Enhancing Men’s Health Management at Home with an Easy-to-Use,

App-Connected Prostate Self-Testing Device

Elisabeth Benke

, Simone Gschaidmeier

, Olivier Gentsch

, Hannes Deittert

Sina Martin

, Alexander Preis

and Jörg Franke

Institute for Factory Automation and Production Systems, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany

Earliebirdie, Kolbermoor, Germany

Digmesa AG, Ipsach, Switzerland

info@digmesa.com, hannes.deittert@fau.de

Keywords: Urology, Uroflowmetry, Benign Prostatic Hyperplasia, Prostate Conditions, Men’s Health.

Abstract: A fundamental problem in men's health is that large groups of men shy away from visiting the doctor, and

specifically, often do not take part in early screening tests if they do not have complaints yet. This is

particularly evident in the sensitive field of urology. Benign prostatic hyperplasia (BPH) is one of the most

widespread disorders in ageing men and is associated with an increasing burden on healthcare systems. It is

often underdiagnosed and undertreated and has a substantial impact on the patients’ quality of life. An altered

urine flow curve can be a first clue to BPH. A new developed, easy-to-use prostate self-testing device based

on a Swiss high-precision flowmeter enables men to check their urine flow at home in familiar surroundings.

Via a Bluetooth connection, the results can be transmitted wirelessly and stored in a digital diary so that long-

term developments can be tracked. The self-testing device not only provides men with the opportunity to deal

with their health with low effort and in a discreet way, but also gives them certainty about their prostate health

status.

1 INTRODUCTION

Benign prostatic hyperplasia (BPH) is one of the most

widespread disorders in ageing men (Madersbacher et

al., 2019) and even argued to be one of the most

common diseases of mankind (Vuichoud & Loughlin,

2015). It is associated with high medical and societal

costs and can have an extremely negative impact on

the quality of life of those affected, as they often

suffer from symptoms such as nocturia that affect

their daily lives and those of their partners. Due to the

ageing society, the disorder may become a rising

socio-economic challenge. (Speakman et al., 2015)

BPH is characterised by a change in the size of the

prostate and is often associated with lower urinary

tract symptoms (LUTS), such as urinary incon-

tinence, reduced flow or feeling of incomplete

emptying, which then usually lead to medical

https://orcid.org/0000-0002-6610-4430

https://orcid.org/0000-0002-2146-8265

https://orcid.org/0000-0003-3469-5982

https://orcid.org/0000-0003-0700-2028

consultation (Langan, 2019; Madersbacher et al.,

2019).

A challenge is not only the treatment, but also the

early detection of changes in the prostate. Despite the

distressing symptoms, BPH/LUTS is often under-

diagnosed and undertreated (Speakman et al., 2015)

as large groups of men shy away from going to the

urologist and have insufficient information about

their health status (Müller, 2021). During the

COVID-19 pandemic this problem has further

increased as doctors are visited even less often and

screening services are used less (Nossiter et al.,

2022). It is therefore all the more important to provide

men with an option to assess their urological health

status easily at home.

One of the possible diagnostic methods for the

detection of prostatic disorders is uroflowmetry,

which is non-invasive and by which conditions can be

182

Benke, E., Gschaidmeier, S., Gentsch, O., Deittert, H., Martin, S., Preis, A. and Franke, J.

Enhancing Men’s Health Management at Home with an Easy-to-Use, App-Connected Prostate Self-Testing Device.

DOI: 10.5220/0011778800003414

In Proceedings of the 16th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2023) - Volume 1: BIODEVICES, pages 182-189

ISBN: 978-989-758-631-6; ISSN: 2184-4305

 2023 by SCITEPRESS – Science and Technology Publications, Lda. Under CC license (CC BY-NC-ND 4.0)

detected based on the urine flow curve. With

Kormoran11, an innovative, handy prostate self-

testing device is developed for practical use in private

environment. It is based on a Swiss high-precision

flowmeter and is currently expanded to include a

Bluetooth-based app connection, which enables the

wireless transfer and storage of flow information in a

digital diary. The device is developed to give men the

opportunity to deal with their own health with a low

hurdle at home and to give them orientation and

security about this sensitive topic. Deliberately, the

focus is on a simple, intuitive and comprehensible

design without overwhelming the user with

information.

This paper will first provide an overview of BPH

and the increasing socio-economic challenges

associated with it, before introducing the

Kormoran11 device, its functionality and its testing.

1.1 BPH: Prevalence, Symptoms and

Diagnosis

BPH affects 30-40% of men over the age of 30 and

the prevalence increases almost linearly with age to

70-80% in men over 80 years (Madersbacher et al.,

2019). Also the prevalence of LUTS increases with

age: while around 50% of men over the age of 60

suffer from BPH-caused symptoms, the rate is

already 80% for men over 80 (Miernik & Gratzke,

2020). The symptoms can be divided into different

categories, e.g. storage symptoms such as increased

urination frequency, urination at night or urinary

incontinence, or voiding symptoms such as a slow,

reduced or intermitted stream or terminal dribble

(Gravas & Melekos, 2009; Miernik & Gratzke, 2020).

For BPH diagnosis and in order to assess the

severity of LUTS, the American Urological Associ-

ation (AUA) created the International Prostate Sym-

ptom Score (IPSS), a screening tool consisting of

eight questions. This procedure has also been adopted

by the World Health Organization (WHO). The

questionnaire refers to BPH-related symptoms such

as nocturia, weak urinary stream or incomplete

emptying as well as the patient’s quality of life. Each

answer given by the patient is scored from 0 to 5

points. The total score correlates with the severity of

the symptoms, up to ‘severely symptomatic’ (20 to 35

points). (Barry et al., 1992; Cockett, 1991)

1.2 Socio-Economic Challenges

Due to the high prevalence in the ageing population,

BPH not only presents a medical but also a growing

socio-economic challenge. The economic burden of a

disease is not only composed of direct costs for the

affected patients, such as medication or interventions,

but essentially also of indirect costs to be shouldered

by society, as workforce or participation in public life

may be decreased. According to an estimate by

(Welliver et al., 2022), the cost of treating all men

over 40 in the United States was at least $1.9 billion

in 2013. It is emphasised that these costs are a

minimum due to few non-covered populations and do

not include indirect costs. The authors also found a

steady increase in expenditures by age group, which

is consistent with the age-related increase in the

prevalence of LUTS/BPH. A 2005 study states that

the cost associated with a BPH diagnosis in the US

was $1,536 per year. The authors found that the

average employee with BPH missed 7.3 hours of

work per year, with about 10% of the considered

group reporting some missed work related to BPH

health care encounter. The sum of direct and indirect

BPH-related costs was estimated to be $3.9 billion

annually. (Saigal & Joyce, 2005) Several studies

assessed the LUTS/BPH-related burden for patients

and society and suspect that these will potentially

increase as the proportion of older men in the

population increases. (Devlin et al., 2021; Speakman

et al., 2015; van Exel et al., 2006)

1.3 Early Urological Screenings –

Situation in Germany and

Influence of the COVID-19

Pandemic

Early detection of changes in the size of the prostate

volume enable early observation and treatment of

symptoms. Studies show that only a few men suffer

from LUTS that can be directly attributed to prostate

cancer. However, a change in the prostate size is not

always benign and if a nodular abnormality is present

there is a chance that biopsy will result in a diagnosis

of prostate cancer. (Chang et al., 2012)

For early detection of changes in the prostate,

there is therefore the possibility of in-office

screenings by the urologist. In Germany, an annual

inspection of the external genitalia and palpation of

the prostate are reimbursed by health insurance funds

for all men over the age of 45. However, a 2022 health

insurance research report states that this examination

was only claimed by 21.7% of eligible men in 2020.

(Grobe et al., 2022) Prostatahilfe Deutschland

(Prostate Aid Germany) assumes various causes for

this: shame about unpleasant examinations, fear of a

drastic diagnosis or the understanding of many men

that a doctor is only necessary when they actually

have a health problem and do not seek health care

Enhancing Men’s Health Management at Home with an Easy-to-Use, App-Connected Prostate Self-Testing Device

183

without complaints. In addition, some men are simply

not used to talking about their physical or mental

sensitivities. (Müller, 2021) Figures in the report in

(Grobe et al., 2022) further suggest that the COVID-

19 pandemic may have led to even fewer people

taking advantage of early prostate screenings.

Compared to 2019, the number of men undergoing

the examination has decreased by 7.7%.

This connection with the COVID-19 pandemic is

underlined by further recent studies. Nossiter et al.

found that the number of men newly diagnosed with

prostate cancer in 2020 after the first lockdown

decreased by 30.8% in England compared to the same

period in 2019, while those diagnosed were at a more

advanced stage of disease. (Nossiter et al., 2022) A

Swedish study by Fallara et al. comes to a similar

conclusion. During the period of March - June 2020

36% fewer cases of prostate cancer were registered

compared to the corresponding periods in 2017 -

2019. The greatest decrease of 51% was seen in men

aged 75 and older. In contrast, there was no decrease

in the numbers of patients receiving cancer curative

treatments. (Fallara et al., 2021) There is a strong

presumption that there is a link between habits

changed by the COVID-19 pandemic and the use of

health services, which has a particular impact on older

people.

2 PROSTATE SELF-TESTING

DEVICE FOR DISCREET USE

AT HOME

Since large proportions of men shy away from

professional urological in-office examinations, a need

arises for options to discreetly deal with the health of

their prostate at home. With Kormoran11, an

innovative, handy flowmeter is developed for

practical use in private environment. The self-testing

device evaluates the urine flow curve and thus gives

clues to the impairment of it by an enlarged prostate.

The latest research approaches also deal with the

extension to wireless evaluation and storage of the

data in an app application. The device is patented

under DE Patent No. 10 2014 008 760 B4 (Beck-

Gschaidmeier & Simmons, 2014).

A challenge with regard to BPH diagnosis is that

the patient self-assesses the severity of his LUTS

when using the IPSS tool described in 1.1. An

objective assessment of the severity of his symptoms

is hardly possible with this procedure; moreover, the

patient has to remember all micturition situations of

the last month and several pages of paper have to be

filled out by hand. The Kormoran11 is supposed to

offer a better alternative for this procedure that is

quicker and less complicated. Especially with regard

to question 5 of the IPSS (Barry et al., 1992) the

device can be a suitable substitute:

Over the past month, how often have you had a weak

urinary stream?

o Not at all (0 points)

o Less than 1 time in 5 (1 point)

o Less than half the time (2 points)

o About have the time (3 points)

o More than half the time (4 points)

o Almost always (5 points)

2.1 Basics of Uroflowmetry

Uroflowmetry is a recognised procedure to confirm

the suspicion of bladder emptying disorders in men.

It records the volume of urine leaving the urethra per

unit time during a micturition. The result is the urine

flow rate measured in mL/sec, which can be displayed

as urine flow curve. Uroflowmetry has the advantage

of being non-invasive and does not require the use of

a catheter. It can therefore be used in almost all

patient groups with suspected bladder emptying

disorders. The measured maximum urine flow rate

max

is the parameter that plays the most important

role in clinical observation and is considered reliable

and easily comparable regarding prognostic and post-

therapeutic assessments. It is, however, important to

ensure that the micturition volume is at least 150 mL,

otherwise the validity of the measurement is limited.

(Hautmann & Gschwend, 2014; Schultz-Lampel et

al., 2012)

The normal urinary flow curve is bell-shaped and

may be slightly flatter on the right side. The urine

flow increases continuously to reach a peak and then

decreases. Figure 1 shows the typical course of a flow

curve.

Figure 1: Schematic representation of a normal urinary flow

curve. (Schultz-Lampel et al., 2012).

BIODEVICES 2023 - 16th International Conference on Biomedical Electronics and Devices

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Some subsequent dripping, as shown in Figure 1

by the two posterior maxima, may occur and is not

necessarily a pathological symptom.

A maximum flow rate of more than 20 mL/sec is

often considered normal. However, this rough

guideline is subject to restrictions and cannot be

generalised as the flow rate depends on the voiding

volume, age and sex. According to the ‘Liverpool

nomogram’ by Haylen et al. which aims to better

distinguish normal urine flow values from

pathological values for different population groups,

the curve of the 25th percentile of men > 50 years

shows a maximum flow rate of approx. 11 mL/sec at

a voiding volume of 150 mL. As the voiding volume

increases, the flow rate of the considered group

increases to about 15 mL/sec at 500 mL. (Haylen et

al., 1989) In the guideline on therapy of benign

prostatic syndrome, published by the association of

German urologists, a flow rate with Q

max

< 10 mL/sec

is considered ‘reduced’ and may indicate an

obstruction of the urine flow. (Dreikorn & Höfner,

2014) In general, Q

max

> 12…15 mL/sec is

considered 'normal' in the literature, even though it

must be mentioned that parameters in uroflowmetry

are subject to great variation and a definitive normal

range cannot be defined. (Jarvis et al., 2012)

2.2 Home Uroflowmetry

The idea of home uroflowmetry was first suggested

by Blaivas in 1988 to counter disadvantages of single-

episode office uroflowmetry (Boci et al., 1999).

Literature indicates that the latter procedure may not

be sufficiently reliable to detect certain BPH-related

voiding dysfunctions since many patients are unable

to relax and void urine in a normal way in clinical

environment. In addition, possible variations between

consecutive flow measurements and circadian

changes may have an impact on various voiding

parameters, specifically on the peak flow rate.

(Golomb et al., 1992)

Boci et al. conducted a study in 1999 to

compare home uroflowmetry to conventional, free

office uroflowmetry. 25 male patients at a mean age

of 67 years with symptomatic BPH performed both

free and home uroflowmetry. It was found that 80%

of the investigated patient group considered home

uroflowmetry simpler and more acceptable. 60% of

the patient group felt psychologically better using

home uroflowmetry. However, the crucial restriction

was found that the device to be used at home must be

explained to the patient in an understandable way.

(Boci et al., 1999)

2.3 Device Architecture and

Functionality

The aim was to develop a device with which the urine

flow can be checked at home in familiar surroundings

to give men certainty about their health status. From

the literature and clinical feedback, the self-testing

device should be easy to use and understand by non-

professionals. The Kormoran11 is intended to serve

for self-monitoring in case of a suspected new

decrease in urine flow, to observe the consequences

of medication treatment or after surgical intervention

on the urethra or prostate. As pictured in Figure 2, the

device consists of a funnel and a measuring unit in

which the flow rate is evaluated. A high precision

turbine-based flow measurement method (Digmesa

AG, Ipsach, Switzerland) is used for this purpose. The

sensor system consists of a reed switch, which is

integrated in the circuit board, and permanent

magnets, with which 2 of the 4 turbine blades are

equipped. To set the turbine in rotation, the outer area

of the rotor blades is exposed to the flow, as indicated

in Figure 2. When the user urinates into the funnel,

the flow is directed through the measuring unit and

leaves it at the outlet. To assess the urine flow, the

measured peak value of the flow curve is compared

with the maximum flow rate of Q

max

=11 mL/sec. If

the critical value is exceeded, a green led lights up on

the device when the measurement is completed;

otherwise, there is a red led signal. The housing of the

pictured measuring unit is injection moulded.

Figure 2: Prostate Self-Testing-Device Kormoran11,

consisting of a funnel (1) into which urine is passed, a flow

channel (2), the flow measuring unit (3) and a circuit board

with microcontroller, reed switch, battery and LED lights (4).

The yellow arrow indicates the course of the flow channel.

Enhancing Men’s Health Management at Home with an Easy-to-Use, App-Connected Prostate Self-Testing Device

185

Figure 3: Schematic diagram of the device architecture and the integrated circuit board. The outer white box represents the

Kormoran11 device, the circuit board is shown in green. It is equipped with the nRF52832 Bluetooth Low Energy Module

by Adafruit. The processing of the measurement data takes place on the circuit board so that information can be provided also

directly on the device via the red and green led lights (indicated by the red and green triangles).

A digital version of the device contains a Bluetooth

module, which allows the wireless transmission of the

results to a smartphone. There the measured data can

be stored in a flow rate diary in order to track long-

term developments, which can give the user and

urologist indications of possible pathological

changes.

Figure 4: Prototyped user interface of the flow rate diary.

Green and red dots indicate whether the target value

max

=11 mL/sec has been reached or not.

Figure 3 shows a schematic diagram of the device

architecture. For the Bluetooth connection, the

integrated circuit board is equipped with the

nRF52832 Bluetooth Low Energy Module by

Adafruit (New York, United States). It has a BLE

radio (Nordic Semiconductor, Trondheim, Norway),

the supporting circuit and a Bluetooth antenna already

integrated and measures only 10 x 16 mm. The

processing of the measurement data takes place on the

board so that it can provide information also directly

on the device via the red and green led lights. For app

connected use, the device is placed next to a

Bluetooth-enabled smartphone and the recording can

be started in the app. The flow data is then transmitted

continuously during the measurement, followed by

the red or green indicator. In the app the result of the

measurement is provided with the date and time, so

that the flowmetry results can be observed over a

longer period. Figure 4 shows the prototyped user

interface. Green and red dots indicate whether the

target value of Q

max

=11 mL/sec has been reached on

certain days or not.

2.4 Testing of the Device

Functionality and accuracy of the Kormoran11 were

determined in laboratory in various flowmetry tests

on a test bench. Water was used as the test liquid. A

measuring programme with 13 measurement points

was carried out for each test. On the test bench, which

is pictured in Figure 5, the flow rate is varied with the

aid of a controllable flow regulator. To determine the

average flow rate, a valve is opened for a

measurement period of 7 seconds and the amount of

liquid passed is measured using digital scales. As

water passes through the measuring unit of the device,

it causes the turbine to rotate. The rotation of the

turbine blades is detected magnetically and converted

into electric pulses. The sensor pulse frequency is

directly related to the turbine speed and thus to the

flow velocity.

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Figure 5: Laboratory testing of the Kormoran11 device on

a test bench. The flow rate can be varied using a

controllable flow regulator; the amount of liquid passed is

measured using digital scales.

Figure 6 shows the relationship between the

frequency of detected sensor pulses and the flow rate

around the critical range of the switching point over a

measurement series consisting of eight single measur-

ements. This gives information about the

performance of the sensor over the flow rate. The

resulting curve is used to calibrate the device and

requires repeatability and linearity. It can be seen that

from about 580 mL/min the curves lie well together

on almost a straight line, which shows good repetition

over the test series.

Figure 6: Detected sensor pulses as a function of the flow

rate around the critical range of the desired switching point

of 0.66 L/min.

In order to show the accuracy and reliability of the

sensor unit, the LED switching points from RED to

GREEN were also examined in various tests. Figure 7

shows the results of an exemplary series with eight

single measurements. A value of −1 corresponds to

RED and +1 corresponds to GREEN. This allows the

display of the flow rate at which the transition from

RED to GREEN was indicated for each test in the

series.

Figure 7: Switching point from RED to GREEN for a

measurement series of eight tests. A value of -1 corresponds

to RED and +1 corresponds to GREEN.

From Figure 7 it can be observed that below

588 mL/min the sensors in all tests indicate RED, the

first sensor indicating GREEN does so at

635 mL/min. The last sensor to indicate RED is at

658 mL/min. At 729 mL/min, all sensors indicate

GREEN. The aim was to reliably determine the value

of 660 mL/min (equals Q

max

=11 mL/sec) with a band

of +/-10%, i.e. from 594 to 726 mL/min. This can be

confirmed by this series of measurements.

3 CONCLUSIONS

In this paper, the newly developed, easy-to-use

prostate self-testing device Kormoran11 is presented,

which enables men to assess their urine flow simply

and discreetly in the familiar surroundings of their

own home. The application of the device represents

not only a low hurdle when men do not want to go to

the urologist or first approach the sensitive subject

themselves. It also enables repeated and regular

measurement to obtain as much certainty as possible

despite fluctuating parameters that have an influence

on urine flow, such as circadian changes. The

Kormoran11 signals whether normal urine flow is

ensured and indicates possible changes in the

prostate, bladder or urethra. The device has been

shown to operate accurately and to have high

repeatability in detecting the set Q

max

value of

11 mL/sec. The operation is simple and the indication

with a red and green led light is easy to understand.

350 450 550 650 750 850 950 1050

Pulses (sec

)

Flow rate (mL/min)

Sample 1

Sample 2

Sample 3

Sample 4

Sample 5

Sample 6

Sample 7

Sample 8

-1,5

-1

-0,5

0,5

1,5

3504505506507508509501050

LED signal (+1 GREEN, -1 RED)

Flow rate (mL/min)

Sample 1

Sample 2

Sample 3

Sample 4

Sample 5

Sample 6

Sample 7

Sample 8

Enhancing Men’s Health Management at Home with an Easy-to-Use, App-Connected Prostate Self-Testing Device

187

In a version without app connection, the Kormoran11

is already approved as a medical device and available

on the market.

The digital functions and the app connection were

introduced specifically at the suggestion of the

urologists accompanying the project. It is expected

that the possibility of observing the long-term

development of measurements will enable a better

medical assessment and that the device will also be

accepted and used by younger users. However, with

regard to the older target group, it should be noted that

a digital connection is not necessary to fulfil the

function of Kormoran11.

It must be emphasised that the self-test result can

only be a first indication and that the final diagnosis

by a urologist is essential. The device is intentionally

not a measuring instrument, but serves to introduce

men to the sensitive subject in a simple way and to

familiarise themselves with their prostate health

status. The user is educated that a red light means that

the current flow is too weak. He is instructed to repeat

the measurement on other days at other times in that

case. If the signal is predominantly red, a visit to the

doctor is advised.

In conclusion, the authors are convinced that this

work can make a great contribution to men's health.

However, future studies need to test the willingness

of men to purchase and use the Kormoran11 device

and further development work is needed to make the

app-connected version ready for series production. In

addition to home use, it is also conceivable that the

device could be used in day care, nursing homes and

general practitioners’ offices.

ACKNOWLEDGEMENTS

This project was partly funded by the Bavarian

Ministry of Economic Affairs, Regional Develop-

ment and Energy. The patent process was funded by

the Federal Ministry for Economic Affairs and

Energy as part of the SIGNO initiative. The authors

would further like to express their gratitude for the

medical support provided to the project by

Prof. Thomas Ebert, Head of the Prostate Centre of

the Nuremberg Metropolitan Region, St. Theresien

Hospital Nuremberg.

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