Patient comfort assessment of the Femflow. A follow-up study of the validation of a new catheter for intermittent Self-Catheterization in female patients

Patients suffering from lower urinary tract dysfunction such as neurogenic
bladder dysfunction (caused by e.g. spinal cord injury, cerebrovascular
disease, Parkinson*s disease) and bladder retention (caused by e.g. urethral
obstruction, neurological disease, unknown causes) or taking medication that
affects the contractility of the detrusor muscle commonly have voiding
difficulties. These difficulties can be: obstructed voiding, incomplete bladder
emptying or complete urinary retention. As a result patients may suffer from
urgency/frequency or Urge Urinary Incontinence, nocturia and the risk of
recurrent urinary tract infections (UTIs), bladder stones and eventually renal
insufficiency. Intermittent self-catheterization (ISC) has become the golden
standard for the treatment of patients with obstructed voiding, incomplete
bladder emptying and urinary retention. The International Continence Society
defines ISC as the use of a technique to drain the bladder with subsequent
removal of the catheter, which is performed by the patient itself. ISC provides
better symptom management and reduces incontinence episodes and UTIs.
Furthermore it greatly improves Quality of Life (QoL) by increasing the
patients* confidence and independence, resulting in greater freedom to
participate in daily and social activities. ISC is favored over an indwelling
catheter because it has various health advantages such as a lower risk on UTIs
and kidney infections and better self-management. Patient compliance or
adherence, described by the World Health Organization as the extent of which a
person*s behavior corresponds with agreed recommendations from a health care
professional, is of large influence on the success and Quality of Life of the
patient. Partial or no adherence to the ISC recommendations can result in major
urological complications. The barriers for adherence can be divided into two
main factors. The first is patient related and dependent on physical
disabilities and psychological factors such as (fear for) pain during ISC. The
second is related to external factors such as access to public toilets,
inadequate facilities in public toilets and availability of appropriate
catheters and assistance appliances, quality of teaching and training for ISC.
Various types of catheters exist: Coated or pre-lubricated, hydrophilic-coated
or uncoated (with separate lubrication) which come in different lengths and
shapes. The most commonly used are disposable and used only once. The choice
for the type of catheter depends on the functional and cognitive ability of the
patient, but also on the ease of use (opening the package and manipulation),
package discretion and costs. Another disadvantage of common used catheters is
that they are disposables and therefore used only once. Current ISC catheters
need to be inserted every micturition, because they are disposable.
Furthermore, when applying objects through the urethra several times a day,
this may cause mucosa irritation. To overcome these problems in female
patients, the FemFlow has been developed. The FemFlow is a new type of catheter
which is inserted and removed only once per day. Once inserted into the
bladder, the patient can empty the bladder simply by pulling a cord at any
point in time. The FemFlow will then expand which will open the urethra,
allowing the bladder to be emptied. The current development stage of the
FemFlow is *proof of principle*. The FemFlow is operated as follows: I.
Insertion into the bladder via the urethra (once a day). II. Pull the cord for
emptying the bladder, let go of the cord when bladder is empty (may be repeated
multiple times a day). III. Remove FemFlow by pulling the removal cord (once a
day).

Primary Objective: This study is set up to validate the patient comfort of the
current design of the FemFlow. For the validation of the patient comfort, the
FemFlow will be rated on:

Comfort during insertion
Comfort of an alien object in the bladder
Comfort during urinating
Comfort of FemFlow for several body postures
Comfort during removal of FemFlow

The primary objectives will be rated with a questionnaire.

Study procedures
All patients will receive a patient information letter and will be fully
instructed by the study investigator. After oral and written instructions
patients have to give their approval by signing an Informed Consent form.

1. At the beginning of the patient visitation, the investigator shall start
with the FemFlow research protocol.
2. The bladder will be checked for deformations and abnormalities of the mucosa
or other factors that might influence the correct working of the FemFlow by
urethra-cystoscopy. When any abnormalities are found, the research protocol
will stop.
3. The FemFlow will be inserted into the bladder by or under the supervision of
the Principle Investigator. The patient is asked several questions about the
comfort of insertion of the FemFlow as part of a questionnaire.
4. The patient will be asked to drain the bladder twice within a 2-hour period
by pulling the drain-cord. The patient will be required to remain in close
proximity of the research facility during these 2 hours in case any assistance
of the Principle Investigator is required. That means that the patient is asked
not to leave the hospital.
5. At the end of the visit, a questionnaire will be handed over to the patient
for them to fill in after each draining session. The patient is asked several
questions about the comfort of the FemFlow in the bladder during sitting,
standing and supine position.

Investigation takes 3 hours.
Possible mucosale damage during insertion of extraction of the FemFlow.
Possible hinder if cystoscopic removal is needed.