37 Clinical Trials for Various Conditions
This study looks at the best time to place a midurethral sling (MUS), which is a small piece of mesh used to treat stress urinary incontinence (SUI) (leaking urine when you cough, laugh, or exercise). The sling is placed during a type of surgery called robotic sacrocolpopexy (RSC). This surgery helps fix pelvic organ prolapse, when organs like the bladder or uterus drop from their normal place. Doctors can place the sling either before or after they lift and support the top of the vagina during surgery, but they aren't sure which timing works better. In this study, investigators are comparing what is the best time to place the sling, how the patient feels after surgery and if a patient's symptoms got better or worse.
Stress urinary incontinence (SUI) affects at least 40% of women in the United States. Synthetic polypropylene mid-urethral slings (MUS) are the gold standard treatment for SUI. Post-operative urinary tract infections (UTI) are one of the most common complications after MUS placement. Some studies have demonstrated that MUS placement can increase the risk of UTI up to 21-34%. Post-operative UTI can lead to significant healthcare and patient burden. This additional burden further contributes to an estimated annual cost of $1.6 billion for UTI management in the United States. With increased antibiotic usage, there is simultaneous increase in bacterial resistance leading to treatment refractory UTI. The investigators prescribe post-operative antibiotics prophylactically for 3 days after MUS placement with or without concurrent pelvic reconstructive surgery based on prior literature recommending post-operative prophylaxis. There is a greater emphasis on limiting antibiotic use given the trend of development of bacterial resistance. There are studies supporting alternatives such as methenamine for recurrent UTI prophylaxis treatment, but there are limited studies evaluating methenamine for UTI prophylaxis after MUS.
The purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.
The specific objective of this proposal is to evaluate pain and opioid use following a midurethral sling (MUS) under two different opioid prescribing schemes. The central hypothesis is that, in spite of the fact that opioids are often routinely prescribed by many surgeons following this procedure, most patients do not require them for pain control, and patients who are not prescribed postoperative will have similar pain scores and pain control satisfaction compared with patients who are routinely prescribed a standard amount of opioids for postoperative pain control.
This observational cohort study is aimed at determining changes in the cytokine expression profile as well as the urinary and vaginal microbiome of women undergoing midurethral sling placement for the treatment of stress urinary incontinence.
Stress urinary incontinence affects millions of women worldwide and has a profound impact on the quality of life of older individuals, their subjective health status, levels of depression and need for care. Midurethral sling placement was introduced in 1995 and remains the current gold standard for surgical management of SUI. Although the advantages of midurethral sling surgery include its high success and minimally invasive approach, approximately 10-50% of women experience acute postoperative urinary retention and are subsequently sent home with an indwelling foley catheter or clean intermittent self catheterization. Urinary retention is anxiety provoking for most patients and adds morbidity, cost, and increased utilization of healthcare resources. Additionally, catheterization of the urinary tract results in increased risk of urinary tract infection and potential need for antibiotics. Several recent studies have reported varying rates of postoperative voiding trial success depending on the type of local anesthetic used for hydrodissection; however the data is sparse and invites a more thorough investigation. Furthermore, to the investigators knowledge, no studies have systematically explored dosage or type of agent used intraoperatively on postoperative voiding function. Based on the preliminary data, the investigators hypothesize that patients receiving normal saline compared to a local anesthetic (e.g., lidocaine) will have a reduction in duration of postoperative urinary retention following retropubic midurethral sling placement.
The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.
The decision making process for stress incontinence surgery is complex. A key gap in the literature is how to improve patient preparedness and satisfaction for mid-urethral sling (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap. The specific aims of the proposed research: (1) is to develop two videos to counsel patients who have elected to undergo a MUS surgery. One video will be created from a patient-centered perspective using peers as counselors. The second will employ a traditional counseling approach; (2) To compare the impact of multimedia counseling between women randomized to a patient-centered counseling versus a traditional counseling video. The investigators will recruit patients who present with stress urinary incontinence who elect to undergo a MUS procedure. Women will be randomized during their pre-operative visit to watch the patient-centered or traditional counseling video before they are counseled regarding their upcoming MUS surgery in the usual manner. The investigators anticipate women randomized to a patient centered-video will report higher satisfaction, less decisional regret, greater preparedness, and less anxiety as measured by validated scales. Successful completion will improve understanding of patient's needs and will allow development of improved educational tools readily available to the AUGS community.
Urinary incontinence is a prevalent health and quality of life concern affecting almost half of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of many surgeons who perform midurethral sling surgery. All patients after outpatient midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be discharged without a catheter. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less post-operative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having midurethral sling surgery, either with or without vaginal prolapse repair.
Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is the only option which potentially offers a cure. It is well known that women with pelvic organ prolapse are at risk of developing new stress urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing, coughing, or laughing. Previous studies have demonstrated that the addition of a prophylactic anti-incontinence procedure at the time of prolapse surgery reduces this risk. One example of such a procedure is a mesh sling placed underneath the urethra (midurethral sling). Nevertheless, the decision to place a midurethral sling to prevent stress urinary incontinence after prolapse surgery remains controversial. A new risk calculator tool has been developed to provide patients' with their individualized risk of developing de novo stress urinary incontinence after prolapse surgery. The primary objective of this study is to determine whether use of this new personalized online risk calculator tool increases patient satisfaction with the decision whether or not to have a midurethral sling placed at the time of prolapse surgery to prevent development of stress urinary incontinence. The investigators hypothesize that use of this tool will increase patient satisfaction with their decision regarding midurethral sling placement.
The purpose of this research study is to better understand optimal restrictions for patients postoperatively following a mesh urethral sling placement for patients with stress urinary incontinence. Patients undergoing a midurethral sling procedure will be assigned to one of two groups. One group with be given standard postprocedural restrictions including instructions to avoid moderate activity and no lifting over 15lbs for six weeks after surgery. The other group will have fewer restrictions, with no restrictions on activity or lifting. Participants will complete surveys at 2 weeks, 3 months and 1 year following their procedure to help providers better understand how patients are following postoperative restrictions and if there were any differences in the outcome of the procedure between the two groups.
The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.
To assess to the non-inferiority of the retropubic Neomedic Knotless Incontinence Mesh (KIM) sling compared to the Gynecare Tension-free Vaginal Tape (TVT) Exact sling. Participants: Women 21 years or older with a diagnosis of stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with objective evidence of SUI planning surgery for stress urinary incontinence. Procedures (methods): Patients will be randomized to receive either the Gynecare TVT Exact sling or the retropubic Neomedic KIM sling. Patients will be followed for 1 year postoperatively.
Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
The primary objective of this project is to compare the rate of postoperative voiding dysfunction in two voiding trials (the retrograde-fill technique versus the spontaneous-fill technique) after midurethral sling (MUS) procedures with tension-free vaginal tape (TVT) without any concomitant surgery.
There has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. This study is designed to have two groups of patients. One group will receive pyridium pre-operatively, while the other group will have routine preoperative care. Both groups will have their bladder tested prior to going home. It will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.
This is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery.
Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many surgical procedures have been developed to treat SUI, and midurethral slings have gradually become the first line treatment. Voiding dysfunction, or inability for a patient to empty her bladder, immediately after surgery is common. A bladder test is often performed in the recovery area to see if the patient is able to empty her bladder. This typically consists of filling the bladder with 300 mL of saline through the foley catheter. The catheter is then removed and the patient is asked to void. The investigators then measure the voided volume and the residual left inside the bladder to determine if she is able to empty her bladder sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding trial that is initiated in the operating room. Our hypothesis was that a retrograde postoperative voiding trial initiated in the operating room would be as effective as a standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction while allowing for patients to spend less time in the recovery unit.
The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population. A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.
This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.
The purpose of this prospective cohort study is to investigate the effect of sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound and additionally compare the findings among women with successful vs failed surgical outcome.
There are no prospective, randomized studies addressing vaginal penetration restrictions following mid-urethral slings. There is a single cohort study examining expedited recovery following vaginal prolapse repair which advised 3-weeks of vaginal penetration restrictions. This study reported an earlier return to intercourse in the 3-week group than in the retrospectively collected control group where 6-weeks of restriction were advised. This study did not evaluate the impact of early versus later return to sexual activity on wound complications, mesh exposure rates, pain or satisfaction. It is important to develop evidenced-based recommendations on post-operative sexual activity restrictions. The purpose of this research study is to understand if the "standard" 6-week restriction on vaginal penetration/intercourse after mid-urethral sling affects patient satisfaction
SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.
Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a retropubic midurethral sling operation.
To determine the impact of unrestricted postoperative activity on intermediate- and long-term continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence. To assess the natural return to baseline activity level when patients are unrestricted following mid-urethral sling surgery with or without concomitant anterior or posterior pelvic organ prolapse repair.
Evaluate 5-year objective and subjective cure rates after implant of the retropubic Align Urethral Support System.
The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.
I. Specific Aims Pelvic organ prolapse is a common and distressing condition that is frequently associated with stress urinary incontinence (SUI) and often requires surgical repair. Abdominal sacral colpopexy is the preferred operation for repairing pelvic prolapse. As many as 91% of women with pelvic organ prolapse undergoing sacral colpopexy also experience SUI. In addition, up to 44% of previously continent women develop SUI incontinence after sacral colpopexy: perhaps because a sacral colpopexy may predispose to opening of the bladder neck if secured too tightly. The selection of a surgical procedure to prevent and manage SUI in women undergoing sacral colpopexy is empiric rather than evidence-based. Conceptually, a mid-urethral sling may be more effective than a Burch procedure for preventing urinary leakage because a sling provides outlet resistance beyond the bladder neck and therefore it may compensate for a downward tension on the bladder neck resulting from the sacral colpopexy. Indeed, clinical observations suggest that a mid-urethral sling is effective among women who have persistent urinary incontinence after sacral colpopexy with a Burch procedure. Therefore, the investigators' global hypothesis is that a mid-urethral sling is preferable to a Burch procedure for preventing and improving stress urinary incontinence in women undergoing sacral colpopexy for pelvic organ prolapse. The investigators' SPECIFIC AIMS are to evaluate objective and subjective outcomes at 6, 12 and 24 months in 124 women with urinary incontinence and advanced pelvic organ prolapse. All women will be undergoing a sacral colpopexy and will be randomized to either a Burch procedure or a mid-urethral sling. The primary endpoint is composite continence at 6 months while secondary endpoints will include composite continence and subjective measures of incontinence, patient satisfaction and morbidity associated with these procedures. The investigators' hypotheses are as follows: 1. At 6 months, urinary continence rates will be higher after a mid-urethral than after a Burch procedure. Urine continence will be assessed by composite measure of incontinence: no subjective complaint, no interim treatment, and negative standardized stress test performed by a masked observer. This assessment will be repeated at 12 and 24 months post-operatively to establish the medium term continence of the two procedures. Subjective continence and patient satisfaction measures will be obtained at each of the above visits using standardized questionnaires and pelvic organ support will be quantified by Pelvic Organ Prolapse-Quantification (POP-Q) scores. 2. Early events (e.g., blood loss, operative time, intra-operative complications (vascular, bowel and urological injuries), in-hospital complications (need for transfusion, febrile morbidity, thrombotic events, wound infection, length of stay, duration of bladder catheterization and ileus) and delayed postoperative complications (e.g., wound infection, mesh erosion, bowel obstruction and obstructed voiding) will be collected to compare the safety of each procedure.