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Trial record 70 of 272 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation

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ClinicalTrials.gov Identifier: NCT03547518
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kenneth M Peters, MD, William Beaumont Hospitals

Brief Summary:
The aim of this study is to determine the efficacy of an accelerated course for percutaneous tibial nerve stimulation (PTNS) induction to treat overactive bladder symptoms. The standard 12 weekly induction treatments may be a patient burden and a more rapid induction may speed up symptomatic improvement.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: PTNS treatment Device: Sham treatment Not Applicable

Detailed Description:
Overactive bladder (OAB) is a common condition with a prevalence ranging from 5.9% to 16.9% in the United States and has been found to increase with age. OAB has a negative impact on health related quality of life (QoL), Per American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines, PTNS is a third line recommendation for OAB along with onabotulinumtoxinA (BTX) injection and sacral neuromodulation. In the single sham-controlled trial (SUmiT: n=220), Peters et al reported that 54.5% of PTNS subjects had moderately or markedly improved bladder symptoms on global response assessments (GRA) compared to 20.9% of sham subjects (p <0.001). PTNS subjects also had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urge urinary incontinence (UUI) episodes compared to sham. There is also early data from an implanted chronic tibial nerve stimulation lead study that shows a minimum of 8 hours of tibial nerve stimulation a day results in significant improvement in incontinence episodes per day at one week. Our study will test the concept of whether the PTNS effect is dose (total time of treatment) sensitive, and whether expanding the dosage of each treatment, i.e. from 30 minutes to 2 hours, will provide significant clinical improvement after a one week induction course.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, single blind parallel assignment
Masking: Single (Participant)
Masking Description: Participant blinded to interventional or sham treatment
Primary Purpose: Treatment
Official Title: Sham Controlled Trial of Rapid Induction Percutaneous Tibial Nerve Stimulation
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : May 23, 2020
Estimated Study Completion Date : May 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active PTNS treatment
One-week induction consisting of three active PTNS treatments, each 2 hours long
Device: PTNS treatment
One-week induction consisting of three active PTNS treatments, each 2 hours long
Other Name: Urgent PC Neuromodulation System

Sham Comparator: Sham treatment
One-week induction consisting of three sham treatments, each 2 hours long
Device: Sham treatment
One-week induction consisting of three active PTNS treatments, each 2 hours long
Other Name: Simulated treatment




Primary Outcome Measures :
  1. Improvement in GRA for Overall Bladder Symptoms [ Time Frame: One week post induction (+/- 3 days) ]
    Proportion of subjects reporting "Moderately" or "Markedly Improved" responses on the GRA after 3 interventions


Secondary Outcome Measures :
  1. Change from baseline urinary frequency in 3 day voiding diary [ Time Frame: One week post induction (+/- 3 days) ]
    Change in number of total voids in three days, between pre-induction diary and post-induction diary

  2. Change from baseline nocturia in 3 day voiding diary [ Time Frame: One week post induction (+/- 3 days) ]
    Change in number of total night time urinary voids in three days, between pre-induction diary and post-induction diary

  3. Change from baseline in degree of urgency in 3 day voiding diary [ Time Frame: One week post induction (+/- 3 days) ]
    Change in number of urinary voids recorded as urgent in three days, between pre-induction diary and post-induction diary

  4. Change from baseline in number of urge incontinent episodes in 3 day voiding diary [ Time Frame: One week post induction (+/- 3 days) ]
    Change in number of urge incontinent episodes in three days, between pre-induction diary and post-induction diary

  5. Change from baseline in Overactive bladder questionnaire-short form symptom bother (OABq-SR) [ Time Frame: One week post induction (+/- 3 days) ]
    Change from baseline in summary score, total number of points on a 6 question survey of extent of how much patients were bothered by bladder symptoms, with each question rated on a 6 point likert scale with 1= Not at all and 6= a very great deal



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women and men > 18 years of age
  • Self-reported failed conservative care of behavioral modifications and/or oral medications
  • An above normal urinary frequency as recorded on initial 3-day voiding diary
  • Self-reported bladder symptoms greater than or equal to 3 months
  • On a stable dose of antimuscarinics/beta-3 agonists for greater than or equal to 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for greater than or equal to 2 weeks
  • Capable of giving informed consent
  • Ambulatory and able to use toilet independently without difficulty
  • Capable and willing to follow all study-related procedures

Exclusion Criteria:

  • Pregnant or planning to become pregnant during study duration
  • Diagnosis of neurogenic bladder
  • Botox use in bladder or pelvic floor muscles within past 12 months
  • Pacemakers or implantable defibrillators
  • Current urinary tract infection
  • Active use of neuromodulation in any other form. If patient has InterStim, must be turned off for 2 weeks for a washout period and remain off during the entirety of the study.
  • Current use of Transcutaneous Electrical Nerve Stimulation (TENS) in pelvic region, back or legs
  • Previous PTNS treatment who received greater than 6 treatments. Those who have received less than 6 treatments will be allowed to screen if the last treatment was at least 6 months prior to screening.
  • Use of investigational drug/device therapy within past 4 weeks
  • Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks
  • Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results

Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547518


Contacts
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Contact: Deborah Hasenau, MS 248 551-0804 Deborah.Hasenau@beaumont.org
Contact: Angela Waldvogel, BSN 248 551-2572 angela.waldvogel@beaumont.org

Locations
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United States, Michigan
William Beaumont Hospitals Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Amanda Schonhoff, BSN    248-551-1225    amanda.schonhoff@beaumont.org   
Contact: Angela Waldvogel, BSN    248 551-2572    angela.waldvogel@beaumont.org   
Principal Investigator: Kenneth Peters, MD         
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals

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Responsible Party: Kenneth M Peters, MD, Professor and Chairman, Department of Urology, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT03547518     History of Changes
Other Study ID Numbers: 2017-497
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Kenneth M Peters, MD, William Beaumont Hospitals:
Urinary Urgency
Urinary Frequency
Urge Incontinence

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms