Clinical trials: Pelvic Floor Disorders
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.
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
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
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
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.
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.
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
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
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
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
Stress Urinary Incontinence
Pelvic Floor Muscle Training With a Digital Therapeutic Device to Standard Exercises for Stress Urinary Incontinence
A virtual prospective randomized controlled study to evaluate the efficacy of using the leva® Pelvic Digital Health System (PDHS) to perform PFMT compared to a standard home exercise home program for the treatment of SUI/SMUI.
- Trial name
- NCT04508153
- Testing
- Leva Pelvic Digital Health System, Kegel exercises
- Where
- 3 sites in United States
- Volunteers
- 369 people
- Sponsor
- Renovia, Inc.
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 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