Detrusor overactivity, dysfunctional voiding Nervous System Diseases
Conditions
Interventions
This protocol covers a series of pilot studies. All patients will receive the SNM standard of care if involved in this study with the addition of UDS investigations at different time points (see flow
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study 1 and 2: Male and female patients with refractory OAB symptoms, diagnosed with DO on UDS Study 3: Female patients with refractory voiding dysfunction and evidence of high-tone non-relaxing sphincter on UDS and urethral pressure profilometry
Exclusion criteria
Exclusion criteria: 1. Anatomical abnormalities in the genitalia or pelvic region 2. Women who plan to become pregnant 3. Patients expecting to have diathermy treatment 4. Patients with neurological disease 5. Anticoagulants 6. Any other condition that would prevent the patient from completing the study, as judged by the principal investigator 7. Involvement in other current or recent research trials (3 months) 8. Non-English speaking and those lacking capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pilot 1: Bladder function measured during a urodynamic assessment between day 7 and 14 at each of the following stimulation frequencies 5, 14 and 130Hz (the assessment will include four filling phases). Parameters include: capacity (ml), compliance (ml/cmH2O), detrusor overactivity peak pressure and onset (cmH2O and ml respectively), voided volume (ml), detrusor pressure at peak flowrate, Pdet.Qmax (cmH2O), maximum flowrate, Qmax (ml/s), post void residual (ml). Pilot 2: Bladder function parameters measured during urodynamic assessments on day 4, 9 and 14 at a different stimulation frequency (5, 14 or 130Hz). Parameters include: capacity (ml), compliance (ml/cmH2O), detrusor overactivity peak pressure and onset (cmH2O and ml respectively), voided volume (ml), detrusor pressure at peak flowrate, Pdet.Qmax (cmH2O), maximum flowrate, Qmax (ml/s), post void residual (ml). Pilot 3: Uroflowmetry parameters measured using the Minze HomeFlow device throughout the two week trial. Parameters include voided volume (ml), maximum flow rate (ml/s), average flow rate (ml/s) and shape of flow. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pilot 1 and 2: -Bladder diary parameters recorded during the two week trial. Parameters include voided volume (ml), number of voids /day and number of incontinence episodes / day. -Patients subjective response to treatment measured using the ICIQ-OAB questionnaire on day 4, 9 and 14. Pilot 3: -Patients subjective response to treatment measured using the ICIQ-FLUTS questionnaire on day 4, 9 and 14. | — |
Countries
England, United Kingdom
Contacts
Public ContactEskinder Solomon
Outcome results
None listed