Clinical Research Directory

Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy

Advice on how long to limit physical activity after pelvic floor surgery ranges from 2 to 12 weeks and rests mainly on local tradition rather than data. This prospective observational study follows women undergoing a retropubic midurethral sling (TVT) for stress urinary incontinence or a laparoscopic sacrocolpopexy for pelvic organ prolapse at a single centre in Poland. For 6 weeks after surgery, participants keep a weekly diary of ten everyday activities, pain, and the reasons for not resuming each activity, and they complete validated questionnaires up to 6 months. The study does not change any aspect of treatment. Its main aim is to estimate the time to return to the pre-operative level of physical activity in each cohort.

Prophylactic Antibiotics for Outpatient Urethral Bulking

The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).

Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires.

Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study

The goal of this randomized pilot study is to determine whether adding expiratory muscle strength training (EMST) to standard pelvic floor muscle training (PFMT) is feasible and may help improve stress urinary incontinence (SUI) in females assigned at birth, ages 18 to 79. SUI is urine leakage that occurs during activities such as coughing, sneezing, laughing, or exercising. The main questions this study aims to answer are: Can participants complete the combined exercise program, and is it acceptable to them? Does adding EMST to PFMT lead to greater improvements in urinary leakage symptoms and participants' perceived improvement compared with PFMT alone? Does adding EMST improve breathing muscle strength and pelvic floor muscle activity? Researchers will enroll 24 participants and randomly assign them to one of two groups: Group 1: Standard physical therapy, including pelvic floor muscle training. Group 2: The same physical therapy and pelvic floor muscle training, with the addition of expiratory muscle strength training. Both groups will receive six weeks of supervised physical therapy, with one session each week. Participants will attend seven study visits over approximately seven weeks, including an initial assessment and six treatment visits. Participants will: Complete questionnaires about urinary leakage symptoms and perceived improvement. Have their breathing muscle strength measured using a test that measures how strongly they can breathe out. Have pelvic floor muscle activity measured using a surface electromyography (sEMG) sensor. Perform prescribed home exercises and record their exercise completion in a log. Participants in both groups will practice pelvic floor muscle exercises at home. Participants in the combined-treatment group will also use a device that provides resistance when breathing out. They will perform five sets of five breaths daily, with resistance based on their measured breathing muscle strength. Researchers will assess whether participants complete the study visits, follow the home exercise program, complete the study measures, and report satisfaction with the program. They will also monitor any unwanted effects related to the exercises or assessments. The study will explore whether adding EMST to PFMT may improve urinary leakage symptoms, breathing muscle strength, and pelvic floor muscle activity. Participants may experience improvements, but benefits are not guaranteed. The results will help researchers determine whether a larger study is needed to better evaluate this combined treatment for stress urinary incontinence.

Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate

Holmium laser enucleation of the prostate (HoLEP) is an effective operation for men with urinary obstruction caused by a benign enlarged prostate. Some men leak urine for a period after the operation. Early apical release is a surgical step that frees the tip (apex) of the prostate at the start of the operation to reduce stretch on the urinary sphincter. The conventional technique cuts all the way around the apex, including the front (anterior) tissue next to the sphincter. This randomized trial compares a modified technique, Anterior Bridge-Preserving Semicircular Early Apical Release (ABP-S-EAR), with conventional early apical release during HoLEP. ABP-S-EAR leaves the front tissue bridge between the 11 and 1 o'clock positions intact. Men aged 45 to 80 years scheduled for HoLEP at Benha University Hospital, Egypt, will be randomly assigned to one technique. The main question is whether ABP-S-EAR improves urinary continence 1 month after surgery. The trial also compares continence at 3, 6, and 12 months, operative time, bleeding, catheter time, hospital stay, urinary symptoms, urine flow, and complications.

Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Second-generation Radiofrequency Application and Therapeutic Exercise for Stress Urinary Incontinence

Stress urinary incontinence (SUI) is defined as the loss of the ability to hold urine after exertion, i.e., as a result of imbalances in intra-abdominal pressure, which directly affect the lower urinary tract. SUI has been shown to have a significant impact on the quality of life of those affected, impacting physical, social, and psycho-emotional aspects. Among the proposed treatments is a physiotherapeutic approach, which is offered as a less invasive and painless therapy with fewer adverse effects than pharmacological or surgical treatment. Pelvic floor muscle training (PFMT) is the most effective physiotherapeutic treatment for SUI, increasing the contractile capacity of the muscles and restoring stability throughout the pelvic diaphragm, thereby ensuring proper support of the pelvic organs. Radiofrequency (RF) therapy is currently being proposed as a therapeutic option that may offer certain advantages over those reported for photoplethysmography (PPMT). The potential benefits of RF therapy are attributed to its ability to stimulate collagen metabolism, thereby promoting tissue regeneration. Radiofrequency (RF) is a non-invasive and painless method that has the potential to yield analogous results to pelvic physical therapy (PPMT) as a standalone treatment or enhance the efficacy of PPMT when administered in conjunction with RF for stress urinary incontinence (SUI). The objective of the present study is to analyse the effectiveness of PFMT and RF as single or combined treatments for SUI in women at Clínica Traña, a clinic specialising in the treatment of pelvic floor dysfunction in Costa Rica. Following the process of obtaining informed consent, patients will be offered a single or combined treatment of RF and/or PFMT. The strength of the pelvic floor muscles, pelvic function and the impact of pelvic dysfunctions on quality of life will be evaluated with a one-year follow-up after the conclusion of treatment. The project possesses the facilities, equipment, and personnel necessary to ensure its viability, as well as proven clinical experience. The scientific and technical impact of the proposed treatment protocol will be achieved by establishing an effective therapeutic strategy to address SUI. The social impact of SUI is significant, given its high prevalence and the fact that it has physical consequences as well as a negative impact on the social activities, work functions and emotions of women who suffer from it.

CREDE Study: Intraoperative Crede Manoeuver Compared to Preoperative Prolapse Reduction Stress Test to Predict Postoperative de Novo Stress Urinary Incontinence (PONSUI) at the Time of Pelvic Organ Prolapse (POP) Surgery

The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress test (M2) for the prediction and prevention of PONSUI. The rates of PONSUI and its effect on patient reported outcomes and quality of life will be determined among women with positive or negative tests, and those with and without concomitant anti-incontinence procedure performed. This information will help inform larger studies on the topic.

Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)

The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).

Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial

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.

ProACT Post-Approval Study

The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.

Pessary Experience Study

Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.

Effectiveness of an 8-week Independent Cadence Retraining Program on Stress Urinary Incontinence in Parous Runners.

The purpose of this research is to assess the impact of an eight-week home cadence training program on stress urinary incontinence symptoms in parous women.

The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence

FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population.

Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence

his prospective interventional study will evaluate the effectiveness and safety of peri-urethral injections of platelet-rich plasma for treating stress urinary incontinence in postmenopausal women. Platelet-rich plasma is prepared from each participant's own blood and contains concentrated platelets and growth factors that may promote tissue repair and regeneration. Approximately 70 postmenopausal women with stress urinary incontinence will receive peri-urethral platelet-rich plasma injections once monthly for four consecutive months. Platelet-rich plasma will be injected into five sites around the urethra. Participants will be followed after treatment to assess improvement in urinary leakage and urinary symptoms, changes in urodynamic measurements, and treatment-related adverse events. The study aims to determine whether repeated peri-urethral platelet-rich plasma injections can provide a safe and effective minimally invasive treatment option for postmenopausal women with stress urinary incontinence.

Magnetic Stimulation as a Treatment for Female Urinary Incontinence

The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with urinary incontinence.

Tactile Feedback Pelvic Floor Training to Prevent Stress Urinary Incontinence in the 3rd Trimester of Pregnancy

Pregnancy involves significant physiological changes, such as hormone fluctuations, weight gain, and fetal growth, which can affect multiple organ systems. These changes often lead to symptoms like stress urinary incontinence (SUI) and may worsen existing conditions. SUI affects about one-third of pregnant women and can decrease quality of life. Pelvic floor muscle exercise (PFME) is a recommended treatment to manage urinary incontinence during pregnancy and postpartum. This study aims to compare the effectiveness of three interventions: routine health education, traditional PFME, and tactile feedback PFME, on reducing SUI symptoms, shortening the second stage of labor, and improving quality of life. Participants will be enrolled in their third trimester and randomly assigned to one of the three groups, with each intervention lasting 8 weeks. Outcome measures include urinary symptoms (via bladder diary, UDI-6, and IIQ-7), quality of life (via KHQ and WHOQOL-BREF), and labor outcomes (duration of the second stage).

Laser Therapy for Treatment of Urogenital Symptoms in Women

This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.

Desara ® One Single Incision Sling 522 Study

A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.

MoVo-guided Traditional Chinese Kegel Exercises for Preventing Postpartum Urinary Incontinence.

The goal of this clinical trial is to determine whether a prenatal exercise program integrating Liuzijue qigong with traditional levator ani training, guided by the MoVo (Motivation-Volition) theory and delivered via a supervised mobile application, can effectively prevent postpartum urinary incontinence and pelvic organ prolapse in pregnant women, compared with app-supervised conventional Kegel exercises and routine prenatal care. The main questions it aims to answer are: Does the integrated Liuzijue-and-levator-ani program reduce the incidence of postpartum urinary incontinence and prolapse more effectively than app-supervised Kegel exercises or routine care? Can the MoVo-based behavioural framework (motivation enhancement, action planning, and self-monitoring) improve long-term adherence to pelvic floor training during pregnancy and the postpartum period? What are the effects of the three interventions on pelvic floor muscle function, exercise self-efficacy, anxiety levels, and delivery outcomes? Researchers will compare three parallel groups: (1) the integrated Liuzijue-and-levator-ani exercise group, (2) the app-supervised conventional Kegel exercise group, and (3) the routine care control group receiving only verbal instruction on pelvic floor exercises during standard prenatal visits. All three groups will be followed from enrolment through 6 weeks postpartum to determine whether the culturally adapted mind-body intervention offers superior pelvic floor protection beyond app-delivered Kegel training and routine care. Participants will: Be enrolled in the third trimester and randomly assigned to one of the three groups. In the integrated exercise group, perform daily combined Liuzijue-and-levator-ani exercises via a supervised mobile app and attend periodic check-ins until 6 weeks postpartum. In the app-supervised Kegel group, perform daily conventional Kegel exercises via the same mobile app platform with the same supervision schedule. In the routine care group, receive only standard verbal instructions on Kegel exercises during regular antenatal check-ups, without app supervision. Undergo outcome evaluations at enrolment, before delivery, and at the postpartum follow-up visit, including assessments of urinary incontinence, pelvic organ prolapse, exercise adherence, self-efficacy, anxiety, and any adverse events.

Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.

Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.

BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence

Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.

Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).