Ignite Creation Date:
2024-05-06 @ 12:17 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03727711
Status:
UNKNOWN
Last Update Posted:
2018-11-01
First Post:
2017-08-11
Brief Title:
TPTNS Home vs Hospital Treatment for Overactive Bladder
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
Transcutaneous Tibial Nerve Stimulation as a Conservative Treatment for Overactive Bladder Dysfunction -A Randomised Controlled Trial Comparing Home Versus Hospital Based Treatment
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of home versus hospital Transcutaneous Posterior Tibial Nerve Stimulation TPTNS TPTNS has been shown to be an effective treatment of overactive bladder in hospital We aim to see if this effect is replicated at home
80 patients will be recruited 40 into each arm
Inclusion criteria
1 Women aged 18 years
2 Clinical diagnosis of Overactive Bladder OAB
3 Post-void residual urine volume of 100ml
4 Able to do questionnaires
5 Able to consent and willing to participate
Exclusion Criteria
1 Cardiac pacemaker in situ
2 Leg ulcerskin condition affecting both lower legs
3 Diagnosed peripheral vascular disease
4 Absent sensation at the electrode site
5 Current Urinary Tract Infection UTI - must be treated with appropriate antibiotics as per the unit protocol prior to commencing study
6 Pregnancy
7 Previous Percutaneous Tibial Nerve Stimulation PTNS Sacral Nerve Stimulation SNS course
8 Previous intravesical botox treatment
9 Unable to complete questionnaires
TPTNS will be taught to the home group and delivered to the participants in the hospital group in individual appointments 12 treatment sessions of 30 minutes duration delivered twice weekly over a 6 week period Two surface electrodes are applied to the right ankle These electrodes are attached to an electrical stimulator programmed to safely deliver electric pulses
On completion of 6 sessions all participants will be contacted and asked to do a Patient Global Impression of Improvement Scale PGIIS and Patient Perception of Bladder Condition PPBC After 12 sessions the final treatment session all participants will be reviewed by the investigators in the hospital and the outcome measures repeated Participants receiving home treatment will be posted out a 3 day bladder diary to complete At this point the participants receiving home treatment will return the machine All participants will complete and return a 72-hour bladder diary and validated questionnaires routinely used at the study centre to measure lower urinary tract symptoms - The International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms ICIQ-FLUTS long form the International Consultation of Incontinence Modular Questionnaire - Urinary Incontinence questionnaire ICIQ-UI short-form The Hospital Anxiety and Depression Scale HADS and the European Quality of Life - 5D Questionnaire EQ-5D will also be measured
80 patients will be recruited 40 into each arm
Inclusion criteria
1 Women aged 18 years
2 Clinical diagnosis of Overactive Bladder OAB
3 Post-void residual urine volume of 100ml
4 Able to do questionnaires
5 Able to consent and willing to participate
Exclusion Criteria
1 Cardiac pacemaker in situ
2 Leg ulcerskin condition affecting both lower legs
3 Diagnosed peripheral vascular disease
4 Absent sensation at the electrode site
5 Current Urinary Tract Infection UTI - must be treated with appropriate antibiotics as per the unit protocol prior to commencing study
6 Pregnancy
7 Previous Percutaneous Tibial Nerve Stimulation PTNS Sacral Nerve Stimulation SNS course
8 Previous intravesical botox treatment
9 Unable to complete questionnaires
TPTNS will be taught to the home group and delivered to the participants in the hospital group in individual appointments 12 treatment sessions of 30 minutes duration delivered twice weekly over a 6 week period Two surface electrodes are applied to the right ankle These electrodes are attached to an electrical stimulator programmed to safely deliver electric pulses
On completion of 6 sessions all participants will be contacted and asked to do a Patient Global Impression of Improvement Scale PGIIS and Patient Perception of Bladder Condition PPBC After 12 sessions the final treatment session all participants will be reviewed by the investigators in the hospital and the outcome measures repeated Participants receiving home treatment will be posted out a 3 day bladder diary to complete At this point the participants receiving home treatment will return the machine All participants will complete and return a 72-hour bladder diary and validated questionnaires routinely used at the study centre to measure lower urinary tract symptoms - The International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms ICIQ-FLUTS long form the International Consultation of Incontinence Modular Questionnaire - Urinary Incontinence questionnaire ICIQ-UI short-form The Hospital Anxiety and Depression Scale HADS and the European Quality of Life - 5D Questionnaire EQ-5D will also be measured
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None