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Biomedical subjects

G W Davila

Publications and source records attributed to G W Davila.

12 recordsLinked to original sources
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↗
PubMed1999

A bladder-neck support prosthesis for women with stress and mixed incontinence.

OBJECTIVE: To evaluate the safety and efficacy of a bladder-neck support prosthesis, a vaginal device designed to support the bladder neck, in women with genuine stress and mixed incontinence. METHODS: For enrollment, incontinent women underwent a history, physical examination including cotton-swab test, urinalysis, postvoid residual urine, and multichannel urodynamic testing. Those with genuine stress incontinence or mixed incontinence and urethral hypermobility completed 7-day bladder diaries, the Incontinence Impact Questionnaire, and underwent standardized pad tests. They were fitted with a prosthesis and seen weekly to optimize fit and efficacy. At week 5, they underwent repeat evaluations with the best-fitting prosthesis in place. RESULTS: Seventy women were enrolled and 53 completed the 1-month study (29 genuine stress incontinence, 24 mixed incontinence). The mean ages were 50.4 years for genuine stress incontinence (range 24-76) and 55.7 years for mixed incontinence (range 30-88). A statistically significant reduction in incontinence was noted on pad testing (genuine stress incontinence, mean 46.6-16.6 g; mixed incontinence, mean 31.9-6.8 g) and in the bladder diary (genuine stress incontinence, mean 28.6-7.8 losses per week; mixed incontinence, mean 30.2-15 losses per week). Quality-of-life scores improved in both groups. With the device in place, urodynamic testing indicated normalization of urethral function without evidence of outflow obstruction. Subjects found the device comfortable, easy to use, and convenient. Side effects included five urinary tract infections and 23 cases of vaginal mucosal soreness or mild irritation. CONCLUSION: The bladder-neck support prosthesis significantly reduced involuntary urine loss in women with stress and mixed incontinence.

Adult↗
PubMed1997

Introl bladder neck support prosthesis: international clinical experience.

The Introl bladder neck support prosthesis is a ring-shaped silastic device with two prongs located at one side such that when placed within the vaginal canal the bladder neck is suspended in a fashion similar to a surgical urethropexy. Since its initial description in 1988 the device has undergone clinical trials in the US and Japan, documenting its effectiveness in the treatment of stress and mixed incontinence in women. Introl is available for clinical use in the United States and has been well accepted by practicing clinicians. In Japan, exposure has occurred through clinical trials, which resulted in a high efficacy rate, i.e. 81% of the patients had either maximum benefit or benefit in the global usefulness rating, and 26% experienced minor adverse effects. This paper will summarize Introl clinical study findings and describe various clinical observations made during increased clinical usage.

Clinical Trials as Topic↗
PubMed1997

Clinical experience with a balloon-tipped urethral insert for stress urinary incontinence.

A balloon-tipped urethral insert for control of urinary incontinence in women has undergone clinical trials and has been accepted for clinical use by the U.S. Food and Drug Administration. On the basis of results of a multicenter clinical trial, it was concluded that the device provides a safe and effective option for management of genuine stress incontinence and mild mixed incontinence in women. This article reviews appropriate patient selection, education, and training to optimize patient acceptance and efficacy of this urinary control insert.

Adult↗
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↗
PubMed1996

Introl bladder neck support prosthesis: a nonsurgical urethropexy.

The Bladder Neck Support Prosthesis is a Silastic vaginal device designed to elevate and support the bladder neck and proximal urethra during stressful physical activities. It mimics the effects of a urethropexy on urethral function without resulting in urinary outflow obstruction. Recent clinical studies in women with stress and mixed incontinence have demonstrated significant objective reductions in involuntary urine loss and high subjective satisfaction ratings.

Bioprosthesis↗
PubMed1996

Topical 5-fluorouracil in the treatment of cervical human papillomavirus infection.

Chemosurgical treatment of vaginal/cervical human papillomavirus (HPV) infection with 5-fluorouracil (5-FU) is limited by vulvar pain and dysuria resultant from leakage and vulvar/urethral tissue reaction to the 5-FU. Women with cervical HPV DNA identified by in situ hybridization on colposcopically directed biopsy were treated with topically applied 5% 5-FU cream. A fitted cervical cap was used to restrict exposure to 5-FU. Repeat biopsies and in situ hybridization at least 6 weeks after application failed to detect HPV DNA in 6 of 7 patients. In 1 case, 5-FU treatment was associated with a decreased intensity of detectable HPV DNA. No episodes of vulvar pain or dysuria occurred. 5-FU can be used in the treatment of cervical HPV with minimal side effects when applied utilizing a cervical cap.

Administration, Topical↗
PubMed1996

Vaginal prolapse: management with nonsurgical techniques.

Obvious genital prolapse should not be ignored. Undoubtedly, it will progress, lead to worsening symptoms and alterations in pelvic function, and become more difficult to treat. Conservative management approaches include pelvic floor (Kegel) exercises for mild prolapse and use of vaginal pessaries to mechanically support prolapsed tissues. Comprehensive evaluation of bladder and urethral function should be done before any surgical repair is undertaken. Reconstructive surgery provides definitive therapy if all anatomic defects are addressed and the necessary lifestyle changes (eg, avoidance of exertional activities) are instituted.

Female↗
PubMed1994

The bladder neck support prosthesis: a nonsurgical approach to stress incontinence in adult women.

OBJECTIVE: Our purpose was to evaluate a vaginal device designed to support the bladder neck in women with urinary stress incontinence. STUDY DESIGN: Thirty-two physically active incontinent women underwent urodynamic evaluation and maintained a bladder diary before enrollment and after 4 weeks of device use. Outcome measures included changes in number of reported incontinence episodes, urine loss on stress testing, and changes in urodynamic parameters with the device in place. Patient comfort, convenience, and satisfaction were also evaluated. RESULTS: Thirty women completed the study. Twenty-five (83%) were dry with the device in place. Weekly incontinence episodes decreased from 10 to three (p < 0.05). Significant changes in functional urethral length, pressure transmission ratio, and urethral cotton swab stress angle were noted. No evidence of urethral obstruction was noted. The subjects found the device comfortable, easy to use, and convenient. CONCLUSION: The bladder neck support prosthesis reduces stress incontinence and normalizes urodynamic parameters in the same manner as a colposuspension.

Adult↗
PubMed1994

Urinary incontinence in women. How to help patients regain bladder control.

Urinary incontinence can have devastating effects on a woman's social life and physical activities. Simple diagnostic tools, including the Q-tip test and cystometry, can help identify the cause. Many causes are reversible, and an appropriate treatment regimen can bring improvement in or completely restore bladder control. Management options that may help patients avoid surgical intervention include bladder drills, pelvic floor muscle exercises, and functional electrical stimulation. Additional nonsurgical approaches are currently under investigation and should result in more options for treating urinary incontinence in women.

Female↗