Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence

NCT05624645 | Completed DMC FDA Device

• 1 other identifier: PLX-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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. The main questions it aims to answer are: Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ? Participants will be given one of the devices under study, in addition to educational materials on use of the device, and a treatment schedule. Participants will perform a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, five times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

Conditions

Stress Urinary Incontinence; Urinary Incontinence; Pelvic Floor Disorders

Keywords

stress urinary incontinence; pelvic floor disorders

Outcome Measures

Primary Outcomes (1)

• Change in stress urinary incontinence symptoms

  Patients were given the ICIQ-UI SF, the standard assessment tool for stress and urge urinary incontinence, both before initiation and at the end of study. The difference between the two scores was then assessed to determine whether an change in stress urinary incontinence symptoms occurred after use of the device. ICIQ is the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form is a four question survey to "evaluate the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women." It has a maximum and minimum score of 21 and 0 respectively. Higher scores reflect more significant urinary incontinence symptoms.

  4 weeks

Study Arms (1)

Pelex Upp

EXPERIMENTAL

In this arm, all patients received the device for use in treatment of stress urinary incontinence.

Device: Pelex Upp

Interventions

Pelex Upp DEVICE

Patients were given the Pelex Upp is a non-invasive device that is designed to guide a user through personalized pelvic floor strengthening exercises. Patients used device for four weeks to treat stress urinary incontinence

Pelex Upp

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years of age or older
• Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire

You may not qualify if:

• History of pelvic or lower back surgery
• Pregnancy or less than 12 months post partum
• History of physician-supervised PFMT
• History of Kegel exercises greater than once a month
• History of prior operative delivery
• Self-reported history of pelvic organ prolapse stage II or greater

Sponsors & Collaborators

• Pelex: lead

Study Sites (1)

Pelex

Little Neck, New York, 11363, United States

Location

Related Publications (15)

• Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Dombrowski M, Candib D. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998 Dec 16;280(23):1995-2000. doi: 10.1001/jama.280.23.1995.

  PMID: 9863850 BACKGROUND

• Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.

  PMID: 19937315 BACKGROUND

• Chong EC, Khan AA, Anger JT. The financial burden of stress urinary incontinence among women in the United States. Curr Urol Rep. 2011 Oct;12(5):358-62. doi: 10.1007/s11934-011-0209-x.

  PMID: 21847532 BACKGROUND

• Seyyedi F, Rafiean-Kopaei M, Miraj S. Comparison of the Effects of Vaginal Royal Jelly and Vaginal Estrogen on Quality of Life, Sexual and Urinary Function in Postmenopausal Women. J Clin Diagn Res. 2016 May;10(5):QC01-5. doi: 10.7860/JCDR/2016/17844.7715. Epub 2016 May 1.

  PMID: 27437306 BACKGROUND

• Berghmans LC, Hendriks HJ, Bo K, Hay-Smith EJ, de Bie RA, van Waalwijk van Doorn ES. Conservative treatment of stress urinary incontinence in women: a systematic review of randomized clinical trials. Br J Urol. 1998 Aug;82(2):181-91. doi: 10.1046/j.1464-410x.1998.00730.x.

  PMID: 9722751 BACKGROUND

• KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. doi: 10.1016/0002-9378(48)90266-x. No abstract available.

  PMID: 18877152 BACKGROUND

• Pages IH, Jahr S, Schaufele MK, Conradi E. Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women. Am J Phys Med Rehabil. 2001 Jul;80(7):494-502. doi: 10.1097/00002060-200107000-00006.

  PMID: 11421517 BACKGROUND

• Burns PA, Pranikoff K, Nochajski TH, Hadley EC, Levy KJ, Ory MG. A comparison of effectiveness of biofeedback and pelvic muscle exercise treatment of stress incontinence in older community-dwelling women. J Gerontol. 1993 Jul;48(4):M167-74. doi: 10.1093/geronj/48.4.m167.

  PMID: 8315230 BACKGROUND

• Dumoulin C, Bourbonnais D, Morin M, Gravel D, Lemieux MC. Predictors of success for physiotherapy treatment in women with persistent postpartum stress urinary incontinence. Arch Phys Med Rehabil. 2010 Jul;91(7):1059-63. doi: 10.1016/j.apmr.2010.03.006.

  PMID: 20537314 BACKGROUND

• Herderschee R, Hay-Smith EJ, Herbison GP, Roovers JP, Heineman MJ. Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD009252. doi: 10.1002/14651858.CD009252.

  PMID: 21735442 BACKGROUND

• Glazer HI, Laine CD. Pelvic floor muscle biofeedback in the treatment of urinary incontinence: a literature review. Appl Psychophysiol Biofeedback. 2006 Sep;31(3):187-201. doi: 10.1007/s10484-006-9010-x.

  PMID: 16983505 BACKGROUND

• Moroni RM, Magnani PS, Haddad JM, Castro Rde A, Brito LG. Conservative Treatment of Stress Urinary Incontinence: A Systematic Review with Meta-analysis of Randomized Controlled Trials. Rev Bras Ginecol Obstet. 2016 Feb;38(2):97-111. doi: 10.1055/s-0035-1571252. Epub 2016 Jan 29.

  PMID: 26883864 BACKGROUND

• Barnes KL, Cichowski S, Komesu YM, Jeppson PC, McGuire B, Ninivaggio CS, Dunivan GC. Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2021 Oct 1;27(10):587-594. doi: 10.1097/SPV.0000000000000993.

  PMID: 33208658 BACKGROUND

• Rosenblatt P, McKinney J, Rosenberg RA, Iglesias RJ, Sutherland RC, Pulliam SJ. Evaluation of an accelerometer-based digital health system for the treatment of female urinary incontinence: A pilot study. Neurourol Urodyn. 2019 Sep;38(7):1944-1952. doi: 10.1002/nau.24097. Epub 2019 Jul 16.

  PMID: 31310369 BACKGROUND

• Washington BB, Raker CA, Sung VW. Barriers to pelvic floor physical therapy utilization for treatment of female urinary incontinence. Am J Obstet Gynecol. 2011 Aug;205(2):152.e1-9. doi: 10.1016/j.ajog.2011.03.029. Epub 2011 Mar 22.

  PMID: 21620356 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Study Officials

• Jeremy Wiygul, M.D.

  Pelex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 22, 2022
• Study Start: February 25, 2021
• Primary Completion: August 9, 2021
• Study Completion: January 18, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)