Clinical trials: Pelvic Floor Disorders
Interstitial Cystitis, Chronic Pain
A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain Management
The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat pelvic floor muscle overactivity that complicates…
- Conditions
- Interstitial Cystitis, Chronic Pain, Pelvic Floor; Relaxation, Pelvic Floor Disorders
- Trial name
- NCT05062902
- Testing
- High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device, Botulinum Neurotoxin
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- HillMed Inc.
Pelvic Floor Disorders
Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound
Subjects will place a surface electrode on their perineal area after a bladder-filling protocol. Transabdominal ultrasound will image the base of the bladder at rest, voluntary pelvic floor contraction, with the surface…
- Trial name
- NCT03528928
- Testing
- Surface electrical stimulation
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Elidah, Inc.
Urinary Incontinence, Pelvic Floor Disorders
Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Pelvic Static Disorders in Women With Urinary Incontinence.
The goal of this clinical trial is to evaluate the short-term improvement in urinary incontinence after perineo-sphincter rehabilitation using functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) in…
- Trial name
- IncontiLib (NCT05938855)
- Testing
- Electrical stimulation and biofeedback with the medical device Phenix Liberty
- Where
- 2 sites in France
- Volunteers
- 30 people
- Sponsor
- Vivaltis
Pelvic Floor Disorders, Pelvic Pain
Digital Care Programs for Female Pelvic Health
The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs.
- Conditions
- Pelvic Floor Disorders, Pelvic Pain, Pelvic Organ Prolapse, Pelvic Floor Muscle Weakness
- Trial name
- NCT05513417
- Testing
- Bloom Pod
- Where
- United States
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Sword Health, SA
Pelvic Organ Prolapse
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement
- Trial name
- CASPO (NCT03821142)
- Testing
- Transvaginal mesh for anterior pelvic organ prolapse repair
- Where
- 6 sites in Germany
- Volunteers
- 180 people
- Sponsor
- Promedon
Childbirth
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device.
- Trial name
- NCT06698185
- Testing
- Materna Prep Device
- Where
- United States
- Sponsor
- Materna Medical
Stress Urinary Incontinence, Pelvic Floor Disorders
Comparison of Virtual Pelvic Floor Physical Therapy With a Pelvic Floor Trainer in the Treatment of Stress Urinary Incontinence.
The goal of this clinical trial is to compare the efficacy of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence to treatment with pelvic floor physical…
- Trial name
- NCT06097234
- Testing
- Pelex Upp, Pelvic Floor Physical Therapy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Pelex
Pelvic Floor Disorders
Combination Treatment With BTL-899 and HPM-6000UF Devices
This study will evaluate the clinical efficacy of the BTL-899 and HPM-6000UF devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in elderly patients.
- Trial name
- NCT05537181
- Testing
- BTL-899; HPM-6000UF Treatments
- Where
- 3 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
Stress Urinary Incontinence, Urinary Incontinence
Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence
The goal of this clinical trial is to assess the efficacy and usability of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence, Pelvic Floor Disorders
- Trial name
- NCT05624645
- Testing
- Pelex Upp
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Pelex
Pelvic Organ Prolapse
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle.
- Trial name
- NCT02162615
- Testing
- Restorelle Direct Fix A, Restorelle Direct Fix P, Native Tissue Repair Anterior
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 810 people
- Sponsor
- Coloplast A/S
Overactive Bladder, Urge Incontinence
Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study
This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.
- Conditions
- Overactive Bladder, Urge Incontinence, Pelvic Floor Disorders
- Trial name
- MOTIVATION (NCT04853849)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Renalis
Pelvic Floor Disorders
Laparoscopic Tactile Imaging in Urogynecologic Surgery
During laparoscopic surgery, video camera becomes a surgeon's eyes since the surgeon uses image from the video camera positioned inside the patient's body to perform the procedure.
- Trial name
- LTI (NCT03164850)
- Testing
- Laparoscopic Tactile Imaging
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Pelvic Organ Prolapse
Exair® Versus Native Tissue Repair for Prolapse
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
- Trial name
- NCT02162628
- Testing
- Exair Prolapse Repair System, Total Native Tissue Repair
- Where
- 14 sites in United States, Canada
- Volunteers
- 79 people
- Sponsor
- Coloplast A/S