Pelvital Stress Urinary Incontinence Training Device: P-SUIT

Status Completed

Clinical Trial Summary

The purpose of this investigation is to compare the clinical benefits of using the Pelvital product, in comparison to a sham procedure as a noninvasive treatment for female incontinence

Clinical Trial Description

120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects will conduct their respective therapy five minutes a day over the course of six weeks. At weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all patients in the control arm will have the option to cross over into the treatment arm if no improvement in symptoms has been shown. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02954042
Study type	Interventional
Source	Pelvital USA, Inc.
Contact
Status	Completed
Phase	N/A
Start date	March 10, 2017
Completion date	October 30, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02835846` - Investigation of the Effect of the Female Urinary Microbiome on Incontinence	Phase 4
Recruiting	`NCT02978638` - Electrical Stimulation for Continence After Spinal Cord Injury	N/A
Completed	`NCT01978210` - Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism	N/A
Completed	`NCT00972998` - Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects	Phase 1/Phase 2
Completed	`NCT01036035` - Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects	Phase 1
Recruiting	`NCT04110821` - Quality of Life After Conservative and Surgical Treatment of Pelvic Organ Prolapse
Recruiting	`NCT05826691` - Benign Prostate Surgery and QOL and Sexual Function
Recruiting	`NCT05362292` - TReating Incontinence for Underlying Mental and Physical Health	Phase 4
Recruiting	`NCT05935371` - Consequences of Obstetric Anal Sphincter Injuries on Maternal Psychology and Relationship Experience
Completed	`NCT02554201` - Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction	N/A
Completed	`NCT01486706` - Efficacy and Safety of Gabapentin in Treating Overactive Bladder	Phase 2/Phase 3
Completed	`NCT00617786` - CPT Testing for Sacral Neuromodulation Outcomes	N/A
Completed	`NCT02633592` - Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry	N/A
Completed	`NCT01747343` - Toilet Training Toddlers and Preschoolers	N/A
Completed	`NCT01470001` - The Effect of Solifenacin on Post Void Dribbling in Women	N/A
Recruiting	`NCT02091947` - Efficacy of Functional Magnetic Stimulation in Urinary Incontinence	Phase 2
Completed	`NCT01108367` - Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate (HoLEP)	N/A
Completed	`NCT04924218` - Evaluation of the Effect of Endoscopic Urethral Procedures Applied After Radical Prostatectomy on Urinary Incontinence	N/A
Recruiting	`NCT04010292` - Enhancing Patient Recall in Urogynecologic Surgery	N/A
Completed	`NCT05106010` - The Effect of Yoga on Decreasing Risk of Fall-Related Injury in Peri and Post-Menopausal