Top

International Urogynecology Journal

Published in:

Open Access 22-01-2024 | Urinary Incontinence | Original Article

A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months

Authors: Milena M. Weinstein, Gena C. Dunivan, Noelani M. Guaderrama, Holly E. Richter

Published in: International Urogynecology Journal | Issue 4/2024

Abstract

Introduction and hypothesis

There are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months.

Methods

Between October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months’ follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores.

Results

A total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 ± 14.5 years, and mean BMI was 31.8 ± 7.4 kg/m². Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (−21.1 ± 24.5 vs −14.8 ± 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35% vs 22%, p = 0.03, OR 1.95(95% CI 1.08, 3.57).

Conclusions

Pelvic floor muscle training guided by a motion-based prescription intravaginal device yielded durable and significantly greater UI symptom improvement than a standard home program, even in the absence of continued therapy.

Available only for authorised users

Patel UJ, Godecker AL, Giles DL, Brown HW. Updated prevalence of urinary incontinence in women: 2015–2018 national population-based survey data. Female Pelvic Med Reconstr Surg. 2022;26:287–98. https://doi.org/10.1097/SPV.0000000000001127.CrossRef

Mendes A, Hoga L, Gonçalves B, et al. Adult women’s experiences of urinary incontinence: A systematic review of qualitative evidence. JBI Database Syst Rev Implement Rep. 2017;15:1350–408.CrossRef

Siddiqui NY, Wiseman JB, Cella D, et al. Mental health, sleep and physical function in treatment seeking women with urinary incontinence. J Urol. 2018;200:848–55. https://doi.org/10.1016/j.juro.2018.04.076.CrossRefPubMedPubMedCentral

Yang E, Lisha NE, Walter L, et al. Urinary incontinence in a national cohort of older women: implications for caregiving and care dependence. J Womens Health. 2018;27:1097–103. https://doi.org/10.1089/jwh.2017.6891.CrossRef

Datar M, Pan LC, McKinney JL, et al. Healthcare resource use and cost burden of urinary incontinence to United States payers. Neurourol Urodyn. 2022;41:1553–62. https://doi.org/10.1002/nau.24989.CrossRefPubMedPubMedCentral

Chisholm LP, Sebesta EM, Gleicher S, et al. The burdens of incontinence: quantifying incontinence product usage and costs in women. Neurourol Urodyn. 2022;41:1601–11. https://doi.org/10.1002/nau.25007.CrossRefPubMedPubMedCentral

Favre-Inhofer A, Dewaele P, Millet P, Deffieux X. Systematic review of guidelines for urinary incontinence in women. J Gynecol Obstet Hum Reprod. 2020;49:101842. https://doi.org/10.1016/j.jogoh.2020.101842.CrossRefPubMed

Pan LC, Datar M, McKinney JL, et al. Adherence to professional society guidelines among women with stress or mixed urinary incontinence. Neurourol Urodyn. 2022;41:1489–97. https://doi.org/10.1002/nau.24986.CrossRefPubMedPubMedCentral

Lamin E, Parrillo LM, Newman DK, Smith AL. Pelvic floor muscle training: underutilization in the USA. Curr Urol Rep. 2016;17:10. https://doi.org/10.1007/s11934-015-0572-0.CrossRefPubMed

10.

Waetjen LE, Xing G, Johnson WO, et al. Factors associated with reasons incontinent midlife women report for not seeking urinary incontinence treatment over 9 years across the menopausal transition. Menopause. 2018;25:29–37. https://doi.org/10.1097/GME.0000000000000943.CrossRefPubMedPubMedCentral

11.

Salmon VE, Hay-Smith EJC, Jarvie R, et al. Implementing pelvic floor muscle training in women’s childbearing years: a critical interpretive synthesis of individual, professional, and service issues. Neurourol Urodyn. 2020;39:863–70.CrossRefPubMed

12.

Pennycuff JF, Borazjani A, Wang H, Iglesia C. Commercially available home pelvic training devices for the treatment of pelvic floor disorders. Obstet Gynecol. 2022;140:275–92. https://doi.org/10.1097/AOG.0000000000004860.CrossRefPubMed

13.

Bernard S, Boucher S, McLean L, Moffet H. Mobile technologies for the conservative self-management of urinary incontinence: a systematic scoping review. Int Urogynecol J. 2020;31:1163–74. https://doi.org/10.1007/s00192-019-04012-w.CrossRefPubMed

14.

Da Mata KRU, Costa RCM, Carbone ÉDSM, et al. Telehealth in the rehabilitation of female pelvic floor dysfunction: a systematic literature review. Int Urogynecol J. 2021;32:249–59. https://doi.org/10.1007/s00192-020-04588-8.CrossRefPubMed

15.

Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital therapeutic device for urinary incontinence. Obstet Gynecol. 2022;139:606–15. https://doi.org/10.1097/AOG.0000000000004725.CrossRefPubMedPubMedCentral

16.

Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. Digital therapeutic device for urinary incontinence: a longitudinal analysis at 6 and 12 months. Obstet Gynecol. 2023;141:199–206. https://doi.org/10.1097/AOG.0000000000005036.CrossRefPubMed

17.

Weinstein MM, Pulliam SJ, Richter HE. Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): an all-virtual trial design. Contemp Clin Trials. 2021;105:106406. https://doi.org/10.1016/j.cct.2021.106406.CrossRefPubMed

18.

American Urogynecologic Society. https://www.voicesforpfd.org/assets/2/6/Bladder_Training.pdf. In: Pelvic Floor Muscle Exercises and Bladder Training. https://www.voicesforpfd.org/assets/2/6/Bladder_Training.pdf. 2016. Accessed 31 May 2020.

19.

Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005;193:103–13. https://doi.org/10.1016/j.ajog.2004.12.025.CrossRefPubMed

20.

Sanderson DJ, Zavez A, Meekins AR, et al. The patient acceptable symptom state in female urinary incontinence. Female Pelvic Med Reconstr Surg. 2021;26:287–98. https://doi.org/10.1097/SPV.CrossRef

21.

Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001;185:1388–95. https://doi.org/10.1067/mob.2001.118659.CrossRefPubMed

22.

Barber MD, Spino C, Janz NK, et al. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Am J Obstet Gynecol. 2009;200:580.e1–7. https://doi.org/10.1016/j.ajog.2009.02.007.CrossRefPubMed

23.

Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2010;(1):CD005654. https://doi.org/10.1002/14651858.CD005654.pub2.

24.

Kim H, Yoshida H, Suzuki T. The effects of multidimensional exercise treatment on community-dwelling elderly Japanese women with stress, urge, and mixed urinary incontinence: a randomized controlled trial. Int J Nurs Stud. 2011;48:1165–72. https://doi.org/10.1016/j.ijnurstu.2011.02.016.CrossRefPubMed

25.

Bø K, Hilde G. Does it work in the long term?—A systematic review on pelvic floor muscle training for female stress urinary incontinence. Neurourol Urodyn. 2013;32:215–23. https://doi.org/10.1002/nau.22292.CrossRefPubMed

26.

Beyar N, Groutz A. Pelvic floor muscle training for female stress urinary incontinence: five years outcomes. Neurourol Urodyn. 2017;36:132–5. https://doi.org/10.1002/nau.22888.CrossRefPubMed

27.

Folland JP, Williams AG. The adaptations to strength training. Sports Med. 2007;37:145–68. https://doi.org/10.2165/00007256-200737020-00004.CrossRefPubMed

28.

Gabriel DA, Kamen G, Frost G. Neural adaptations to resistive exercise. Sports Med. 2006;36:133–49. https://doi.org/10.2165/00007256-200636020-00004.CrossRefPubMed

29.

Bickel CS, Cross JM, Bamman MM. Exercise dosing to retain resistance training adaptations in young and older adults. Med Sci Sports Exerc. 2011;43:1177–87. https://doi.org/10.1249/MSS.0b013e318207c15d.CrossRefPubMed

30.

Dumoulin C, Hay-Smith J, Frawley H, et al. 2014 consensus statement on improving pelvic floor muscle training adherence: International Continence Society 2011 State-of-the-Science Seminar. Neurourol Urodyn. 2015;34:600–5. https://doi.org/10.1002/nau.22796.CrossRefPubMed

Title: A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months
Authors: Milena M. Weinstein
Gena C. Dunivan
Noelani M. Guaderrama
Holly E. Richter
Publication date: 22-01-2024
Publisher: Springer International Publishing
Keywords: Urinary Incontinence
Urinary Incontinence
Published in: International Urogynecology Journal / Issue 4/2024
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-023-05721-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 4/2024

Complete Bladder Eversion after Colpocleisis

Reply to: Uncertainties of the Impacts of Strenuous Physical Activity, Exercise, and Parity on Pelvic Organ Prolapse

Perioperative Morbidity Associated with Same-day Discharge in Elderly Patients

The use of animal models in preclinical investigations for the development of a surgical mesh for pelvic organ prolapse

Validation of the Russian Version of the Prolapse Quality-of-life Questionnaire and its Application to Assess the Impact of Pelvic Organ Prolapse on Quality of Life and the Effect of Treatment in Women Undergoing Reconstructive Surgery

Is Preoperative Type and Screen High-value Care? A Cost-effectiveness Analysis of Performing Preoperative Type and Screen Prior to Urogynecological Surgery