Idiopathic overactive bladder overactive bladder
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the difference in maximum cystometric capacity seen on UDS before and after activation of the PNE. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands