Need for New Stress Urinary Incontinence Treatments
Pelvic floor muscle training (PFMT) is the primary first-line conservative treatment for stress urinary incontinence (SUI) in women. Patients with SUI who perform PFMT on a regular basis have cure rates between 50 to 56% compared to controls.1, 2 However, there is no consensus with respect to the optimal training protocol3-6 and compliance problems exist despite attempts to improve its use. Adding additional methods to PFMT, such as electrical stimulation7 weighted vaginal cones8, mechanical devices9 and different forms of biofeedback,10 have not improved cure rates.11 Surgery is often performed in SUI when PFMT has failed. Both the short- and long-term cure rates for surgical treatment of SUI are superior to PFMT.12 Surgery, however, is not free from complications.12 Due to the moderate rate of success with conservative SUI treatments, lack of compliance with these treatments, and the potential side effects from surgery, there is a need for new treatments with improved continence rates.
- Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database of Systematic Reviews 2010, Issue 1.
- Bø K, Talseth T, Home I. Single blind, randomized controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ 1999; 318: 487–93.
- Dumolin C, Glazener C, Jenkinson D. Determining the optimal pelvic floor muscle training regimen for women with stress urinary incontinence. Neurourol Urodyn 2011; 30:746-53.
- Price N, Dawood R, Jackson SR. Pelvic floor exercise for urinary incontinence: A systematic review. Maturitas 2010; 67:309-15.
- Hay-Smith EJC, Herderschee R, Dumoulin C, Herbison GP. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women: an abridged Cochrane systematic review. Eur J Phys Rehabil Med 2012; 48(4):698-705.
- Rehman H, Bezerra CCB, Bruschini H, Cody, JD. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database of Systematic Reviews 2011, Issue 1.
- Ayeleke RO, Hay-Smith EJC, Omar MI. Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Database of Systematic Reviews 2013, Issue 11.
- Herbison GP, Dean N. Weighted vaginal cones for urinary incontinence. Cochrane Database of Systematic Reviews 2013, Issue 7.
- Lipp A, Shaw C, Glavind K. Mechanical devices for urinary incontinence in women. Cochrane Database of Systematic Reviews 2011, Issue 7.
- Herderschee R, Hay-Smith EJC, Herbison GP, Roovers JP, Heinemann MJ. Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women. Cochrane Database of Systematic Reviews 2011, Issue 7.
- Buckley BS, Grant AM, Tincello DG, Wagg A, Firkins L. Prioritizing research: Patients, carers, and clinician working together to identify and prioritize important clinical uncertainties in urinary incontinence. Neurourol Urodyn 2010;29:708-14.
- Kociszewski J, Kolben S, Barski D, Viereck V, Barcz E. Complications following tension-free vaginal taping: Accurate Diagnosis and complications management. BioMed Res Intern 2015, Article ID 538391.
Flyte System Background
Mechanotransduction and Mechanotherapy
Mechanotransduction (sometimes called mechanical transduction) is the reaction of a cell to sense changes in tension that cause a chemical response. There is a mounting body of evidence that physical forces induce biochemical changes and regulate a large array of physiologic processes.1 Recent studies have shown that physical forces can help to promote skeletal muscle regeneration and heal and strengthen musculoskeletal systems.2,3 Treatments that leverage mechanotransduction for the stimulation of tissue repair and remodeling are called “mechanotherapy”.
The Flyte System was developed by a muscle rehabilitation physician from the Arctic University of Norway, and a Norwegian engineering firm (Ergotest) specializing in training of professional athletes. The team approached the problem by incorporating technology that used mechanotransduction (mechanotherapy) to treat athletes and applied it to the pelvic floor muscle system (PFMS).
The Flyte System delivers mechanotherapy through oscillations. The treatment is provided by an intravaginal probe during pelvic floor muscle training exercises (PFMT).When the Flyte System is used with PFMT, it augments the amount of training load (PFMS total exercise received) by 39 times, as compared to traditional PFMT. This is because the tissues and cells of the pelvic floor, as a pre-stressed system, react instantaneously to each imposed force. This results in much better efficiency in pelvic muscle force transfer and strengthening of the pelvic floor tissues. Initial clinical study results have shown the Flyte System only needs to be used 5 minutes a day for 6 weeks to provide high rates of continence success.4 This is the first device to apply this type of therapy to the PFMS.
Biofeedback to Support Proper Kegel Contractions
The Flyte System includes a handheld control unit that provides a biofeedback function. The vaginal probe measures the orientation and movement of the intravaginal device and informs the patient as to whether they are contracting the PFMS correctly. These measurements help the patient to properly engage the muscles of the pelvic floor.
- Chiou K, Rocks J, Chen C, Cho S, Merkus K, Rajaratnam A, Robison P, Tewari M, Vogel K, Majkut S, Prosser B, Discher D, Liu A. Mechanical signaling coordinates the embryonic heartbeat. Proceedings of the National Academy of Sciences of the United States of America. 2016; 113(32):8939-8944.
- Cezar C, Roche E, Vandenburgh H, Duda G, Walsh C, Mooney D. Biologic-free mechanical induced muscle regeneration. Proceedings of the National Academy of Sciences of the United States of America 2015; 113(6):1534-1539.
- Salanova M, Gelfi C, Moriggi M, Vasso M, Viganò A. et al. Disuse deterioration of human skeletal muscle challenged by resistive exercise superimposed with vibration: evidence from structural and proteomic analysis. FASEB J 2014 Nov; 28(11):4748-63.
- Nilsen I, Rebolledo G, Acharya G, Leivseth G. Mechanical oscillations superimposed on the pelvic floor muscles during Kegel exercises reduce urine leakage in women suffering from stress urinary incontinence: A prospective cohort study with a 2-year follow up. Acta Obstet Gynecol Scand. 2018;00:1-7. https://doi.org/10.1111/aogs.13412
The first clinical study on the Flyte System was conducted at the University Hospital of Northern Norway. Sixty women with leakage between 5g and 50g, demonstrated ability to contract pelvic floor muscles, and stress urinary incontinence (SUI) greater than one year despite supervised pelvic floor muscle training (PFMT), were enrolled. The study included a single treatment arm where the subjects performed daily at-home PFMT for 5 minutes over 6 weeks while using the Pelvital System. The primary endpoint was urine leakage at 6 weeks. Stress tests for urine leakage were performed with a standardized volume of 3dL saline in the bladder. The women in the study who used the Flyte System had a high cure rate for their SUI condition.1
- Nilsen I, Rebolledo G, Acharya G, Leivseth G. Mechanical oscillations superimposed on the pelvic floor muscles during Kegel exercises reduce urine leakage in women suffering from stress urinary incontinence: A prospective cohort study with a 2-year follow up. ActaObstet Gynecol Scand. 2018;00:1-7. https://doi.org/10.1111/aogs.13412
Pelvital Clinical Study: US
The United States Pelvital clinical study is a prospective, randomized parallel group clinical trial, with a one-way cross-over from control to treatment at 6 weeks. Up to 120 patients will be randomized to control or treatment with Pelvital's Flyte System. The treatment arm includes the Flyte System used with pelvic floor muscle training (PFMT) at home for 5 minutes per day. The control arm includes PFMT exercises with a reduced capability sham device at home for 5 minutes per day. The results of both arms will be compared against historical results of the current standard of care. The study duration is 12 weeks, with optional follow-up every 6 months for 24 months.
The primary endpoint is the change in 24-hour urinary pad weight from baseline to 6 weeks. Secondary endpoints will evaluate changes in incontinence-related symptoms and quality of life from baseline to 6 weeks. These objectives will be measured by utilizing a 5-day voiding diary, the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF), the Patient Global Impression of Improvement (PGI-I) and the Incontinence Quality of Life questionnaire (I-QOL).
Key study inclusion and exclusion criteria include the following:
Key Inclusion Criteria
- Female gender
- Ages 18-75
- Clinical diagnosis of stress urinary incontinence
- Ability to contract pelvic floor muscles
- Minimum 10 gram increase at initial 24-hour pad weight test
Key Exclusion Criteria
- Clinical diagnosis of mixed or urge urinary incontinence
- Impaired cognitive function or neurologic conditions
- Physical limitations that impede the patient’s ability to participate (e.g., ability to stand)
- Acute infection or hematuria
- Pregnant or actively trying to conceive
- Previous treatment with biofeedback or similar devices
- Stage III or IV pelvic organ prolapse
NOTE: ClinicalTrials.gov Identifier: NCT02954042