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Urinary Incontinence, Stress clinical trials

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NCT ID: NCT04444830 Withdrawn - Surgery Clinical Trials

Sprix for Postoperative Pain Control Following Gynecologic Surgery

Start date: January 2021
Phase: Phase 4
Study type: Interventional

The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients' perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of opioids that be may prescribed after acute injury, for chronic conditions and following surgery the healthcare industry as a whole continues to search for alternative medications that provide adequate pain relief and have a reduced tendency for abuse/dependence/addition. To that end this study has the following aims: 1. To evaluate the amount of opioids consumed following minimally invasive, female pelvic surgery when patients' postoperative pain is managed via: 1. Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol) 2. Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough pain (Sprix protocol) 2. Patient satisfaction with the aforementioned methods 3. Evaluate and compare pain scores via validated questionnaire Hypothesis: Primary: 1. Patients prescribed intranasal Ketorolac (Sprix protocol) will consume significantly less Morphine Milliequivalents (mEqs) of narcotics compared to the standard protocol following minimally invasive female pelvic surgery. Secondary: 1. Patients in the Sprix protocol will have lower Visual Analog Scale (VAS) measures of pain which will be measured on a 0-10 scale where 0 denotes no pain and 10 denotes maximum experience of pain 2. Patients in the Sprix protocol will have lower numeric pain score and on POD#4 3. Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores on POD#1 4. Patients in the Sprix protocol will have higher QoR-40 scores on POD#4 5. Patients will not have any significant difference in overall surgical satisfaction on POD#1 and POD#4 using a numerical satisfaction score 6. Patients in the Sprix protocol will be more likely to consume no narcotics at all once discharged to home

NCT ID: NCT04412876 Withdrawn - Clinical trials for Stress Urinary Incontinence

Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

Start date: May 31, 2020
Phase: Phase 3
Study type: Interventional

To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

NCT ID: NCT04253067 Withdrawn - Clinical trials for Urinary Incontinence

A Single-Blind, Randomized Study to Compare fCO2 Laser Therapy Versus Sham for Treatment of SUI in Women

LaserSUI
Start date: October 2020
Phase: N/A
Study type: Interventional

This is a prospective randomized sham-controlled study of patients undergoing vaginal treatment with a fractional carbon dioxide (fCO2) laser for stress urinary incontinence (SUI) symptoms. Eligible participants will be randomized (like a flip of a coin) to receive active or sham fCO2 laser treatments. Three treatments with the fCO2 laser or sham to the vagina will be performed, approximately four weeks apart.

NCT ID: NCT04133935 Withdrawn - Clinical trials for Stress Urinary Incontinence

Treating Stress Urinary Incontinence: Laparoscopic Obturator Urethropexy vs Burch Urethropexy

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Stress urinary incontinence (SUI) is a highly prevalent concern within the female population. Although mid urethral slings (MUS) have been the first line treatment for SUI for almost twenty years, due to recent FDA warnings and many countries banning the use of vaginal mesh, a significant portion of patients now request non-mesh anti-incontinence procedures. In such cases, Burch colposuspension would be the next option discussed with patients. In the short term, the efficacy of Burch colposuspension is comparable to MUS. However, the noteworthy disadvantages of Burch colposuspension include a high rate of urinary retention. This increased risk of urinary retention is due to the acute angle of the stitches, and is a problem that Burch colposuspension shares with the retropubic sling, a type of acutely-angled MUS. A variant of the retropubic sling, the transobturator tape (TOT), has shown that a rounder angle of elevation significantly reduces the risk of urinary retention. As such, this study proposes a novel technique of laparoscopic obturator urethropexy (LOU) as an alternative to the traditional Burch colposuspension. In this new proposed technique, stitches are placed into the obturator internus fascia rather than Cooper's ligament, reducing the angle of elevation of the bladder neck, aiming to lower the risk of post-operative urinary retention. The aim of our randomized control trial is to assess the effectiveness of LOU compared to Burch colposuspension in terms of urinary continence. Our secondary aim is to report on perioperative and postoperative complications, functional outcomes including urinary retention, recurrent urinary tract infection, recurrent/persistent urgency, de novo urgency, recurrent SUI, and sexual function, as well as overall quality of life.

NCT ID: NCT04114019 Withdrawn - Clinical trials for Stress Urinary Incontinence

The Effect of Pelvic Floor Physiotherapy on Vaginal Elasticity

Start date: July 1, 2020
Phase:
Study type: Observational

Women suffering from stress urinary incontinence are offered pelvic floor physiotherapy as an optional treatment. Strengthening of the pelvic floor is measured to date by manual examination and lacks precise evaluation. The vaginal tactile imager assists in evaluation of the changes in the pelvic floor after physiotherapy.

NCT ID: NCT03566290 Withdrawn - Clinical trials for Stress Urinary Incontinence

Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence

Start date: June 28, 2018
Phase: Phase 2
Study type: Interventional

This open-label extension study, for subjects from the G201002 study, will provide additional long-term safety and tolerability data for GTx-024. All subjects in this study will receive GTx-024 3 mg orally, once daily.

NCT ID: NCT03508648 Withdrawn - Clinical trials for Stress Urinary Incontinence

Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence

Start date: May 28, 2018
Phase: Phase 2
Study type: Interventional

The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.

NCT ID: NCT02524366 Withdrawn - Clinical trials for Stress Urinary Incontinence

A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement

Start date: September 2015
Phase: N/A
Study type: Interventional

We propose a randomized non-blinded comparison of standard vs. transcorporal approach for placement of an artificial urinary sphincter in male patients with stress urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the United States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff, which is the portion of the device that encircles and occludes the urethra, is typically placed directly around the urethra (i.e., "standard" placement). The cuff can erode into the urethra. Transcorporal placement has been introduced as a method to reduce the risk of erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so as to protect the dorsal aspect of the urethra. This approach has never been compared to standard placement in a randomized fashion. In our randomized trial, no additional procedures beyond the normal care protocol will be required of the patients. We will conduct the study through our established, IRB-approved multi-institutional network of surgeons. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.

NCT ID: NCT01763957 Withdrawn - Quality of Life Clinical Trials

Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence

Start date: March 2013
Phase: N/A
Study type: Interventional

The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.

NCT ID: NCT01379378 Withdrawn - Prostate Cancer Clinical Trials

Male Stress Urinary Incontinence and Sexual Health

Start date: October 2011
Phase: N/A
Study type: Observational

The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.