Ongoing Clinical Trials for Urinary Incontinence
Currently, there are 4 ongoing clinical trials exploring different treatments for urinary incontinence. These studies include research on medication therapies for children with overactive bladder, hormone treatments for postmenopausal women with vaginal atrophy, and innovative stem cell therapy for men after prostate surgery.
Clinical trial locations
- Denmark
- Study on Solifenacin, Mirabegron, and Their Combination for Treating Overactive Bladder and Daytime Urinary Incontinence in Children Aged 5 to 14 Years
- Study on Stopping Solifenacin and Mirabegron for Children with Daytime Urinary Incontinence
- Study on the Effects of Vaginal Estrogen Treatment with Nomegestrol Acetate and Estradiol Hemihydrate on Blood Clotting in Postmenopausal Women with Vaginal Atrophy
- Poland
Study on Solifenacin, Mirabegron, and Their Combination for Treating Overactive Bladder and Daytime Urinary Incontinence in Children Aged 5 to 14 Years
This trial is examining treatments for children between 5 and 14 years old who experience overactive bladder and daytime incontinence. The study investigates three different medication approaches: solifenacin, which helps relax bladder muscles; mirabegron, which helps the bladder hold more urine; and a combination of both medications.
Main inclusion criteria: Children must be between 5 and 14 years old and have at least 2 episodes of daytime incontinence per week. They should have tried non-drug treatment (urotherapy) for at least 4 weeks without sufficient improvement. Children must not have been previously treated with these specific medications or botulinum toxin injections. They should not currently have constipation or fecal incontinence, though laxative use is permitted. The child must be able to swallow or learn to swallow the study medication.
Main exclusion criteria: Children younger than 5 or older than 14 years cannot participate. Those without daytime incontinence or overactive bladder are not eligible.
Focus of the trial: The primary goal is to evaluate how effectively these treatments reduce the number of wet days per week over a 12-week treatment period. The study will also monitor changes in incontinence severity, urge severity, and bladder function metrics over 18 weeks. Regular monitoring for any side effects will occur throughout the study.
Investigational drugs: The trial is testing solifenacin (an antimuscarinic agent), mirabegron (a beta-3 adrenergic agonist), and their combination therapy to determine the most effective treatment approach for children with these bladder control issues.
Study on Stopping Solifenacin and Mirabegron for Children with Daytime Urinary Incontinence
This trial focuses on children who have successfully achieved bladder control using solifenacin and/or mirabegron and examines what happens when these medications are stopped. The study compares stopping medication suddenly versus gradually reducing the dosage.
Main inclusion criteria: Children must be between 5 and 14 years old and have been diagnosed with daytime incontinence according to specific medical guidelines. They must be currently receiving treatment with solifenacin and/or mirabegron and have achieved bladder control while on these medications. Children must have maintained control on the same dose for at least three months. Previous attempts to stop medication are allowed.
Main exclusion criteria: Patients not experiencing daytime incontinence or those outside the specified age range cannot participate.
Focus of the trial: The study aims to determine whether the method of stopping medication (abrupt or gradual) affects the likelihood of incontinence returning. Participants will be monitored for up to 12 months to track any recurrence of incontinence using a 14-day calendar. The study will also assess withdrawal symptoms using a questionnaire up to 44 days after withdrawal begins.
Investigational drugs: The trial examines solifenacin and mirabegron, both medications that have been successfully used to manage bladder control, to understand the best approach for discontinuing treatment without symptom recurrence.
Study on the Effects of Vaginal Estrogen Treatment with Nomegestrol Acetate and Estradiol Hemihydrate on Blood Clotting in Postmenopausal Women with Vaginal Atrophy
This trial studies the effects of local vaginal estrogen treatment in postmenopausal women who experience vaginal atrophy, a condition where vaginal tissues become thin, dry, and inflamed due to decreased estrogen levels. The treatment combines nomegestrol acetate and estradiol hemihydrate.
Main inclusion criteria: Participants must be postmenopausal women aged 50 or older who have not had menstrual periods for at least 12 months. They must experience symptoms of vaginal atrophy such as dryness, irritation, or discomfort. Women must have a medical need for standard treatment with vaginal estrogen (10 micrograms at least three times per week). Participants can have had or not had a previous history of venous thromboembolism.
Main exclusion criteria: Men and women who are not postmenopausal cannot participate. Those considered part of vulnerable populations are also excluded.
Focus of the trial: The study examines how vaginal estrogen treatment affects blood clotting and breakdown processes in the body over three months. This is important because changes in these processes can affect the risk of blood clots. Researchers will monitor blood parameters to determine if the treatment has any significant effects on hemostatic balance.
Investigational drugs: Local vaginal estrogen is administered as a cream, tablet, or ring directly to the vaginal area. It works by binding to estrogen receptors in vaginal tissue, promoting growth and maintenance of the vaginal lining to relieve symptoms like dryness and discomfort.
Study on the Effectiveness and Safety of Stem Cell Therapy for Urinary Incontinence in Patients After Prostate Surgery
This trial evaluates an innovative treatment for men who experience incontinence after undergoing radical prostatectomy (surgical removal of the prostate gland). The treatment uses stem cells taken from the patient’s own fat tissue.
Main inclusion criteria: Participants must be males over 18 years old who have undergone robot-assisted radical prostatectomy. They must have Grade 2 stress incontinence, confirmed by a 24-hour pad test showing total daily pad weight between 100-400 grams and verified by urodynamic studies. The prostate cancer must have been at specific stages after surgery. Patients must have a BMI greater than 20 kg/m² with sufficient abdominal and buttock fat for liposuction. They must test negative for HIV, hepatitis B and C, and syphilis.
Main exclusion criteria: Only males can participate. Individuals considered part of vulnerable populations are not eligible.
Focus of the trial: The study compares injections of autologous adipose-derived mesenchymal stem cells (called ATIMP) to a placebo. The stem cells are injected into the urethral sphincter complex, the muscle that helps control urine release. The main goal is to assess whether this treatment can reduce urine leakage by at least 50% and improve bladder function. The trial is double-blind to ensure unbiased results, and participants will be monitored for several years for effectiveness and safety.
Investigational drugs: ATIMP is a somatic cell-based therapy involving stem cells from the patient’s own fat tissue. These cells are expanded in a laboratory and injected back into the body to potentially regenerate or repair the urethral sphincter tissue, improving urinary control.
Summary
The four ongoing clinical trials for urinary incontinence represent diverse approaches to treating different patient populations. Three of the trials are taking place in Denmark, focusing on pediatric patients with overactive bladder and postmenopausal women with vaginal atrophy. One trial is being conducted in Poland, targeting men who have undergone prostate surgery.
A notable observation is the concentration of research on pediatric incontinence, with two Danish trials examining both the effectiveness of medications (solifenacin and mirabegron) and the best approach for discontinuing these treatments. The Polish trial represents an innovative approach using regenerative medicine through stem cell therapy, which may offer new hope for post-surgical incontinence in men. The Danish trial on vaginal estrogen explores an important aspect of postmenopausal health while carefully monitoring blood clotting effects for safety.
These trials collectively address incontinence across different ages, genders, and underlying causes, reflecting the complex nature of this condition and the need for tailored treatment approaches.
