Clinical trials: Pelvic Floor Disorders
Stress Urinary Incontinence, Mixed Urinary Incontinence
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using…
- Trial name
- NCT03632447
- Testing
- Leva, PFDx
- Where
- 7 sites in United States
- Volunteers
- 77 people
- Sponsor
- Renovia, Inc.
Muscle Weakness
Combination Treatment With BTL-899 and HPM-6000UF Devices II
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 female patients after childbirth.
- Trial name
- NCT05713864
- Testing
- BTL-899, HPM-6000UF
- Where
- 3 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
Pelvic Organ Prolapse (POP)
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.
- Trial name
- (A&P) (NCT01378065)
- Testing
- Restorelle Direct Fix A&P
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
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.
Urinary Incontinence
rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence.
- Trial name
- NCT03969368
- Testing
- rPMS device, Pelvic floor muscle training
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- BTL Industries Ltd.
Urinary Incontinence, Urinary Incontinence (UI)
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).
- Conditions
- Urinary Incontinence, Urinary Incontinence (UI), Urinary Incontinence , Stress, Urinary Incontinence Due to Urethral Sphincter Incompetence
- Trial name
- NASHA-DX (NCT07850804)
- Testing
- NASHA Dx, Bulkamid
- Where
- 5 sites in United States
- Volunteers
- 314 people
- Sponsor
- Palette Life Sciences, 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.
Pelvic Organ Prolapse
ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse.
- Trial name
- NCT02021279
- Testing
- MatriStem Pelvic Floor Matrix, native tissue repair
- Where
- 13 sites in United States
- Volunteers
- 161 people
- Sponsor
- Integra LifeSciences Corporation
Urinary Incontinence,Stress, Urinary Incontinence, Urge
RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application
This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health…
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Urinary Incontinence, Overactive Bladder Syndrome
- Trial name
- DINKS (NCT06389838)
- Testing
- Kranus Mictera
- Where
- Germany
- Volunteers
- 194 people
- Sponsor
- Kranus Health GmbH
Stress Urinary Incontinence, Sexual Dysfunction
Effectiveness of Kegel Exercise Device in Strengthening Pelvic Floor and Treating Urinary Incontinence (UI)
This study will assess the effectiveness of a new pelvic floor exercise device in strengthening pelvic floor muscles and treating urinary incontinence among women who are experiencing symptoms of pelvic floor weakness.
- Trial name
- NCT02617472
- Testing
- Pelvic floor exerciser
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- Lelo Inc.
Pelvic Organ Prolapse (POP), Genital Prolapse
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
- Conditions
- Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
- Trial name
- NCT07066761
- Testing
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 85 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Primary Body Region (Arranged Most Common to Least), Lumbar/SI
ATI Evidence-based Guide Investigating Clinical Services
The goal of this study is to evaluate how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value in patients receiving…
- Conditions
- Primary Body Region (Arranged Most Common to Least), Lumbar/SI, Knee, Shoulder
- Trial name
- AEGIS (NCT02285868)
- Where
- United States
- Volunteers
- 4,000,000 people, healthy volunteers welcome
- Sponsor
- ATI Holdings, LLC
Erectile Dysfunction, Premature (Early) Ejaculation
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation.
- Conditions
- Erectile Dysfunction, Premature (Early) Ejaculation, Premature Ejaculation, Pelvic Floor; Weak
- Trial name
- NCT06425211
- Testing
- Therapeutic exercises, Perineal electromyographic biofeedback, Electrical stimulation
- Where
- Colombia
- Volunteers
- 66 people
- Sponsor
- Boston Medical Group
Urinary Stress Incontinence
Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence
The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence
- Trial name
- NCT00190606
- Testing
- Duloxetine, Pelvic Floor Muscle Training (PFMT), Imitation PFMT
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
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.
Cystocele, Rectocele
Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
- Conditions
- Cystocele, Rectocele, Enterocele
- Trial name
- NCT00833001
- Testing
- GYNECARE PROLIFT+M* Pelvic Floor Repair System
- Where
- 8 sites in Belgium, France and 2 more
- Volunteers
- 126 people
- Sponsor
- Ethicon, Inc.
Internal Rectal Prolapse, Pelvic Floor Ptosis
Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch
The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as…
- Conditions
- Internal Rectal Prolapse, Pelvic Floor Ptosis, Internal Hernia Into the Douglas Pouch
- Trial name
- NCT00836680
- Testing
- Colorectal Stent
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- Gerhard Pejcl Medizintechnik GmbH
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
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