Overactive Bladder Clinical Trial
— INTENSEOfficial title:
INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder
NCT number | NCT05309993 |
Other study ID # | 20-003 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 30, 2022 |
Est. completion date | December 31, 2024 |
The objective of this research is to perform a non-masked, non-inferiority randomized controlled trial to assess the quality of life (QOL) of women with idiopathic overactive bladder (OAB) before and after treatment with percutaneous tibial nerve stimulation (PTNS) or transcutaneous electrical nerve stimulation (TENS) of tibial nerve. The target population is patients with OAB who previously failed first- and second-line treatments and desire non-surgical management.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female Subjects =18 years of age - OAB, UUI or Mixed Urinary Incontinence with urgency predominant symptoms and more bother from UUI than stress urinary incontinence - Failed trial of conservative therapy (including bladder training, fluid modification, diet modification, caffeine restriction, or pelvic floor training) -Failed trial of at least one pharmacologic treatment (anticholinergics, ß3- adrenoceptor agonist) either due to inability to take the medication, adverse reaction to medication, or no improvement on medication - Willing to complete study questionnaires - Willing to adhere to 12 office visits for PTNS over 3 months if randomized to that arm - No contraindication to undergoing PTNS or TENS therapy Exclusion Criteria: - Age < 18 years - Presence of urinary fistula - Male genital anatomy - Undergoing evaluation or treatment of recurrent (2 or more infections in the last 6 months or 3 or more infections in the last 12 months) or current urinary tract infection - Current Bladder stones - Bladder cancer or suspected bladder cancer - Gross Hematuria - Pregnancy or planning to become pregnant during the study - Cognitive impairment - Central or peripheral neurologic disorders such as multiple sclerosis, Parkinson's disease, spina bifida, spinal cord lesions, etc. - Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (ankle/leg) - Uncontrolled diabetes - Diabetes with peripheral nerve involvement - Current use of anticoagulants (excluding aspirin) - Current use of anticholinergics or use within the last 4 weeks - Current use of botox bladder injections or bladder botox injection within the last year (12 months) - Current use of sacral neuromodulation therapy or currently implanted sacral neuromodulation device or leads - Bladder outlet obstruction - Urinary retention or gastric retention - Painful Bladder Syndrome/Interstitial Cystitis - Unable to be contacted for follow up by telephone - Inability to speak/read/understand English or Spanish |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico |
United States,
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Matza LS, Thompson CL, Krasnow J, Brewster-Jordan J, Zyczynski T, Coyne KS. Test-retest reliability of four questionnaires for patients with overactive bladder: the overactive bladder questionnaire (OAB-q), patient perception of bladder condition (PPBC), urgency questionnaire (UQ), and the primary OAB symptom questionnaire (POSQ). Neurourol Urodyn. 2005;24(3):215-25. doi: 10.1002/nau.20110. — View Citation
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overactive bladder Questionnaire (OAB-q) Health-Related Quality of Life (HRQOL) score | Change in OAB-q HRQOL score from baseline to 12 weeks, score range 0 to 100, higher scores indicating higher quality of life (higher scores good) | 12 weeks | |
Secondary | Overactive bladder questionnaire (OAB-q) Symptom Bother subscale score | OAB-q Symptom Bother subscale score change from baseline to time point, scores ranging from 0 to 100, higher scores indicating higher bother/worse symptoms (higher scores bad) | 6 weeks, 12 weeks | |
Secondary | Overactive bladder Questionnaire (OAB-q) Health-Related Quality of Life | Change in OAB-q HRQOL score from baseline to 12 weeks, score range 0 to 100, higher scores indicating higher quality of life (higher scores good) | 6 weeks | |
Secondary | Number of urinary incontinence episodes | Number of urinary incontinence episodes on 3-day voiding diary | 6 weeks, 12 weeks | |
Secondary | Number of voids per day | Number of voids per day on 3-day voiding diary | 6 weeks, 12 weeks | |
Secondary | Number of voids per night | Number of voids per night on 3-day voiding diary | 6 weeks, 12 weeks | |
Secondary | Patient satisfaction question (PSQ) | Patient satisfaction question is a single question asking: "How satisfied are you with your progress in this program?", where patients answer on a Likert scale the possible responses of "completely", "somewhat", and "not at all". | 6 weeks, 12 weeks | |
Secondary | Patient compliance | Number of treatment sessions completed | 6 weeks, 12 weeks | |
Secondary | Adverse events | Adverse events reported during research | Weekly for 12 weeks |
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