The validation of a new catheter for intermittent Self-Catheterization in female patients; proof of principles

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 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 provide 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).

The current study is set up to validate the working mechanism of the current
design of the FemFlow.

In this Proof of Principle study the working principle of the current design of
the FemFlow will be validated amongst a group of 10 patients. For the
validation of the working mechanism, the FemFlow will be inserted, used and
retracted. The FemFlow will be rated on undesired urine loss and amongst others
the required force for insertion, draining and retraction of the FemFlow.

Since the working mechanism will be tested in patient undergoing pelvic surgery
the only burden will be extension of operation time and minimal risk for
mucosal damage during testing of the catheter.