Acute effect on urodynamic measurements of sacral neuromodulation for treatment of idiopathic overactive bladder.

• Conditions: Idiopathic overactive bladder; overactive bladder; 10004994

• Registration Number: NL-OMON44396
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be the difference in maximum cystometric capacity<br /><br>seen on UDS before and after activation of the PNE.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are bladder volume at: first sensation of bladder filling,<br /><br>first desire to void, strong desire to void, first involuntary detrusor<br /><br>contraction. The maximum increase in cmH2O during an involuntary detrusor<br /><br>contraction and voiding diaries after 7 days of PNE. </p><br>