases and the waiting lists for surgical operations grow bigger, non-surgical management of incontinence takes on importance. The cure rates or improvement of quality of life with conservative management of urinary stress incontinence are not as good as with the surgical approach but it is an option which may be used in selected patients. Whenever a patient or the health care provider embarks upon the non-surgical options, consideration should be given to the success rates of the modality, either used alone or in combination. The motivation and compliance of patient is important, individuals who have realistic expectations from non-surgical management of urinary stress incontinence usually have the best result.Recent literature was reviewed and an attempt has been made to present an objective assessment for all the modalities currently available for the incontinent woman. It is necessary to stress the need for the use of a combination of modalities for better results when non-surgical approach is used as the first line option. It is also important to be empathetic and supportive of such women as they usually have an extremely poor self esteem, are depressed and reclusive.     

Transrectal sonographic investigation of urethral and paraurethral structures in women with stress urinary incontinence

Transrectal sonography of the urethra was used in 14 asymptomatic volunteers, 37 women with frequency-urgency syndrome, 42 patients with mild stress urinary incontinence, and 18 with severe stress urinary incontinence. Transverse scanning over the midurethra was performed and cross-sectional images of the urethral and paraurethral structures were compared among the four groups, with P < 0.05 being considered statistically significant. The total cross-sectional area of the midurethra was significantly smaller in patients with stress urinary incontinence than in those without this disorder (86.7+/-29.9 versus 104+/-35.6 mm2, P = 0.005); this difference resulted from a significantly smaller peripheral striated muscle component in patients with stress urinary incontinence (42.8+/-20.7 versus 58.3+/-27.3 mm2, P = 0.001). The thickness of the urethropelvic ligaments was significantly thinner in patients with stress urinary incontinence than in those without (5.9+/-1.7 versus 8.9+/-2.1 mm, P < 0.001). The distribution of the peripheral striated muscle around the urethra was variable: complete surrounding the urethra was noted in 35.7% of the control women and in 48.6% of frequency-urgency patients, but only in 16.7% of patients with mild stress urinary incontinence and 5.3% of patients with severe disease. Bladder neck incompetence was seen in 42 patients with stress urinary incontinence but in none of the control women. The length of the pubourethral ligaments was similar in the four groups. Our finding showed that stress urinary patients had a smaller striated muscle component in the midurethra and thinner urethropelvic ligaments. These defects in the continence mechanisms might have great implications in the pathophysiology of stress urinary incontinence. Transrectal sonography of the urethra is a valuable investigative tool in assessing urethral and paraurethral conditions in patients with stress urinary incontinence before deciding treatment modality.     

When is surgery indicated for treatment of urinary stress incontinence?

Stress incontinence is the most frequent type of urinary incontinence in women. Its diagnosis and therapy is a so far not quite resolved problem. In particular conservative treatment and the decision-taking algorithm leading, after conservative treatment has failed, to selection of a suitable operation has undergone changes during the past 10 years. Classification of different risk groups of patients, the decision-taking algorithm, the most frequent mistakes and errors during conservative treatment, indication and implementation of surgery incl. the most frequent complications are the subject of the submitted paper.     

FPSUND: a pan-Canadian evaluation of a clinical classification of urinary incontinence

To obtain quantitative information on the risk of invasive cancers following a diagnosis of basal cell carcinoma (BCC) of the skin, patients with incident BCC cases listed in the cancer registries of the Swiss cantons of Vaud and Neuchatel between 1974 and 1994 were actively followed up through December 31, 1994, for the occurrence of subsequent invasive neoplasms. Among 11,878 persons with incident BCC who were followed for a total of 76,510 person-years at risk, 1,543 metachronous cancers were observed versus 1,397.9 expected, corresponding to a standardized incidence ratio (SIR) of 1.1 (95% confidence interval (CI) 1.0-1.2). However, after exclusion of skin cancers (mostly squamous cell carcinoma and melanoma), 975 second primary cancers were observed versus 1,059 expected (SIR = 0.9, 95% CI 0.8-1.0). Significant excesses were registered for cancer of the lip (SIR = 2.2), for squamous cell skin cancer (SIR = 4.5) and melanoma of the skin (SIR = 2.5), and for non-Hodgkin's lymphoma (SIR = 1.9). The SIRs were also above unity, though not significantly, for cancers of the salivary glands (SIR = 2.8) and the small intestine (SIR = 2.1) and for soft-tissue sarcomas (SIR = 1.7). The SIR for lung cancer was 0.9. The SIRs for salivary gland and skin cancer were appreciably greater below age 70 years. For most sites, particularly for squamous cell cancer and melanoma of the skin, the SIRs remained elevated 5 or more years after BCC diagnosis. The cumulative incidence of squamous cell skin cancer was 13% at 19 years; this stresses the importance of carefully monitoring skin lesions among persons previously diagnosed with BCC.