Posterior Tibial Nerve Stimulation (PTNS) for Overactive Bladder

University of Alabama at Birmingham, Birmingham, AL
Overactive BladderPosterior Tibial Nerve Stimulation (PTNS) - Device
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether a combination of two treatments for urinary incontinence (PTNS and mirabegron) is better than either treatment alone. The primary outcome measure is the number of urinary incontinence episodes over a 12-week treatment course.

Eligible Conditions
  • Overactive Bladder

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Similar Trials

2
Behavioral therapy
1
Cimetidine
2
Mirabegron

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 3 day voiding diary will be filled out prior to the 12 week PTNS trial and voiding diary will be filled out immediately after the 12 week PTNS trial

12 weeks
Change in UUI/OAB quality of life as measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) questionnaire pre- vs. post-treatment
Change in UUI/OAB quality of life as measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) questionnaire pre- vs. post-treatment
Urine
Week 12
Change in the number of UUI episodes over a 3-day voiding diary pre- vs. post-treatment.

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

3
Behavioral therapy
2
Cimetidine
3
Mirabegron

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

Posterior Tibial Nerve Stimulation with Mirabegron
1 of 2
Posterior Tibial Nerve Stimulation Plus Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

54 Total Participants · 2 Treatment Groups

Primary Treatment: Posterior Tibial Nerve Stimulation (PTNS) · Has Placebo Group · Phase 4

Posterior Tibial Nerve Stimulation with MirabegronExperimental Group · 2 Interventions: Posterior Tibial Nerve Stimulation (PTNS), Mirabegron 50 MG · Intervention Types: Device, Drug
Posterior Tibial Nerve Stimulation Plus Placebo
Device
PlaceboComparator Group · 1 Intervention: Posterior Tibial Nerve Stimulation (PTNS) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 day voiding diary will be filled out prior to the 12 week ptns trial and voiding diary will be filled out immediately after the 12 week ptns trial

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,472 Previous Clinical Trials
2,246,015 Total Patients Enrolled
Russell F Stanley, DOPrincipal InvestigatorUniversity of Alabama at Birmingham

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women above 18 years old who suffer from urinary incontinence and have tried two different treatments without success.
References

Frequently Asked Questions

Is Posterior Tibial Nerve Stimulation (PTNS) effective without posing any potential risks to patients?

"The team at Power assigned a score of 3 to the safety rating for Posterior Tibial Nerve Stimulation (PTNS) as it has been approved by Phase 4 trials, which are indicative of extensive efficacy and safety data." - Anonymous Online Contributor

Unverified Answer

Are any new applicants being welcomed at the moment?

"Affirmative. Evidence on clinicaltrials.gov reveals that this experiment, first advertised on October 1st 2021, is actively seeking participants. 54 individuals are needed to be sourced from one centre for the trial's successful completion." - Anonymous Online Contributor

Unverified Answer

How many participants is the clinical trial accommodating?

"Correct. The clinicaltrials.gov website confirms that this medical study, which was originally posted on October 1st 2021, is currently recruiting participants. Approximately 54 volunteers are needed to be recruited from a single research facility." - Anonymous Online Contributor

Unverified Answer

Could you provide me with a synopsis of the research conducted on Posterior Tibial Nerve Stimulation (PTNS)?

"Currently, 11 clinical studies are underway to assess the effects of Posterior Tibial Nerve Stimulation (PTNS), with 2 trials in Phase 3. There are 58 different sites across Marseille Teugbyeolsi and Seoul facilitating these research efforts." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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