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Biomedical subjects

A Diokno

Publications and source records attributed to A Diokno.

16 recordsLinked to original sources
PubMed2001

A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere.

OBJECTIVES: To assess the safety and effectiveness of Durasphere compared with bovine collagen in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). METHODS: This multicenter, randomized, controlled, double-blind trial was composed of 355 women diagnosed with SUI due to ISD and used a standardized pad test and the Stamey continence grade as the primary endpoints. The participants' ages ranged from 26 to 84 years. All patients had an abdominal leak point pressure of less than 90 cm H(2)O (average 51). RESULTS: At 12 months after the first injection, the two materials were equivalent with respect to the improvement in continence grade and pad weight testing. Less Durasphere was injected to obtain comparable clinical results (Durasphere 4.83 mL versus bovine collagen 6.23 mL, P <0.001). When examined 1 year after the date of the last treatment, 49 (80.3%) of the 61 women treated with Durasphere showed improvement of 1 continence grade or more compared with 47 (69.1%) of 68 women treated with bovine collagen (P value for difference = 0.162). Although the adverse events reported for both groups were similar, the Durasphere group had an increased short-term risk of urgency and urinary retention. CONCLUSIONS: The use of Durasphere for the treatment of SUI due to ISD was equally effective as bovine collagen and used less material. The U.S. Food and Drug Administration granted market approval for Durasphere on September 13, 1999. The product design and initial clinical data suggest the potential for greater durability of the clinical benefit, with the possibility of a permanent solution for SUI due to ISD in some patients.

Adult↗
PubMed2001

Factors associated with clinical assessment of overactive bladder and selection of treatment.

BACKGROUND: Overactive bladder (OAB) affects >17 million individuals in the United States, but the symptoms of OAB are frequently underreported by patients and therefore untreated by physicians. OBJECTIVE: The purpose of this observational study was to investigate the demographic and clinical factors associated with the decision to treat OAB pharmacologically and identify factors associated with physicians' assessment of symptom severity. METHODS: We studied 31 physicians treating 217 patients with OAB and collected data on patient demographic characteristics, OAB symptoms, previous management strategies, physicians' assessments of OAB severity, and treatment prescribed. Stepwise logistic regression was used to identify factors associated with selecting pharmacologic treatment and with physician assessment of severity of OAB symptoms. RESULTS: The mean age of the patients was 61.3 years; approximately 82% were female, and approximately 73% were white. Participants with urinary incontinence were significantly (P < 0.001) more likely to be treated with medication than were those with only symptoms of nocturia or urinary frequency. Other significant factors associated with pharmacologic treatment were being white (odds ratio [OR], 9.5; 95% CI, 2.9-30.8); being black (OR, 5.9; 95% CI, 1.2-29.7); physician's clinical assessment of OAB as moderate (OR, 3.5; 95% CI, 1.5-8.2) or severe (OR, 3.8; 95% CI, 1.1-13.7); previous use of medication (OR, 2.9; 95% CI, 1.1-8.1); and number of incontinence episodes in the last 24 hours (OR, 1.2; 95% CI, 1.0-1.5). Factors associated with physician assessment of OAB severity included distress due to OAB symptoms (OR, 2.1; 95% CI, 1.3-3.2), number of incontinence episodes in the last 24 hours (OR, 1.2; 95% CI, 1.1-1.4), and use of previous treatment(s) (OR, 0.4; 95% CI, 0.2-0.8). CONCLUSIONS: Both demographic and clinical symptoms of OAB were associated with the decision to treat OAB with medication, whereas physicians' assessment of OAB severity was associated only with clinical symptoms. Urinary incontinence was the key symptom associated with the decision to treat patients with medication and with the assessment of OAB symptom severity.

Aged↗
PubMed1999

The role of androgen deprivation in the definitive management of clinically localized prostate cancer treated with radiation therapy.

PURPOSE: Multiple studies exploring the use of androgen deprivation given in combination with radiotherapy (RT) for localized prostate cancer have reported significant improvements in the rates of local, regional, and biochemical control (BC). The impact of this therapeutic strategy on overall and cancer specific survival (CSS) has not been established, however. We performed a MEDLINE search of all available studies on this topic to determine if any conclusions could be reached on the efficacy of this treatment approach and the patients most suitable for its application. MATERIALS AND METHODS: A MEDLINE search was conducted to obtain all articles in the English language on the use of androgen deprivation in combination with RT for the treatment of localized prostate cancer. The medical subject headings (MeSH) used to search the MEDLINE database included: a) prostatic neoplasms; b) prostatic neoplasms/radiotherapy; c) prostatic neoplasms/androgen deprivation; d) hormone therapy; e) English; and f) 1980 to 1998. RESULTS: A total of 14 retrospective studies were identified that compared some form of androgen deprivation given in combination with RT. Most studies showed significant improvements in various measures of local/regional control and disease-free survival (DFS). Three of four studies that analyzed BC rates showed significant improvements in this endpoint but conflicting results were obtained for overall survival (OS). No study showed an improvement in CSS. Six prospective randomized trials were identified that directly compared RT with or without androgen deprivation. Again, all six studies showed improvements in some measure of local/regional control or DFS but only two studies showed an improvement in OS. One study reported a statistically significant improvement in CSS and another study showed an improvement in the rate of negative biopsies with combined treatment. CONCLUSIONS: When all available literature on androgen withdrawal given in combination with RT for the definitive treatment of localized prostate cancer was reviewed, no definite conclusions could be reached on the impact of this treatment approach on OS and CSS. However, local/regional control, DFS, and BC were almost uniformly improved with the use of androgen withdrawal suggesting that these impressive early results may translate into improved cure rates. Data from recently initiated and completed randomized trials will be needed, however, to define the impact of this approach on cancer specific mortality and the patients most suitable for it's use.

Androgen Antagonists↗
PubMed1999

Effect of a urinary control insert on quality of life in incontinent women.

The aim of the study was to evaluate the efficacy, safety and effect on quality of life of the Reliance urinary control insert (Uromed Corp., Needham, MA) in women with genuine stress incontinence. Efficacy was evaluated at baseline and at the end of the 12-month study period by standardized pad-weight studies and by rating scales measuring acceptability, incontinence symptom improvement, ease of learning, comfort and time to habituation, recorded in diaries at monthly intervals in 63 women. The SF-36 Health Survey questionnaire was used to assess quality of life status at baseline without the device and after 12 months of device use. A significant decrease in urine loss at 12 months compared with baseline was shown by standardized pad-weight studies, with and without the device in situ. Urine loss was reduced by more than 80% in 91% of the 63 patients, and 79% were completely dry. Patient diaries showed significant improvement in control of leakage, comfort, and ease of device use during the study period. Short-term-36 Health Status data also indicated significant improvement in the physical functioning score at 12 months. Urinary tract infection and hematuria were the most common adverse effects. The Reliance urinary control insert is an efficacious and safe means of controlling genuine stress incontinence in women. The device was perceived as easy to use and comfortable for these 63 women, and resulted in improved quality of life.

Adolescent↗
PubMed1997

The efficacy of intravesical Tice strain bacillus Calmette-Guerin in the treatment of interstitial cystitis: a double-blind, prospective, placebo controlled trial.

PURPOSE: Interstitial cystitis is a debilitating bladder disease of unknown etiology with no cure. A recent report suggested that bacillus Calmette-Guerin (BCG) may be effective in the treatment of interstitial cystitis. A randomized, prospective, double-blind, placebo controlled trial to evaluate the safety and efficacy of intravesical BCG in treating interstitial cystitis was done. MATERIALS AND METHODS: Patients meeting the National Institute of Arthritis, Diabetes and Digestive and Kidney Diseases criteria for interstitial cystitis received 6 weekly instillations of Tice strain BCG or placebo. Periodic questionnaires, voiding diaries and cystometrograms were obtained. A total of 30 evaluable subjects was enrolled in the study with a mean followup of 8 months (range 6 to 13). Based on an exit questionnaire a responder was defined as one who rated the interstitial cystitis symptoms as moderately improved or better. RESULTS: A 60% BCG response rate was noted, compared to a 27% placebo response rate. Minimum voided volume and quality of life improved in the BCG group compared to placebo. Adverse events were similar in each group, mostly irritative in nature, and no significant systemic events were noted. CONCLUSIONS: Intravesical Tice strain BCG appears to be safe and efficacious in the treatment of interstitial cystitis. Additional studies must be performed to confirm the results of this pilot study.

Adjuvants, Immunologic↗
PubMed1996

Effectiveness of a urinary control insert in the management of stress urinary incontinence: early results of a multicenter study.

OBJECTIVES: The purpose of this study was to test the safety and effectiveness of a urethral insert for managing stress or mixed urinary incontinence. METHODS: We performed a prospective, multicenter study of 135 female patients who were treated for 4 months with the Reliance Urinary Control Insert. The effectiveness of the insert was measured objectively at the time of first use and after 4 months' use by standardized pad weight studies. Insert effectiveness was also measured by reports of symptom improvement during patient interviews and on patient diaries. Urine microscopy and culture were obtained monthly; cystoscopy and urodynamics were conducted at study entry and at 4 months. RESULTS: Significant improvement in involuntary urine loss was observed. Objective measurement of urine loss revealed that 80% of the patients were completely dry, and 95% of the patients achieved greater than an 80% decrease in urine loss. In addition, patients' perceptions of acceptability, incontinence symptom improvement, ease of learning, comfort, and time to habituation also showed improvements. Untoward events reported during the study included hematuria, bacteriuria, and bladder irritation. These events did not require significant medical intervention and did not result in any long-term clinical sequelae. CONCLUSIONS: These preliminary results indicate that the Reliance Urinary Control Insert may be a safe, effective, and well-tolerated alternative to other available methods for the management of stress or mixed incontinence in women. Additional long-term follow-up will be required to substantiate this conclusion.

Adolescent↗
PubMed1995

Preference, compliance and initial outcome of therapeutic options chosen by female patients with urinary incontinence.

PURPOSE: We determined the patient preference for, compliance with and initial outcome of either behavioral modification, pharmacotherapy or surgery for urinary incontinence. MATERIALS AND METHODS: A total of 150 incontinent women underwent basic evaluation based on Agency for Health Care Policy and Research urinary incontinence guidelines. Options were presented and the chosen modality was evaluated at 4 to 6-week intervals. RESULTS: Of the patients 61% chose behavioral modification, 25% chose pharmacotherapy and 14% chose surgery. The dropout rate was 33% (50 of 150 women), including mostly those on behavioral modification. Of the remaining patients 74% on pharmacotherapy and 73% on behavioral modification reported marked improvement. CONCLUSIONS: When given options, patients chose nonoperative measures first. Compliance was poor among patients who chose behavioral modification.

Adult↗
PubMed1994

Improved local control and survival for surgically staged patients with locally advanced prostate cancer treated with up-front low dose rate iridium-192 prostate implantation and external beam irradiation.

PURPOSE: In an effort to improve upon the historically poor local control and survival rates for locally advanced prostate carcinoma, a prospective multidisciplinary clinical trial was initiated using low dose rate Iridium-192 prostate implantation and external beam irradiation. METHODS AND MATERIALS: Between January 1983 and September 1989, 57 patients with newly diagnosed bulky prostatic carcinoma (5 Stage B2, 52 Stage C) were treated at the Mayo Clinic (34 patients) and William Beaumont Hospital (23 patients) with (a) 5 Gy delivered preoperatively in one fraction, (b) pelvic lymphadenectomy with interstitial implantation of the prostate using Iridium-192 seeds via a perineal template to 30-35 Gy, and (c) 30.6 Gy external irradiation to prostate only in 17 fractions. RESULTS: After lymphadenectomy, 30/57 (53%) patients had pathologically confirmed positive lymph nodes or "D1" disease. Thirty-four patients (60%) had Gleason scores > or = 7. Mean age at diagnosis was 63.3 years. Median overall follow-up was 72 months. The 5-year actuarial survival rate was 85% and disease-free survival was 63%. The 5-year survival for patients with negative nodes was 93% and with positive nodes was 79%. The corresponding survival for patients with Gleason scores < or = 6 was 96% and > or = 7 was 78%. Multivariate analysis demonstrated that of all covariates considered, only Gleason score had prognostic significance for disease-free survival (p < 0.05) and no covariates were statistically significant for overall survival. Thirty-nine of the 57 patients had a prostatic re-biopsy performed at 18 months. Pathologically confirmed local control was ultimately achieved in 31/39 (79.5%). There was no difference in survival in patients with positive re-biopsies vs. those with negative results. The 5-year actuarial rate of clinical local control was 94%. Three patients clinically failed locally and 21 demonstrated distant progression. The median time to progression was 34 months. Nineteen percent received some form of hormonal manipulation at the time of their treatment course and an additional 42% were treated with hormones during their follow-up period, primarily after distant failure. The grade 4 rectal ulceration rate decreased to 4.5% with modification of the brachytherapy technique. Three patients experienced grade 4 urinary incontinence and three patients experienced grades 3 or 4 chronic perineal pain. CONCLUSION: These results indicate that bulky prostate carcinoma can be successfully controlled locally by this novel and aggressive approach with moderate toxicity and improved survival.

Adenocarcinoma↗
PubMed1993

Use of artificial sphincter to bowel segment using rectus muscle interposition.

The use of artificial urinary sphincter around the urethra or bladder neck for the management of urinary incontinence secondary to intrinsic urethral sphincter deficiency is now well accepted. However, its use around the bowel to serve as a sphincter in urinary pouches is still anecdotal. Its use in experimental models has been met with failure because of ischemic bowel necrosis at the cuff site. To obviate these difficulties, a new technique was devised using a flap of rectus muscle that acted as a cushion between the cuff and the bowel wall. Results in five dogs showed that bowel wall ischemia is avoided with cuff pressure of 51-60 cm applied constantly for four weeks while providing pressure to leak around the closed cuff with a pressure of 62-75 cm water. Further study is needed to confirm the long-term effect of this technique on the bowel wall and the ability of the sphincter to maintain continence.

Abdominal Muscles↗
PubMed1992

An annotated algorithm approach to clinical guideline development.

The Urinary Incontinence in Adults Guideline Panel facilitated the ready elucidation of its guideline's management recommendations through the use of an annotated algorithm approach. The algorithms created as part of this guideline differ from previous algorithms in two ways: (1) they employ systematic annotation to link explicitly the algorithms' recommendations to the literature, and (2) they contain patient counseling and decision nodes to depict the major preference-dependent decision or branch points in the algorithm. We believe that these two innovations can help ensure the clinical validity of guidelines' algorithms while preserving appropriate clinical flexibility and respecting patient preferences.

Algorithms↗
PubMed1989

Pelvic lymphadenectomy and transperineal interstitial implantation of IR 192 combined with external beam radiotherapy for bulky stage C prostatic carcinoma.

From January 1983 until June 1987, 51 patients with locally advanced prostatic carcinoma (47 Stage C, 4 bulky B2) were treated at Mayo Clinic (33 patients) and at William Beaumont Hospital (18 patients) with (a) 5 Gy delivered pre-operatively in one fraction, (b) pelvic lymphadenectomy and (c) interstitial implantation of the prostate with Ir 192 seeds via a perineal template (the Martinez Universal Perineal Interstitial Template) to deliver 35 Gy, and (d) 30.6 Gy external beam therapy in 17 fractions to prostate only fields. Initial clinical response has been excellent. Local control, with a median follow-up of 45 months, has been 100% by clinical exam and 84.5% pathologically in the subset biopsied. Disease-free actuarial survival at 5 years is 89%. Major toxicity has been limited to the rectum, but a modification of the brachytherapy technique has reduced this sharply. We conclude that bulky Stage C prostatic carcinoma can be successfully treated by this aggressive combination of modalities with acceptable toxicity.

Adult↗
PubMed1978

The anticholinergic effects of dicyclomine hydrochloride in uninhibited neurogenic bladder dysfunction.

A preliminary study to assess objectively the effects of dicyclomine upon uncontrolled detrusor contractions and bladder capacity was undertaken in 14 patients with a cystometric diagnosis of uninhibited neurogenic bladder. Response was measured by cystometry performed 1, 2 and 4 hours after a 20 mg. oral dose. Of the 14 patients 11 had significant blockade of uninhibited contractions and a concomitant increase in bladder capacity. Similar but less dramatic changes were noted in the remaining 3 patients. Dicyclomine seems to have effective anticholinergic properties. No remarkable side effects were observed.

Adult↗