Clinical Research Directory

Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction

The goal of this clinical trial is to learn whether capacitive-resistive radiofrequency, a supervised core and pelvic floor exercise programme, or both together reduce low back pain in premenopausal women with chronic non-specific low back pain and pelvic floor dysfunction. The main question it aims to answer is: do the three treatments differ in lumbar pain intensity (0-10 visual analogue scale) 1 week after the treatment ends? Researchers will also compare pain quality, low back disability, pelvic floor symptoms, urinary incontinence, pelvic floor muscle function and lumbar mobility up to 3 months after treatment. Sixty women will be randomly assigned to one of three groups: * Radiofrequency: nine weekly 20-minute sessions applied to the lower back and, through a vaginal electrode, to the pelvic floor. * Exercise: a 12-week programme of supervised group sessions (three 30-minute sessions per week) for the core and pelvic floor muscles. * Combined: both treatments at the same time. Participants will complete questionnaires and a physical examination before treatment and 1 week, 1 month and 3 months after treatment ends.

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).

Quantity of Bulkamid® After Injection for Urinary Incontinence

Bulkamid filler is a gel that we use very regularly to treat female urinary leakage during exercise. It is a minimally invasive technique which is increasingly used around the world because it has almost no adverse effects compared to suburethral slings. The product is injected pre-urethrally and under local anesthesia. The results in terms of improvement are around 70% without knowing why certain patients are improved, slightly improved or not improved at all. One of the hypotheses is that a proportion of the product could be eliminated, and thus the mechanical effect would be reduced. Perineal ultrasound performed in routine practice allows the quantity of gel to be measured in 3 dimensions immediately post-operatively and at 3 months. The objective of this study is to compare the volume of gel between the immediate post-operative and 3 months and to correlate it with clinical results of improvement.

Perineal Ultrasound After Bulkamid® Injection for Urinary Incontinence

There are currently different treatment options in the management of stress urinary incontinence (SUI). Given a risk of complications inherent to prosthetic reinforcement and numerous current controversies over the use of a synthetic material, other alternatives must be offered to patients. Peri-urethral injections of filler are increasingly becoming part of the therapeutic arsenal. This is a minimally invasive technique carried out under local anesthesia on an outpatient basis. Peri-urethral injections are currently offered to all patients with stress urinary incontinence, due to sphincter or mixed insufficiency and particularly after suburethral sling failure. Perineal ultrasound after injection allows you to visualize the positioning of the filler bubbles under the bladder neck. In the event of clinical ineffectiveness associated with poor position of the bubbles, this could be an argument for a 2nd injection. If, on the contrary, the bubbles are well positioned, another technique could be proposed.

Augmenting Urinary Reflex Activity: Study 3

AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.

Tolerance, Use and Performance of the PEASY Urine Collection Device in Hospitalized Patients

At present, 3 types of urine collection device can be distinguished: absorbent devices (diaper-type), penile clamps and penile collection sheaths. Both pads and penile sheaths are used depending on the department concerned, the clinical context and user preferences. A 2023 survey at Nîmes University Hospital showed that penis sleeves have undesirable side effects like fixation problems and pain on removal, and care assistants reported penile irritation caused by the penis sleeve. Caregivers also reported difficulties when handling and using penis sleeves. There is clearly a need for a better device.To overcome the disadvantages of penis covers, the PEASY project team at Nîmes University Hospital has developed a practical, non-invasive medical device for eliminating urine, positioned on the glans: the PEASY device. This device is held in place by a non-adhesive fastening system that involves the foreskin, to ensure leakage-free urine flow.

Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.

This randomized, parallel-group, non-inferiority clinical trial will compare electromagnetic chair therapy with standard electrostimulation combined with biofeedback in 58 adult women with mixed urinary incontinence. Participants will be randomized 1:1 to receive 12 treatment sessions over six weeks. Clinical outcomes will be assessed at baseline, at the end of treatment (week 6), and at week 30. The primary endpoint is the change from baseline to week 6 in the average daily number of total urinary incontinence episodes, recorded in a three-day bladder diary. Secondary outcomes include changes in urgency and stress urinary incontinence episodes, voiding frequency, nocturia, pad use, ICIQ-UI SF scores, patient-reported improvement, responder rates, and urodynamic parameters. Safety and treatment adherence will also be evaluated throughout the study.

BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women

The goal of this clinical trial is to evaluate if the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices is able to improve depressive symptoms and sexual function in women who are perimenopausal or postmenopausal without an alternative medical cause before enrollment in the study and are aged 40 years and older. The main question it aims to answer is: Does the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices improve depressive symptoms and urinary incontinence? Participants will be asked to: Undergo twelve treatments Complete the Patient Health Questionnaire-9 Complete the 6-item Hamilton Depression Rating Scale Complete the Greene Climacteric Scale Complete the Therapy Comfort Questionnaire Complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Complete the Female Sexual Function Index Complete the Warwick-Edinburgh Mental Wellbeing Scale Complete the Columbia Suicide Severity Rating Scale-Screen version Complete the Subject Satisfaction Questionnaire Complete the Therapy Comfort Questionnaire

This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.

This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.

Synthetic Versus Autologous Sling For Stress Incontinence

This is a multi-centre randomized controlled trial comparing mid-urethral synthetic mesh sling or tension-free vaginal tape (TVT) and autologous fascia sling (AFS) in elderly patients with stress predominant urinary incontinence. The investigators aim to investigate new onset pelvic pain 6 months post-op and objective urinary incontinence cure rate 5 years post-op. Secondary objectives include investigation of opioid use, mental health, sexual health, and other post-op outcomes.

Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms

The objective of our multi-center randomized single-blind study is to examine the safety and effect of intra-detrusor OnabotulinumtoxinA injections at the time of holium laser enucleation of the prostate (HoLEP) in men with overactive bladder symptoms with and without urge incontinence.

Implementing a Mobile Health Application for Women Veterans With Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0

Implementing a Mobile Health Application for Women Veterans with Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effects of the Evidence-Based Program (EBP) in its new context and focusing on equitable reach (extent to which the program serves all members of its intended audience). The overall goal is to implement, evaluate, and sustain MyHealtheBladder in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.

Pelvic Floor Muscle Training During Pregnancy

The project seeks to investigate effectiveness of PFMT during pregnancy.

Male Pelvic Floor Muscle Rehabilitation Exercises

Phase I G128 Study Objective The ischiocavernosus (IC) and bulbospongiosus (BS) muscles are vital components of the superficial perineal layer, serving as the foundation for male sexual health and performance. These muscles play a primary role in achieving and maintaining erections by compressing the veins to trap blood within the erectile tissues. Furthermore, they are responsible for the rhythmic contractions necessary for ejaculation and the physiological sensations associated with orgasm. Beyond their role in sexual function, these muscles provide critical structural support to the pelvic floor and assist in urinary control. By working in tandem, the IC and BS muscles ensure penile rigidity while stabilizing the surrounding pelvic structures. Maintaining the strength and coordination of these muscles is essential for overall reproductive health and the prevention of pelvic floor dysfunction. The primary objective of this clinical trial is to evaluate the clinical efficacy and therapeutic potential of Exercise G128 in strengthening the male pelvic floor musculature. Furthermore, the study aims to establish a comprehensive safety profile for Exercise G128 during active participation. The research seeks to address the following core investigative questions: To what extent does Exercise G128 improve the tonicity and contractile strength of the IC and BS muscles? What is the incidence and nature of adverse medical events or physiological stressors reported by participants while performing the Exercise G128 protocol? Researchers will conduct a comparative analysis, benchmarking the physiological outcomes of Exercise G128 against existing clinical data regarding the efficacy of traditional Kegel exercises. Participant Requirements: Adhere to a structured regimen, performing Exercise G128 four times weekly over a one-month intervention period. Attend bi-weekly telehealth consultations via video conferencing for supervised clinical assessments, progress monitoring, and physiological testing. Maintain a detailed daily log documenting functional progress, as well as any instances of physical exertion or soreness that necessitated a temporary cessation of the exercise protocol. UPDATE: The G128 inventor and user scheduled an appointment with a Certified Pelvic Rehab Practitioner, who has over 10 years of experience treating complex diagnoses and pelvic impairments. During the appointment, a male pelvic floor muscle test was performed using Rehabilitative Ultrasound Imaging (RUSI). Ultrasound Findings (suprapubic RUSI): Muscle bulk is visually above average compared to clinician's clinical experience; good bilateral muscle mass noted with asymmetry as described. Voluntary Contraction / Coordination: Patient demonstrated visible pelvic floor lift on ultrasound with volitional kegel contraction. Contraction quality: good lift observed; clinician noted contraction quality as above average relative to clinical experience.

Adjustable Continence Therapy (ACT) for the Treatment of Female SUI

A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.

The Effect of Health Belief Model-Based Pelvic Floor Muscle Exercise Training on Urinary Incontinence and Quality of Life in Female Patients With Multiple Sclerosis

The aim of this study is to evaluate the effect of Pelvic Floor Muscle Exercise Training According to the Health Belief Model on Urinary Incontinence and Quality of Life in Female Patients with Multiple Sclerosis. Hypothesis 01: Pelvic floor muscle exercise training applied using the health belief model is not effective in reducing urinary complaints in female MS patients. Hypothesis 1: Pelvic floor muscle exercise training applied using the health belief model is effective in reducing urinary complaints in female MS patients. Hypothesis 02: Pelvic floor muscle exercise training applied using the health belief model is not effective on the quality of life of female MS patients. Hypothesis 2: Pelvic floor muscle exercise training applied using the health belief model is effective on the quality of life of female MS patients.

Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy

This randomized controlled trial investigates the effects of hypopressive exercises on urinary incontinence and erectile dysfunction in men following radical prostatectomy. Participants will be randomly assigned to one of two groups: a control group receiving home-based pelvic floor muscle exercises and an experimental group receiving both pelvic floor muscle exercises and supervised hypopressive exercises twice per week. The study aims to determine whether the addition of hypopressive techniques, which target coordinated activation of the pelvic floor and abdominal muscles without increasing intra-abdominal pressure, offers greater improvements in urinary and sexual function. Primary outcomes include pelvic floor muscle strength and endurance, while secondary outcomes include urinary incontinence severity, erectile function, and quality of life.

Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy

Urinary incontinence is a common complication following prostatectomy and affects a substantial proportion of patients. Despite advances in surgical technique, many patients experience persistent symptoms that negatively impact quality of life. Current management strategies include pelvic floor muscle training, biofeedback and physical therapy, and surgical options. However, these approaches may be limited by adherence, access, and invasiveness, leaving a subset of patients with ongoing symptoms despite standard care. Non-invasive pelvic floor neuromuscular stimulation has emerged as a potential adjunct for pelvic floor rehabilitation by inducing supramaximal muscle contractions and enhancing neuromuscular activation without requiring active patient effort. Preliminary studies suggest that high-intensity electromagnetic stimulation may improve patient-reported continence outcomes and pad usage in women as well as men following radical prostatectomy, though existing data are limited by small sample sizes and short follow-up durations. Additionally, no clinical studies exist evaluating outcomes in men following prostatectomy prior to established stress incontinence. Given these limitations, further evaluation is needed to assess the feasibility, tolerability, and short-term effectiveness of this intervention in a post-prostatectomy population.

Pelvic Floor Rehabilitation Programme for Women With Urinary Incontinence in a Peruvian Public Hospital

This study evaluates whether a 12-week pelvic floor rehabilitation programme improves urinary incontinence symptoms in adult women treated at Hospital Nacional Edgardo Rebagliati Martins, a public tertiary hospital in Lima, Peru. Women referred by the Urology Service attend supervised group pelvic floor muscle training with a physiotherapist, together with individual sessions with a physiatrist that may include EMG biofeedback, electrical stimulation, transcutaneous tibial nerve stimulation, myofascial techniques or bladder training. The main question is whether symptom severity, measured with the ICIQ-SF questionnaire, improves between baseline and week 12. Participants are followed for 6 months.

Effects of a Multimodal and Multidimensional Intervention on Urinary Incontinence in Young Nulliparous Female Athletes.

A prevalence of urinary incontinence ranging from 5.7% to 80% has been observed in young nulliparous athletes during their activity. The usual recommendations for managing adult women do not seem to be transferable. Young nulliparous athletes need specific educational and behavioral interventions and an alternative to pelvic floor muscle strengthening. A multimodal and multidimensional intervention for athletes and coaches combining specific pelvic health education and strengthening of lumbopelvic-abdominal stability appears to be an innovative and optimal solution for reducing the symptoms of urinary incontinence in young nulliparous women who participate in athletics.

Trial of NASHA Dx Urethral Bulking System

Prospective, randomized, single-blind study to evaluate the safety and efficacy of NASHA Dx investigational device compared to controlled device Bulkamid in adult women with mild, moderate and intrinsic sphincter deficiency (ISD).

Effect of Music and Lighting on Anxiety During Urodynamic Study

This study is designed to evaluate the effects of environmental modifications, specifically music and lighting conditions, on anxiety in patients undergoing urodynamic study (UDS). Approximately 220 adult participants are planned to be randomly assigned to one of four intervention groups. Anxiety levels before and after the procedure will be assessed using the State-Trait Anxiety Inventory (STAI). The study aims to determine the independent and combined effects of music and lighting on patient anxiety during UDS.

Effects of Spinal Stabilization on the Pelvic Floor in Women With Multiple Sclerosis

The purpose of this study was to investigate the effects of spinal stabilization exercises focusing on the pelvic floor on core stability, urinary symptoms and pelvic floor muscle function in women with Multiple Sclerosis and lower urinary tract symptoms. Participants will be randomly assigned to a control group that receives pelvic floor muscle exercises only or an experimental group that receives both pelvic floor muscle exercises and spinal stabilization exercise focused on the pelvic floor. Outcome measures will be assessed pre- and post-intervention using validated instruments.

Physiotherapy Management in Women With Urinary Incontinence

Main objective: The primary aim of the study is to assess whether the author's exercise programme has an effect on reducing urinary incontinence and pelvic floor dysfunction after childbirth, considering vacuum extractor, forceps and caesarean section deliveries. Secondary objective: The secondary objective is to determine whether the duration of the author's exercise programme is sufficient to achieve positive changes in women.