Continence
One of the things that clearly distinguishes GBMC from its community hospital peers is the wealth of clinical trials offered to patients. The trials, many of which potentially have significant clinical impact, are open to all patients and are an important contribution to the advancement of medical care. Following are synopses of ten studies that are either currently open or have recently just been completed under the auspices of the Department of Gynecology, directed by Alfred Bent, MD, Chairman, and R. Mark Ellerkmann, MD. Sue Aumiller RN is the nurse in charge of research in the Division of Urogynecology/Reconstructive Pelvic Surgery. This Division includes other subspecialty-trained physicians including Michelle Germain, MD and Joan Blomquist, MD, as well as three fellows in training.
A multicenter study in the United States and Canada, open from June 2000 to June 2002, which treated patients who have stress incontinence with sphincter deficiency and an immobile bladder neck. The trial compared two periurethral bulking agents, bovine collagen (in use since 1993) and Uryx, a synthetic material made of ethylene vinyl alcohol copolymer dissolved in dimethylsulfoxide. GBMC has enrolled 9 patients, but the study has been done in many centers in the United States and Canada. “Normally, the collagen lasts a few months to two years,” says Dr. Bent. “We need a safe material that will last longer than the collagen, ideally permanently.” Preliminary results have shown that the new material is at least equal to collagen at one year, with more patients dry. Results will continue to be analyzed to review long-term outcome.
Transvaginal Tape (TVT) versus Suburethral Sling. This multicenter study is comparing the use of small mesh tape (TVT) to the standard suburethral sling procedure for patients who have sphincter deficiency and a mobile bladder neck. This trial started in December 2001 and will close in two years, with a total of 180 patients. The purpose of this study is to determine if the TVT is as good as the sling (the TVT is an easier procedure).
Multicenter study comparing three techniques to repair symptomatic rectocele (pelvic organ
prolapse): traditional repair, site-specific repair, and site-specific repair with biomaterial augmentation. The two-year study opened in fall 2001 at three sites in Maryland, including GBMC, Johns Hopkins and the University of Maryland. Thus far, GBMC has enrolled 14 women in the study. Patients are randomly assigned to one of the three study arms. (Traditional repair uses tissues surrounding the bulge to plicate the bulge. Site-specific repair fixes a defect in the tissue. Site-specific repair with biomaterial augmentation fixes a defect in the tissue and then augments the repair with a covering of biomaterial.)
This multi-center study with physicians at GBMC, Johns Hopkins, Dartmouth-Hitchcock Medical Center and the University of Texas Southwestern Medical Center is testing two types of pessaries, a Ring Pessary and a Gelhorn Pessary. Pessaries are used to help women with pelvic organ prolapse. Patients are randomized prospectively, alternately using each pessary for 12 weeks each. At the end of 6 months, they select the preferred pessary, and follow-up continues at one year. Study enrollment will end March 1, 2003. Over 150 patients have been enrolled to date, and results will not be published until 2004.
Pilot study to assess the efficiency of two biomaterials, SurgiSIS and Alloderm, for use in reconstructive pelvic surgery (repair of rectocele and cystocele). In 46 patients who were compared to controls, the data showed that there were no adverse effects, including quality of life issues, from using either biomaterial.
200 patients undergoing outpatient urodynamic testing and cystourethroscopy took part in a study at GBMC that compared perceived pain and actual, realized pain. Before their procedure, patients were asked to indicate on a pain scale the extent of expected pain. After the procedure, they were asked to rate the actual pain. Data analysis demonstrated that patients actually anticipate that they will experience more discomfort than then actually perceive during either procedure.
This study was designed to compare autologous fascia lata slings to Tutoplast (cadaveric fascia lata). A total of 40 patients who underwent Tutoplast fascia lata suburethral sling operations will be compared to patients who underwent autologous fascia lata slings Subjective parameters including quality of life indicators as well as objective urodynamic testing (measurement of bladder function) will be compared and the data will be analyzed to see if Tutoplast is as effective as autologous fascia lata for the treatment of stress urinary incontinence.
A study evaluating continence surgery with abdominal repair of prolapse is about to commence as part of a multicenter study sponsored nationally by the NICHD Council for the Clinical Trials Network for Female Pelvic Floor Disorders. Patients with severe prolapse of the vaginal vault after hysterectomy will be randomly assigned to have or not have an additional surgery to prevent urinary incontinence at the time of their abdominal repair for the prolapse (abdominal sacrocolpopexy).
A study on the use of biofeedback is being conducted on patients having pelvic floor rehabilitation as primary treatment for urinary incontinence. Patients are randomly assigned to receive or not receive the additional biofeedback therapy for management of stress, urge, and mixed incontinence. It is expected that 75 patients will be enrolled in each arm of the study.
The Department of Gynecology will participate in a study evaluating follow-up of abnormal PAP smears including colposcopy, biopsy, and treatment modalities. The object of the trial is to determine the most efficient and safe manner in which to track these patients.
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