The aim is to determine the immediate effect of sacral neuromodulation on urodynamic measurements.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be the difference in maximum cystometric capacity
seen on UDS before and after activation of the PNE.
Secondary outcome
Secondary parameters are bladder volume at: first sensation of bladder filling,
first desire to void, strong desire to void, first involuntary detrusor
contraction. The maximum increase in cmH2O during an involuntary detrusor
contraction and voiding diaries after 7 days of PNE.
Background summary
Overactive bladder is a difficult to treat common condition with a high burden
on society. There is still lack of understanding the pathophysiology and
conservative therapies are often ineffective. Sacral neuromodulation is a safe
and effective alternative, however there is still much unknown about the acute
effects om bladder function. In elaborating sacral neuromodulation more insight
is necessary in the effect of sacral neuromodulation on urodynamic measurement.
Study objective
The aim is to determine the immediate effect of sacral neuromodulation on
urodynamic measurements.
Study design
A prospective pilot study in which urodynamic measurements with and without
sacral neuromodulation are compared.
Study burden and risks
No extra hospital visits are required when participating. The burden of the
study is the urodynamic investigation at the day of electrode insertion instead
of having a urodynamic investigation another day prior to the insertion of
electrode.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Have given informed consent.
- Have sufficient knowledge of the Dutch language to understand the informed consent form.
- Are at least 18 years of age.
- Have a voiding frequency of more than 8 times per 24 hours as determined by a voiding frequency chart of 2 days or have predominantly urge urinary incontinence every day at least once.
- Are not adequately treated for OAB with conservative treatment, like life style intervention, medication and pelvic floor therapy.
Exclusion criteria
- Have a positive urinalysis or urine culture.
- Have predominantly stress urinary incontinence.
- Have predominantly bladder pain syndrome.
- Have a neuropathic bladder.
- Have a symptomatic urinary tract infection.
- Have an indwelling catheter.
- Have had radiation therapy of the pelvis.
- Have a urethral stricture.
- Have had bladder cancer.
- Pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62538.078.17 |