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Incontinence clinical trials

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NCT ID: NCT05116592 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

The Risk Factor and Outcome of Transient Incontinence After Prostate Enucleation Surgery

PPI
Start date: April 1, 2020
Phase:
Study type: Observational

Lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH) are the most common urological problem among men. monopolar transurethral resection of the prostate (TURP), in which the enlarged prostate tissue is resected piece by piece using a monopolar electrode, has been the gold standard since the 1970s. It can substantially improve the maximal flow rate (Qmax), urinary symptoms (International Prostate Symptom Score, IPSS), and health-related quality of life (QOL), with long-term efficacy compared to medications or other minimally invasive treatments.4 5 However, monopolar TURP is a risky procedure because of the likelihood of severe complications such as massive bleeding or transurethral resection (TUR) syndrome.6 Therefore, it is of paramount importance to develop minimally invasive surgical techniques with outcomes similar to those of monopolar TURP, but with fewer side effects. Therefore, new energy system with different surgical methods developed after 2000s. Among all, Enucleation methods was proved to have better Qmax and IPSS after surgery than vaporization and resection methods. However, the risk of short-term transient incontinence was higher in enucleation than in resection methods. Hence modified methods such as upside down, apical preservation methods, defining the limits of dissection proximal to external sphincter prior to enucleation of prostate were developed in order to reduce transient incontinence. Besides, the necessity of preoperative urodynamic study and biofeedback training, investigate the risk factors of transient incontinence are important issues. The study using prospective cohort design recruit 300 BPH patient receiving enucleation methods. To investigate the risk factors of transient incontinence and establish model to predict the incontinence. Besides we will evaluate different surgical methods and treatment methods to improve transient incontinence and the long-term results of different enucleation methods.

NCT ID: NCT04762381 Recruiting - Pain, Postoperative Clinical Trials

Dexamethasone and Robotic-assisted Hysterectomy

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Robotic-assisted hysterectomy is an alternative to laparoscopic surgery as part of a minimal invasive regimen. Several treatment strategies are followed to improve the overall outcome and minimize surgical stress. Glucocorticoids provide significant analgesic and antiemetic effects but its role in a fast-track, multi-modal setting is not settled when discharge is planned within 24-36 hours. This study will evaluate in a randomized trial the effect of a single dose of 24 mg dexamethasone on women undergoing robotic-assisted hysterectomy with regard to surgical stress measured by c-reactive protein as primary outcome and, further, other stress markers like white blood cells, Il-6, cortisol, and creatinine kinase. The postoperative recovery will be registered in validated charts and questionnaires for pain and analgesic use, quality of recovery, incontinence, sexual and work life. Furthermore, in a sub-analysis, transcriptional profiling will be applied to explore, which parts of the innate and cellular immune system is activated to explore the mechanisms of surgical stress response. The hypothesis is that women undergoing robotic hysterectomy would benefit from peroperative glucocorticoid treatment on important life qualities like pain, fatigue, freedom of medications and resuming work and sexual activities. Further, future adjuvant peroperative regimens may be able to target the stress response in a more appropriate way

NCT ID: NCT04110821 Recruiting - Quality of Life Clinical Trials

Quality of Life After Conservative and Surgical Treatment of Pelvic Organ Prolapse

LOLIPOP
Start date: September 15, 2019
Phase:
Study type: Observational [Patient Registry]

This is an observational study that gives baseline and follow-up information, that does not directly influence the allocation of patients to various treatment Options (conservative and surgical therapy of Pelvic Organ Prolapse) but the knowledge gained of the data will help to develop treatment strategies.

NCT ID: NCT04010292 Recruiting - Incontinence Clinical Trials

Enhancing Patient Recall in Urogynecologic Surgery

Start date: November 14, 2019
Phase: N/A
Study type: Interventional

Patient counseling is an essential part of any new treatment implementation. This process becomes even more important when it involves surgical counseling. This is when the patient and the surgeon discuss the possible surgical options and ideally establish a plan for the appropriate surgical intervention. Unfortunately, multiple studies have shown that patients tend to have poor recall of the key elements discussed during the consultation (1-3). In the investigators' experience, the concern lies specifically in the level of recall that patients have regarding their planned surgical procedure, as most patients cannot correctly state the planned intervention despite extensive counseling and explanation. Lack of knowledge about the type of surgery can have serious implications for the patient in the future. For example, knowing facts like the presence or absence of the cervix and whether future pap smears are needed or the presence of an implant, such as a mesh are necessary for the patient's well-being and proper medical care down the line, especially when the patient has multiple medical providers. In addition, previous research has demonstrated that low-quality counseling and the feeling of being "unprepared for surgery" directly correlate with patient dissatisfaction (4). This is especially relevant in the field of female pelvic reconstructive surgery, where the success of surgical interventions relies heavily upon subjective patient-reported outcomes (5). There have been many studies to augment the counseling process using supplemental materials. These have included use of multiple visual charts, anatomical models, and passive and interactive audiovisual aids (6). Some improvement in the outcomes has been observed in various fields of medicine with the dissemination of supplemental patient resources (7-10). However, in urogynecology, the effectiveness of surgical counseling sessions has not been achieved despite the different additional methods for patient education (6, 11). Reasons that urogynecologic supplemental materials have not seen the same level of success as those in other fields of medicine include the complexity of the surgeries and the language used in many of these educational aids (12). The investigators aim to address the problem of poor patient recall of their procedure by providing them with an easy-to-read patient card detailing the anticipated surgery at the time of their consult.

NCT ID: NCT03051321 Recruiting - Incontinence Clinical Trials

Maintaining Lower Levels of Care Through Automated Perineal Hygiene

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

The inability to independently manage perineal hygiene after toileting is a common issue for those in assisted living and nursing home environments. It is associated with skin breakdown (dermatitis), increased nursing costs, and loss of patient self-esteem and independence. Water-based toileting has been evaluated as a possible adjunct to patient care, but its uptake has been limited by ineffective cleansing and drying. 40 subjects with limitations in independent capacity for perineal hygiene that require assistance with toileting will be recruited from a continued care retirement center. Subjects will be assessed for incontinence, and skin breakdown or irritation. Subjects will be provided a Wellness Toilet System, cleanser, and, if needed, zinc oxide barrier spray to be applied in cases of dermatitis. Investigators hypothesize that subjects given the device will remain more independent, with higher quality of life. Secondary hypotheses are that subjects will experience improved relationships with their caregivers, and that active dermatitis will be treated in those already with the condition, and prevented in those at risk.

NCT ID: NCT02978638 Recruiting - Spinal Cord Injury Clinical Trials

Electrical Stimulation for Continence After Spinal Cord Injury

Start date: September 2014
Phase: N/A
Study type: Interventional

This study aims to improve continence and voiding of patients with spinal cord injury using electrical stimulation. The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving bladder and bowel function in patients with spinal cord injury (SCI). It has been commercially available in Britain and other countries since 1982, and has been used in thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing urination on demand and to aid in bowel evacuation. Electrical stimulation to produce bladder contraction and improve bladder voiding after spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex contraction of the bladder, which improves continence. However, cutting these nerves has undesirable side effects. This study will not cut any sensory nerve. This study is testing the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to improve continence after spinal cord injury, and for blocking sphincter contraction to improve voiding.

NCT ID: NCT02306382 Recruiting - Incontinence Clinical Trials

Multicenter Study for Diagnosis and Treatment of Perianal Abscesses

Start date: December 2012
Phase: N/A
Study type: Interventional

Drainage of perianal abscesses is a well established treatment. Traditionally its been done in general anesthesia after the swelling has been localised its been drained with a knife. After surgical intervention complications can occur with recidivism, chronic fistulas that go from the anal to the skin and sometimes the anal sphincter is damaged which can cause problems with incontinence. Through ultrasound the abscess is opened under more controlled forms with a better visual overview. This is a new technique that has not been tested in larger studies. The aim with ultrasound-drainage as with traditional incision to drain the abscess so that the infected area can heal. The hypothesis is a reduction of recurrences and formation of fistulas with the use of 3D ultrasonography.

NCT ID: NCT02185235 Recruiting - Clinical trials for Pelvic Organ Prolapse

A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder

Start date: June 2014
Phase: N/A
Study type: Interventional

Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse (POP), and fecal incontinence-which often occur together. Pelvic floor disorders impair multiple aspects of the life quality, including the sexual function of women. Surgery became the first choice of treatment, however, and not until 1980s was the renewed interest in conservative therapies. This may be because of higher awareness among women and cost of and morbidity after surgery. The conservative treatment included pelvic floor muscle training, electrical stimulation, vaginal cones, and biofeedback. The outcome was up to 35~70 % improved rate as the literature before. Current guidelines recommended conservative management as a first-line therapy. However, there was no consistent consensus on this issue due to variations in stimulation parameters、adjuvant concurrent modality or duration of treatment course, and insufficient result about large and long term follow up of randomized- controlled studies. Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary incontinence, chronic pelvic pain etc.). At the aspect of Quality of life, our studies tried to focus on the different domains of pelvic disorder and sexual quality by means of validated questionnaire more objectively.

NCT ID: NCT02091947 Recruiting - Incontinence Clinical Trials

Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

FMS
Start date: November 2010
Phase: Phase 2
Study type: Interventional

Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.

NCT ID: NCT02030340 Recruiting - Incontinence Clinical Trials

Comparison of Air Charged Catheters With Water Filled Catheters for Urodynamic Study

ACWF
Start date: December 2013
Phase: N/A
Study type: Observational

Various systems to measure intravesical and intrarectal pressure during urodynamic testing; especially cystometry, exist. Water filled tube -systems are the most commonly used and should be regarded as the contemporary standard. A water filled system is however sensitive to tube and or patient movement artefacts and prone to erroneous calibration. Air charged catheters are less sensitive to patient and especially tubing- movements, and calibrate easier. However, in vitro tests have demonstrated that air charged catheters respond somewhat slower and relatively damped, especially to rapid pressure changes as in (simulated) coughing, in comparison with water filled systems. The clinical relevance of these observations is unknown. This is a study to compare the technical reliability and clinical applicability of the two types of catheter systems for cystometry in a synchronous double catheter testing procedure in a prospective group or patients scheduled for urodynamic investigation.