Pelvic Floor DisordersSUINCT03194789
The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
A study testing Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy and Traditional Pelvic Floor Therapy in people with Pelvic Floor Disorders and Stress Urinary Incontinence, run by Montefiore Medical Center at 1 site in United States.
Trial summary
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar to dynamic… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pelvic Floor Disorders, Stress Urinary Incontinence
- What is being tested?
- Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy and Traditional Pelvic Floor Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 12 Dec 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stress or Mixed Urinary Incontinence, based on UDI-6.
- Females between the ages of 18-75 years.
- Weight less than 350 lbs.
- Ambulatory and active patients that can participate in a rehabilitation program that includes daily walking
- Able to walk at least 50 meters and scored positive on the STEADI test
- Able to understand, read and sign the informed consent form
- English or Spanish speaking
Who cannot join
- Prior surgery for incontinence
- Pelvic Floor Therapy within past 6 months.
- Currently pregnant
- Predominantly Urge Incontinence.
- Patients with more than 3 falls in the last 52 weeks, OR any balance related fall with an injury in the last 52 weeks.
- Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
Show all 12Show fewer
- Patients with a history of pathological osteoporotic fracture
- Any major cardiovascular comorbidities prohibiting enrollment in an active exercise program
- Active heart disease (ischemia or heart failure admissions within 24 weeks) and Active COPD (exacerbation within 24 weeks)
- Active malignancies on ongoing treatment
- Patient with neurological gait pattern.
- Patient requiring assistive device during gait analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center - Medical Park Campuses
The Bronx, New York, 10461
About this study
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population.
Read the detailed description
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM has been shown to cause perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. In support of this theory, although not published, one of the founders of the technique, Avi Elbaz, has noted anecdotal evidence that patients who had SUI (stress urinary incontinence) and underwent FGBMM for knee or low back pain reported improvement of incontinence. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. The pods on the footwear can be positioned to challenge the patients balance in a manner similar to the way trampolines are utilized in LPSE. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. An additional advantage of FGBMM is that this exercise is done with increased intra-abdominal pressure mimicking the condition and the setting when incontinence occurs rather than static exercise that is used in PFT. While performing regular activities, people are naturally squatting and doing other activities that increase intra-abdominal pressure. Furthermore, FGBMM is more practical for people with busy schedules because it can be accomplished with a much smaller time commitment from the patient than traditional PFT since it is done during normal activity. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population.
A potential use of FGBMM using shoes as a addition to traditional pelvic floor therapy may yield a more effective therapy with better adherence. Problems with traditional therapy include poor patient adherence (patients often do not complete the sessions and have poor adherence (about 50%), lack of the continuation in an ongoing program, leading to relapse and need for re treatment or even little clinical benefit. Additionally, access to pelvic floor therapy is limited for many patients since there are not enough available outpatient therapy services to meet the needs of all patients. Finding an additional exercise program that will increase adherence and improve patient outcomes with better clinical benefits is a high priority from both patient care and cost management perspectives.
FGBMM using shoes potentially overcomes many of these issues with improving/modifying abnormal biomechanics of pelvic floor muscles (therefore decreasing incontinence), and a home based exercise program utilizing footwear that causes exercise with normal activity by promoting perturbation. This bio-mechanical approach may significantly improve the symptoms of urinary incontinence in patients with Stress SUI or Mixed urinary incontinence. Capitalizing on the reported excellent adherence and clinical benefit of FGBMM in patients with related conditions, the investigators propose to evaluate the bio-mechanical exercise (wearing an appropriately calibrated shoe at home for a prescribed amount of time each day) as a conservative treatment that may supplement traditional pelvic floor therapy, medications and even surgical intervention for the same in an inner urban city population.
- Being tested
- Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy, Traditional Pelvic Floor Therapy
- Keywords
- FGBMM, LPSE, UDI - 6, UIQ - 7
- Medical subject headings
- Pelvic Floor Disorders, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor TherapyDevice
Participants will have FGBMM using shoes with pertupods along with traditional PFPT over the course of six months. This will include five sessions of gait assessment and re-calibration with daily at home exercise with the device (shoes) over the course of six months. Along with that, participant will receive traditional pelvic floor therapy of six sessions, up-to one sessions every alternate week. This will involve exercise and modalities as decided by medical providers and therapists. Participants will also have a home exercise program prescribed along with each session and for the remainder of six months.
Traditional Pelvic Floor TherapyOther
Participant will receive six sessions of PFPT, up-to one sessions every alternate week. This will involve exercise and modalities as decided by medical providers and therapists. Participants will also have a home exercise program prescribed along with each session and for the remainder of six months.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Pelvic Floor Physical Therapy (PFPT) | Active comparator | Up to six sessions, with one session every alternate week. Receives: Other: Traditional Pelvic Floor Therapy |
| FGBMM plus Traditional Pelvic Floor Physical Therapy (PFPT) | Experimental | Treatment with FGBMM using shoes with pertupods daily at home along with traditional pelvic floor therapy sessions. Receives: Device: Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Stress Urinary Incontinence (SUI) Symptoms
Severity of SUI symptoms was measured using the six-item Urogenital Distress Inventory (UDI-6). The UDI-6 is a validated, patient-reported questionnaire which assesses the severity of symptoms of urinary incontinence. It includes questions evaluating the frequency of urination, incontinence/leakage, difficulty with complete bladder emptying, and pain. Responses on the UDI-6 are rated on a 5-point scale ranging from 0 ("No/Not present") to 4 ("Quite a bit"). Raw scores were summed, averaged, and multiplied by 25 to yield a final score scale ranging from 0-100. Higher scores are indicative of greater distress due to symptom severity. Results are summarized by study arm.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks (~Six months)
Secondary outcomes (7)
Quality of Life as Determined by the Urinary Impact Questionnaire (UIQ-7)
Quality of Life will be determined with the use of the UIQ-7 subscale component of the Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7) questionnaire. Specifically, the UIQ-7 questions within the PFIQ-7 are used to assess the impact of bladder or urine symptoms or conditions on a participant's daily function and activities, social health, or mental health over the prior 3 months. Participants provide responses for each question on 4-point scale ranging from 0 ("Not at all") to 3 ("Quite a bit"). Mean scores are averaged and multiplied by 100/3 to yield an overall possible score of 0-100, such that higher scores are indicative of a greater negative impact on quality of life from pelvic floor dysfunction. Scores are summarized by study arm using basic descriptive statistics.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks (~Six months)
Pelvic Floor Muscle (PFM) Activity - Average Contraction
PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFM average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Average contraction results values are summarized by study arm using basic descriptive statistics.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks (~Six months)
Pelvic Floor Muscle (PFM) Activity - Maximum Contraction
PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFV average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Maximum contraction results values are summarized by study arm using basic descriptive statistics.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks (~Six months)
Pelvic Floor Muscle (PFM) Activity - Average Rest
PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFV average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Average rest results values are summarized by study arm using basic descriptive statistics.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks (~Six months)
Pelvic Floor Muscle (PFM) Activity - Change From Average Contraction to Average Rest
PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFV average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Change From Average Contraction to Average Rest results values are summarized by study arm using basic descriptive statistics.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks (~Six months)
Pelvic Floor Muscle (PFM) Activity - Average Abdominal Contraction
PFM Activity was assessed during each visit by surface electromyography (sEMG). sEMG recording of the pelvic floor muscle activity was conducted via the use of Prometheus CTS 2000 EMG machine and vaginal sensor for optimal recording and was performed after pelvic examinations had been done to ensure there were no contraindications for the use of the probe. Neuromuscular electrical stimulation with 50 HZ was done via the use of the same intra-vaginal probe for the enhancement of the pelvic floor muscles. Electrical signals (microvolts) were measured during specific tasks and PFV average contraction, maximum contraction, and average rest results were calculated and reported in microvolts. Increased amplitude in waveforms, and corresponding result values, were associated with stronger muscle activation and decreased urinary incontinence. Average Abdominal Contraction results values are summarized by study arm using basic descriptive statistics.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks (~Six months)
Adherence to Treatment
Adherence to FGBMM and PFPT was assessed based on self-reporting of in-person PFPT visits and in-person calibration visits (Dual Therapy study arm only) on an end of study questionnaire. Median number of visits is calculated and summarized by study arm.
Measured: Baseline to 24 weeks (~Six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start29 Nov 2017
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to the two arms/groups in a 1:1 ratio. To ensure balance in treatment assignment, a block randomization method was employed. Participants were randomized to either the traditional PFPT group or the dual therapy (PFPT + FGBMD) group using permuted blocks of size 4. This means that within each block of four consecutively enrolled participants, two were randomly assigned to each treatment group. The block assignments were generated using a random number sequence, ensuring that the allocation sequence was unpredictable.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Apos Medical and Sports Technology Ltd.
- Responsible party
- Sponsor
- Investigators
- Anna M Lasak, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194789
- Sponsor's protocol ID
- 2016-7163
- Acronym
- SUI
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2017
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ng K, Cheung RYK, Lee LL, Chung TKH, Chan SSC. An observational follow-up study on pelvic floor disorders to 3-5 years after delivery. Int Urogynecol J. 2017 Sep;28(9):1393-1399. doi: 10.1007/s00192-017-3281-z. Epub 2017 Feb 14.
PubMed 28197646de Souza Abreu N, de Castro Villas Boas B, Netto JMB, Figueiredo AA. Dynamic lumbopelvic stabilization for treatment of stress urinary incontinence in women: Controlled and randomized clinical trial. Neurourol Urodyn. 2017 Nov;36(8):2160-2168. doi: 10.1002/nau.23261. Epub 2017 Mar 27.
PubMed 28346721Barzilay Y, Segal G, Lotan R, Regev G, Beer Y, Lonner BS, Mor A, Elbaz A. Patients with chronic non-specific low back pain who reported reduction in pain and improvement in function also demonstrated an improvement in gait pattern. Eur Spine J. 2016 Sep;25(9):2761-6. doi: 10.1007/s00586-015-4004-0. Epub 2015 May 16.
PubMed 25981205Ghaderi F, Mohammadi K, Amir Sasan R, Niko Kheslat S, Oskouei AE. Effects of Stabilization Exercises Focusing on Pelvic Floor Muscles on Low Back Pain and Urinary Incontinence in Women. Urology. 2016 Jul;93:50-4. doi: 10.1016/j.urology.2016.03.034. Epub 2016 Apr 5.
PubMed 27059833Silva VR, Riccetto CL, Martinho NM, Marques J, Carvalho LC, Botelho S. Training through gametherapy promotes coactivation of the pelvic floor and abdominal muscles in young women, nulliparous and continents. Int Braz J Urol. 2016 Jul-Aug;42(4):779-86. doi: 10.1590/S1677-5538.IBJU.2014.0580.
PubMed 27564290Solomonow-Avnon D, Levin D, Elboim-Gabyzon M, Rozen N, Peled E, Wolf A. Neuromuscular response of hip-spanning and low back muscles to medio-lateral foot center of pressure manipulation during gait. J Electromyogr Kinesiol. 2016 Jun;28:53-60. doi: 10.1016/j.jelekin.2016.02.010. Epub 2016 Mar 9.
PubMed 27016625Tahtinen RM, Cartwright R, Tsui JF, Aaltonen RL, Aoki Y, Cardenas JL, El Dib R, Joronen KM, Al Juaid S, Kalantan S, Kochana M, Kopec M, Lopes LC, Mirza E, Oksjoki SM, Pesonen JS, Valpas A, Wang L, Zhang Y, Heels-Ansdell D, Guyatt GH, Tikkinen KAO. Long-term Impact of Mode of Delivery on Stress Urinary Incontinence and Urgency Urinary Incontinence: A Systematic Review and Meta-analysis. Eur Urol. 2016 Jul;70(1):148-158. doi: 10.1016/j.eururo.2016.01.037. Epub 2016 Feb 10.
PubMed 26874810Utomo E, Korfage IJ, Wildhagen MF, Steensma AB, Bangma CH, Blok BF. Validation of the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) in a Dutch population. Neurourol Urodyn. 2015 Jan;34(1):24-31. doi: 10.1002/nau.22496. Epub 2013 Oct 26.
PubMed 24167010Bush HM, Pagorek S, Kuperstein J, Guo J, Ballert KN, Crofford LJ. The Association of Chronic Back Pain and Stress Urinary Incontinence: A Cross-Sectional Study. J Womens Health Phys Therap. 2013 Jan;37(1):11-18. doi: 10.1097/JWH.0b013e31828c1ab3.
PubMed 23794961Timmermans L, Falez F, Melot C, Wespes E. Validation of use of the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) for impairment rating: a transversal retrospective study of 120 patients. Neurourol Urodyn. 2013 Sep;32(7):974-9. doi: 10.1002/nau.22363. Epub 2012 Dec 31.
PubMed 23281067Hides J, Stanton W, Mendis MD, Sexton M. The relationship of transversus abdominis and lumbar multifidus clinical muscle tests in patients with chronic low back pain. Man Ther. 2011 Dec;16(6):573-7. doi: 10.1016/j.math.2011.05.007. Epub 2011 Jun 8.
PubMed 21641268Haylen 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.
PubMed 19937315Eliasson K, Elfving B, Nordgren B, Mattsson E. Urinary incontinence in women with low back pain. Man Ther. 2008 Jun;13(3):206-12. doi: 10.1016/j.math.2006.12.006. Epub 2007 Mar 23.
PubMed 17363318Barber 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 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
PubMed 16021067Hajebrahimi S, Corcos J, Lemieux MC. International consultation on incontinence questionnaire short form: comparison of physician versus patient completion and immediate and delayed self-administration. Urology. 2004 Jun;63(6):1076-8. doi: 10.1016/j.urology.2004.01.005.
PubMed 15183953