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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05624645
• Other study ID #: PLX-001
• Status: Completed
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: January 18, 2022

Study information

• Verified date: November 2022
• Source: Pelex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This will be a prospective cohort study of women > 18 years of age with symptoms of stress urinary incontinence, recruited via an online recruitment tool.

After screening, patients meeting inclusion criteria will be given a study brochure, and then given instructions on how to indicate desire to participate in the study. The patient will then be contacted for study participation, including explanation of study and details and completion of Informed Consent. Participants will then complete a pre-treatment urinary incontinence symptom questionnaire(ICIQ).

After completion of the above, the participants will then 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).

Endpoint of the study will be change in stress urinary incontinence symptoms as measured by the ICIQ. The ICIQ will be collected at 2 time points: before study entry, and at study close.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 18, 2022
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• 18 years of age or older

• Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enuresis
• Pelvic Floor Disorders
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Pelex Upp
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

Locations

Country	Name	City	State
United States	Pelex	Little Neck	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pelex

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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