Medical and Academic References for MUTU System

This medical reference page offers detailed sources and academic review.

You can find a more digestible summary of MUTU evidence here!

What problem does MUTU System solve?
Digital Health App Review for the NHS Apps Library
Survey Data Results
Academic Review of Survey Data
Working with NICE, AHSN and HTConnect
Presentation at London Midwifery Conference
Working with the NHS during COVID-19
What other programs claim

What problem does MUTU System solve?

Medical reference | MUTU provides evidence-based proven techniques to improve pelvic and abdominal symptoms from ‘mummy tummy’ or diastasis recti to urinary incontinence, painful sex or prolapse symptoms.

More than 70,000 women worldwide (July 2020) have already purchased the programme. Specialist Pelvic Health Physical Therapists, Surgeons, NHS GP surgeries, Midwives and Hospital Women’s Health Physiotherapists refer patients to MUTU as a safe solution for incontinence, prolapse symptoms, diastasis recti and painful sex, as well as related mental health issues and more general postnatal core strengthening.

Digital Health App assessment for the NHS

Medical reference | ORCHA, NHS Digital Assessors said

“[MUTU System] has met all of the expected compliance standards, and displays evidence of clinical benefits. The product has also shown benefits in terms of reduced risk of surgery, symptom improvement and mental well-being improvement.”

MUTU System Technical Assessment Approval

MUTU System Programme – Available evidence of outcomes approved
“MUTU System Programme is identified as a Tier 2 app, as it provides information and resources surrounding a specific condition area. The product has met all of the expected compliance standards and displays evidence of clinical benefits. The product has also described benefits in terms of reduced risk of surgery, symptom improvement and mental well-being improvement.”

©2020 NHS Digital.

MUTU System Programme – Clinical safety approved
“The product is in the scope of DCB0129. A suitable, completed hazard log and a detailed safety case have both been uploaded following NHS templates, and have been approved. The hazard log and safety case have both been reviewed by a relevantly qualified CSO.”

©2020 NHS Digital.

MUTU System Programme – Data protection approved
“MUTU have supplied all of the necessary documentation and responses to allow the review team to be assured that Data Protection is well managed and all key issues are addressed. The Privacy Policy, Cookie Policy and DPIA submission reflect the responses given. This developer has therefore passed this assessment.

©2020 NHS Digital.

MUTU System Programme – Security approved
Full Code Level Security Assessment (CLSA) Penetration testing and re-testing carried out and passed by Xyone Cyber Security Services.

MUTU System Programme – Usability & accessibility approved
“The product complies with all relevant design standards, such as WCAG 2.1 AA level requirements and ISO 9241-210. The product has also been adequately researched with appropriate processes, and with target users and demographic needs. The app has been through sufficient accessibility testing and a report has been provided. There is also an outlined process for user feedback, and a suitable schedule for improvements.”

©2020 NHS Digital.

Our Accessibility Statement can be viewed here

MUTU System Programme – Interoperability approved
“MUTU does not have any issues in relation to interoperability. This assessment is approved.”

©2020 NHS Digital.

MUTU System Programme – Technical stability approved
“Sufficient evidence provided”

©2020 NHS Digital.

More information on NHS Digital Technical Assessment & Standards here

Survey Data

Medical reference | In November 2018 a Survey was carried out, based on clinical surveys: EPAQ PF, Female Sexual Function Index, Urinary Distress Inventory, Kings Health Questionnaire and Pelvic Organ Prolapse Distress Inventory 6, focussing on three key areas of women’s health:
1. Sexual well being
2. Urinary symptoms
3. Quality of life.

References:
1. https://www.nhs.uk/conditions/pregnancy-and-baby/your-body-after-childbirth/
2. Female Sexual Function Index, Questions 17&19 http://www.fsfiquestionnaire.com/FSFI%20questionnaire2000.pdf
3. EPAQ-PF, Tables 5&8. Jones, G.L., Radley, S.C., Lumb, J. et al. Int Urogynecol J (2008) 19: 1337. https://doi.org/10.1007/s00192-008-0655-2
4. Urinary Distress Inventory, UDI 6 Question 16&17. Refer to appendix. https://www.womenshealthapta.org/wp-content/uploads/2013/12/pfdi-pfiq.pdf
5. Kings health questionnaire. Questions 2,3,4,6&8. https://www.nice.org.uk/guidance/cg171/resources/the-kings-health-questionnairepdf-191574685
6. Pelvic Organ Prolapse Distress Inventory 6 (POPDI 6). Questions 1-4. Refer to appendix. https://www.womenshealthapta.org/wp-content/uploads/2013/12/pfdi-pfiq.pdf

The survey can be viewed here.

Results are from 906 women who had used MUTU System for 6 weeks or more. Responses were anonymised. The results can be seen below:

97% of women who couldn’t successfully locate or engage their pelvic floor muscles before, were able to after using MUTU System
92% of women who had experience bladder symptoms including urinary leakage saw improvement after using MUTU System
88% of women suffering from symptoms of Pelvic Organ Prolapse reported improvement after using MUTU System
89% of women who experienced pain or discomfort during or after sexual intercourse reported an improvement after doing MUTU System
94% of women with diastasis recti (separation of abdominal muscles) reported an improvement after using MUTU System
94% of women who used MUTU System felt an improvement in how they felt about their body and what it is able to do.

You can see the press release announcing these results here, which was featured on BBC Radio 4 Woman’s Hour.

Academic Review of Data – by Dr Suruchi Kothari MBBS, BSc(Hons), MRCGP

Medical reference | Pelvic Floor Muscle Exercises and Function:
A review of an online modality of training

INTRODUCTION

The pelvic floor sits at the bottom of our pelvis. It is an important and highly integrated structure consisting of muscles, ligaments and connective tissue. The pelvic floor has a few key functions:

Maintaining continence – the pelvic floor muscles (PFM) form sphincters around the urethra, vagina and rectum enabling voluntary control of these orifices. This maintains urinary and faecal continence.14

Sexual Function – the muscles of the pelvic floor help maintain blood flow to the vaginal region, by contracting rhythmically to enhance sexual pleasure.13

Support – the pelvic floor supports the pelvic organs e.g. bladder, uterus and colon, and keeps these organs in place.14

Pelvic and Spinal Stabilisation – the transversus abdominis, pelvic floor, deep multifidus and diaphragm form a muscular cylinder, which supports the spine and the pelvis; these muscles work together as a unit to ensure and maintain trunk stability.11,12

BACKGROUND

Childbirth and pregnancy can increase the risk of weakening and injury to the pelvic floor muscles (PFMs) and the perineum1. Approximately half of postpartum women may lose some of the supporting function of the PFMs after delivery1. This weakness can lead to urinary incontinence, faecal incontinence, prolapse of the pelvic floor organs and sexual problems.

Although the exact mechanisms of these physiological changes have yet to be fully established. The increased levels of hormones, which prepare the body for pregnancy and delivery, allow the dense structures to soften and increase the pelvic floor laxity.
As the uterus grows during pregnancy, the pelvic organs are pushed downwards. Resulting in an increase in intra-abdominal pressure; exposing the pelvic floor muscles to stresses and strain4. The hormones and physical changes, as well as the increased pressure on the pelvic floor, play an important role in the development of Pelvic Floor Dysfunction 4,5,6,7.

A systemic review which included over fifteen studies and over six thousand women revealed pelvic floor muscle training reduced urinary incontinence in pregnant women and urinary and faecal incontinence in postpartum women8. Provided there was no serious degree of uterine prolapse and the exercises were followed accurately.8

Prenatal pelvic floor muscle training (PFMT) can decrease symptoms of urinary incontinence9 and improve muscle coordination and produce strong and flexible muscles during labour10. Postnatal PFMT women can effectively reduce the symptoms of pelvic floor dysfunction.8 Furthermore, results of a study looking at pelvic function in nulliparous pregnant women demonstrated the thickness and strength of the pelvic floor muscles in continent pregnant women were found to be higher than in those who suffered from incontinence3.

Mothers to be are most frequently advised to conduct PFMT during the late stage of pregnancy and the early postnatal phase. If PFMT is delayed it is less likely to reduce urinary incontinence.8, 15,16 Guidelines from the National Institute for Health and Care Excellence recommend training pelvic floor muscles as the first point of treatment for women with urinary incontinence and pelvic organ prolapse.19

Currently, PFMT is offered in a range of formats; in person, via internet-based solutions and mobile applications, using devices, through verbal or written instructions provided by health care professionals.

However, performing pelvic floor exercises is not easy; studies have demonstrated that 70% of women were unable to accurately locate and contract their pelvic floor muscles.18 A shortage of PMFT trained physiotherapists, poor attendance at classes and unavailability can add to the challenge in delivering effective in person PFMT.15 Research has also demonstrated there is no additional benefit in combining PFMT with biofeedback, vaginal cones or electrical simulations.20,21

Thus, based on the literature pelvic floor dysfunction interventions need to be started early8, 15,16, must include the provision of effective instructions, must be widely accessible17 and not require a highly trained expert17.

METHODS

Aim:

To assess the efficacy of an online exercise portal which provides the provision of accurate and effective instructions is widely accessible and can be conducted from the comfort of an individual’s home.

MUTU System is an online exercise programme for mother’s and women with low risk pregnancies. The programme includes real time videos, which include MUTU core and pelvic rehabilitation techniques.

To study the impact of this programme a questionnaire was constructed to gain feedback on five key areas based on existing clinical questionnaires. Key areas included;

  1. Ability to accurately identify the pelvic floor
  2. Bladder symptoms including urinary leakage
  3. Symptoms of pelvic organ prolapse
  4. Sexual well being
  5. Quality of life including body confidence
  6. Presence of diastasis recti (separation of abdominal muscles)

DESIGN & SURVEY

Two modes of responses were included as relevant to the question including;
YES/NO questions (polar questions) were used to identify existing symptomatology
A Likert scale ranging from ‘very much improved’ to ‘worsened’ was utilised to measure the change in individual symptoms as a result of conducting the MUTU programme.

This survey was sent to individuals who had used MUTU System for 6 weeks for more and the anonymised results were collated.

RESULTS

906 respondents fully completed the questionnaire.
The responses are collated below the relevant category:

Ability to accurately identify the pelvic floor
97% of women who couldn’t successfully locate or engage their pelvic floor muscles previously, were able to after using MUTU System.

Bladder symptoms including urinary leakage
92% of women who had experience bladder symptoms including urinary leakage saw improvement after using MUTU System.

Symptoms of pelvic organ prolapses
88% of women suffering from symptoms of Pelvic Organ Prolapse reported improvement after using MUTU System.

Sexual well being
89% of women who experienced pain or discomfort during or after sexual intercourse reported an improvement after doing MUTU System.

Quality of life including body confidence
94% of women who used MUTU System felt an improvement in how they felt about their body and what it is able to do.

Presence of diastasis recti (separation of abdominal muscles)
94% of women with diastasis recti (separation of abdominal muscles) reported an improvement after using MUTU System.

Medical reference and clinical papers consulted for the purposes of this academic review:

  1. Swift, S. (2000). The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care. American Journal of Obstetrics and Gynecology, 183(2), pp.277-285.
  2. Kahyaoglu Sut, H. and Balkanli Kaplan, P. (2015). Effect of pelvic floor muscle exercise on pelvic floor muscle activity and voiding functions during pregnancy and the postpartum period. Neurourology and Urodynamics, 35(3), pp.417-422.
  3. MØrkved, S., Salvesen, K., BØ, K. and Eik-Nes, S. (2004). Pelvic floor muscle strength and thickness in continent and incontinent nulliparous pregnant women. International Urogynecology Journal, 15(6), pp.384-390.
  4. Hospital, C., Birmingham, U., University of Alabama at Birmingham, B., Medicine, U., Luzern, K., Hospital, U. and Hospital, P. (2008). Pelvic Floor Re-education | SpringerLink. [online] Link.springer.com. Available at: http://link.springer.com/10.1007/978-1-84628-505-9
  5. Pollack, J., Nordenstam, J., Brismar, S., Lopez, A., Altman, D. and Zetterstrom, J. (2004). Anal Incontinence After Vaginal Delivery: A Five-Year Prospective Cohort Study. Obstetrics & Gynecology, 104(6), pp.1397-1402.
  6. Rortveit, G., Daltveit, A., Hannestad, Y. and Hunskaar, S. (2003). Urinary Incontinence after Vaginal Delivery or Cesarean Section. New England Journal of Medicine, 348(10), pp.900-907.
  7. Viktrup, L., Rortveit, G. and Lose, G. (2006). Risk of Stress Urinary Incontinence Twelve Years After the First Pregnancy and Delivery. Obstetrics & Gynecology, 108(2), pp.248-254.
  8. Boyle, R., Hay-Smith, E., Cody, J. and Mørkved, S. (2012). Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database of Systematic Reviews.
  9. Mørkved, S. and Bø, K. (2013). Effect of pelvic floor muscle training during pregnancy and after childbirth on prevention and treatment of urinary incontinence: a systematic review. British Journal of Sports Medicine, 48(4), pp.299-310.
  10. Salvesen, K. and Mørkved, S. (2004). Randomised controlled trial of pelvic floor muscle training during pregnancy. BMJ, 329(7462), pp.378-380.
  11. Willson, J., Dougherty, C., Ireland, M. and Davis, I. (2005). Core Stability and Its Relationship to Lower Extremity Function and Injury. Journal of the American Academy of Orthopaedic Surgeons, 13(5), pp.316-325.
  12. Akuthota, V., Ferreiro, A., Moore, T. and Fredericson, M. (2008). Core Stability Exercise Principles. Current Sports Medicine Reports, 7(1), pp.39-44.
  13. Woodard, T. and Diamond, M. (2009). Physiologic measures of sexual function in women: a review. Fertility and Sterility, 92(1), pp.19-34.
  14. Perucchini, D. and DeLancey, J. (2008). Functional Anatomy of the Pelvic Floor and Lower Urinary Tract. Pelvic Floor Re-education, pp.3-21.
  15. Reilly, E. T. C., Freeman, R. M., Waterfield, M. R., Waterfield, A. E., Steggles, P., & Pedlar, F. (2002). Prevention of postpartum stress incontinence in primigravidae with increased bladder neck mobility: a randomised controlled trial of antenatal pelvic floor exercises. BJOG: An International Journal of Obstetrics and Gynaecology, 109(1), pp. 68–76.
  16. Gorbea Chávez, V., Velázquez Sánchez, M. del P., & Kunhardt Rasch, J. R. (2004). Effect of pelvic floor exercise during pregnancy and puerperium on prevention of urinary stress incontinence. Ginecologia Y Obstetricia De Mexico, 72, pp. 628–636.
  17. Ewings, P., Spencer, S., Marsh, H., & O’Sullivan, M. (2005). Obstetric risk factors for urinary incontinence and preventative pelvic floor exercises: Cohort study and nested randomized controlled trial. Journal of Obstetrics and Gynaecology, 25(6), pp. 558–564.
  18. Tibaek, S., & Dehlendorff, C. (2014). Pelvic floor muscle function in women with pelvic floor dysfunction: A retrospective chart review, 1992–2008. International Urogynecology Journal, 25(5), pp. 663–669.
  19. Nice.org.uk. (2019). Overview | Urinary incontinence and pelvic organ prolapse in women: management | Guidance | NICE. [online] Available at: https://www.nice.org.uk/guidance/ng123 [Accessed 22 Jul. 2019].
  20. Hay-Smith, J., Bo, K., Berghmans, B., Hendriks, E., de Bie, R. and van Waalwijk van Doorn, E. (2008). Pelvic floor muscle training for urinary incontinence in women. Cochrane Database of Systematic Reviews.
  21. Bø, K. (2003). Is There Still a Place for Physiotherapy in the Treatment of Female Incontinence? EAU Update Series, 1(3), pp.145-153.

Working with NICE, AHSN and HealthTech Connect

Medical reference | MUTU Holdings is a registered NICE (National Institute for Health and Care Excellence) Stakeholder 

  1. Neonatal parenteral nutrition (Feb 2020)
  2. Postnatal care up to 8 weeks after birth (update) (Sep 2020)
  3. Caesarean section (update) (Nov 2020)
  4. Antenatal care for uncomplicated pregnancies (update) (July 2020)
  5. Behaviour change: digital and mobile health interventions (Aug 2020)
  6. Prevention and non-surgical treatment of pelvic floor failure (Aug 2021)

MUTU System founder Wendy Powell is invited to submit comments on these guidelines by the Institute and/or the National Collaborating Centre.

Listed on Innovation Agency Exchange platform, aligned to the AHSN (Academic Health and Science Network) https://www.innovationagencyexchange.org.uk/solutions/mutu-system

Listed on HealthTech Connect platform -‘identifies and supports health technologies that offer measurable benefits to patients and/or the UK health and care system’ – https://www.healthtechconnect.org.uk/

Conference session at London Midwifery Festival

Creator and CEO of MUTU, Wendy Powell was also invited to share the results with NHS and private UK midwives at the London Maternity and Midwifery Festival. Her presentation was on “Non-Surgical Solutions To Diastasis Recti And Pelvic Floor Dysfunction”. You can view the conference session on YouTube here

Healthcare practitioners from across the UK gathered to develop their skills in this sector. These professionals may have been in their job for decades, or they might just be starting out in their first year of training. From a younger generation of midwives right through to the super midwives who’ve helped bring thousands of babies into this world, and worked for years, helping women to birth and recover. No matter their stage, these professionals come together to further their knowledge and continue to learn more around maternal health.

Working in partnership with the NHS during COVID-19

Medical reference | (April 2020) MUTU System is currently delivering trusted pelvic health solutions to vulnerable women in this pilot study in partnership with the Women’s Health Physios department at Norfolk and Norwich University Hospitals NHS Foundation Trust.

100 new mums will receive the MUTU System programme for at-home self-management of pelvic symptoms. We already know that MUTU is a great compliment to women’s health physiotherapy, but during COVID-19 lockdown, patients can’t get to their outpatient appointments. This pilot will gather valuable data as well as provide safe and evidence-based physical and mental health benefits for women at home.

More on MUTU System working in partnership with NNUH NHS Trust here

What other programs claim, and why you should look deeper

Expert Opinion

Medical expertise is, of course, respected and worthy opinion, but ideally it should be specific to the area of practice. relevant. A Nurse, Reflexologist or general Doctor are experts in their field, but not necessarily in the diagnosis and treatment of pelvic floor function, prolapse symptoms, painful sex or diastasis recti. Look for endorsements from specialist women’s health and pelvic health PT’s and Physiotherapists. Surgeons and plastic surgeons who specialise in abdominal and pelvic work, midwives and health professionals working with women’s postnatal physical and mental health issues

Medical or Clinical Evidence

Evidence and research are hugely important for user safety and to demonstrate efficacy. But all research is not created equal. If evidence of outcomes is going to influence your decision (and it’s great that it does!), be certain it’s good evidence. Some examples of misleading evidence might include:

A program that claims to be “The only program clinically proven to resolve diastasis recti” and cites this research as evidence of this. The research paper however, does not substantiate the quoted claim. According to Dr Adam Pollard, PhD MCSM MSc PGCE BSc Hons, “They appear not to have shown the outcomes are equivalent and demonstrated that there is insufficient evidence to suggest that the outcomes are different. To show outcomes are equivalent, a formal equivalence test is required.”

Another program cites a 14-year-old study of 18 pregnant women, to prove the effectiveness of the program to treat a diastasis recti in postnatal women. The University has since withdrawn its support of the method. Dr Adam Pollard: “Conditions are required for a t-test which is cited in the abstract. Sample sizes appear too small, and I could not see whether measurements read are normally distributed. In short, I did not see any justification of how a t-test is applicable to what they want to infer.”

🖤 The proven clinical benefits, safety and security of the MUTU System program are transparent, current, and have been independently audited and assessed for your reassurance by ORCHA, Xyone Cyber Security, and the UK NHS National Health Service Digital Assessors. We also have extensive survey data from more than 900 of our own customers, independently reviewed by a medical academic. Your body confidence, improved symptoms and safety remain our absolute priority 🖤