Female urgency, trial of Urodynamics as routine evaluatio

Not Applicable

• Conditions: Reproductive Health and Childbirth; Pregnancy and Childbirth

• Registration Number: ISRCTN63268739
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-14
• Last Update Posted: 8 July 2024
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1103

Inclusion Criteria

1. Women aged =18 years with refractory OAB or urgency predominant MUI in whom OAB are their most bothersome symptom
2. Have failed conservative treatment (as per NICE guideline e.g. pelvic floor muscle training/ bladder retraining)
3. Have failed or have not tolerated pharmacological treatment (at least 2 different drugs) unless contra indicated
4. Being considered for further treatment

Exclusion Criteria

1. Predominant SUI symptoms
2. Previous urodynamics in the last 12 month
3. Pelvic malignancy or clinically significant pelvic mass
4. Bladder Pain Syndrome
5. Neurological disease (e.g. Parkinson’s disease, Spinal injuries, etc)
6. Urogenital fistulae
7. Previous treatment with BoNT-A/ SNM
8. Previous pelvic radiotherapy
9. Prolapse beyond introitus
10. Pregnant or planning pregnancy
11. Recurrent UTI where a significant pathology has not been excluded
12. Unable to give an informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Participant reported success is measured using the Patient Global Impression of Improvement – Index (PGI-I) at 15 months post randomisation (approximately 12 months post treatment).<br>2. Economic outcome is the incremental cost per quality adjusted life year (QALY) gained of Urodynamics and comprehensive clinical assessment compared to comprehensive clinical assessment only, modelled over the lifetime of the patients