Trial · NCT04907032
Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)
NCT04907032, Phase 4, Completed, University of Alabama at Birmingham; results first posted 2023-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study). Trials, record NCT04907032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04907032
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)
- NCT number
- NCT04907032
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 54 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Overactive Bladder
- Interventions
- Mirabegron 50 MG, Posterior Tibial Nerve Stimulation (PTNS)
- First posted
- 2021-05-28
- Last updated
- 2023-07-20
- Results first posted
- 2023-07-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks | 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 | change in the number of urgency urinary incontinence episodes as measures by a 3-day voiding diary pre- vs. post-treatment. This includes a baseline measure pre-trial and then a post-trial measure in 12 weeks and then you calculate the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. |
| Secondary | Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) | 12 weeks | This is a quality of life measure using a validated questionnaire called the Urinary Distress Index Scale with a range from 0-100 with higher scores meaning worse urinary distress such as urinary incontinence and leakage and bother with the life stresses related to urinary incontinence. Will include a baseline measure pre-trial and then a post-trial measure (post-trial). This includes a pre-trial measure (baseline) and a post-trial measure and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. |
| Secondary | Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks) | pre-trial 0-100 scale measurement and then 12 weeks later post-trial measurement 0-100 with higher scores meaning worse impact. | The IIQ-7 (Incontinence Impact Questionnaire) is a measure of distress caused by urge urinary incontinence and overactive bladder in the patient. This scale is a scale of 0-100 with 0 being minimal impact and 100 being worse impact and distress. This includes a baseline pre-trial measure and a post-trial measure at 12 weeks. This includes a pre-trial measure (baseline) and then a post-trial measure and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. |
| Secondary | Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) | pre trial measurements as described and then 12 weeks later post-trial measurements as described. | This is the change in Quality of life measure for urge urinary incontinence for the OABq SF scale and it is a 0-100 scale where 0 equals minimum symptoms and 100 equals maximal symptoms. Lower scores indicate better quality of life and higher scores indicate worse quality of life. This includes a pre-trial measure and a post-trial measure at 12 weeks and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks | 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 | UUI episodes | MEAN | |
| SECONDARY | Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) | 12 weeks | score on a scale | MEAN | |
| SECONDARY | Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks) | pre-trial 0-100 scale measurement and then 12 weeks later post-trial measurement 0-100 with higher scores meaning worse impact. | score on a scale | MEAN | |
| SECONDARY | Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) | pre trial measurements as described and then 12 weeks later post-trial measurements as described. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks | Posterior Tibial Nerve Stimulation With Mirabegron | 9.4 | Standard Deviation 3.9 | UUI episodes | |
| Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks | Posterior Tibial Nerve Stimulation Plus Placebo | 5.3 | Standard Deviation 5.4 | UUI episodes | |
| Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) | Posterior Tibial Nerve Stimulation With Mirabegron | 23.6 | Standard Deviation 12.9 | score on a scale | |
| Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) | Posterior Tibial Nerve Stimulation Plus Placebo | 16.3 | Standard Deviation 14.0 | score on a scale | |
Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks) | Posterior Tibial Nerve Stimulation With Mirabegron | 29.7 | Standard Deviation 17.4 | score on a scale | |
Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks) | Posterior Tibial Nerve Stimulation Plus Placebo | 20.2 | Standard Deviation 17.6 | score on a scale | |
Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) | Posterior Tibial Nerve Stimulation With Mirabegron | 53.6 | Standard Deviation 30.0 | score on a scale | |
Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) | Posterior Tibial Nerve Stimulation Plus Placebo | 33.3 | Standard Deviation 35.7 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Posterior Tibial Nerve Stimulation With Mirabegron | 27 | |
| Overall Study | STARTED | Posterior Tibial Nerve Stimulation Plus Placebo | 27 | |
| Overall Study | COMPLETED | Posterior Tibial Nerve Stimulation With Mirabegron | 20 | |
| Overall Study | COMPLETED | Posterior Tibial Nerve Stimulation Plus Placebo | 26 | |
| Overall Study | NOT COMPLETED | Posterior Tibial Nerve Stimulation With Mirabegron | 7 | |
| Overall Study | NOT COMPLETED | Posterior Tibial Nerve Stimulation Plus Placebo | 1 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary Tract Infection | General disorders | Posterior Tibial Nerve Stimulation With Mirabegron | 3 | 27 | 3 |
| other | Urinary Tract Infection | General disorders | Posterior Tibial Nerve Stimulation Plus Placebo | 3 | 27 | 3 |
| other | transient leg swelling from PTNS | Musculoskeletal and connective tissue disorders | Posterior Tibial Nerve Stimulation With Mirabegron | 3 | 27 | 3 |
| other | transient leg swelling from PTNS | Musculoskeletal and connective tissue disorders | Posterior Tibial Nerve Stimulation Plus Placebo | 3 | 27 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Posterior Tibial Nerve Stimulation With Mirabegron | 0 | 27 |
| Total, all-cause mortality | Posterior Tibial Nerve Stimulation Plus Placebo | 0 | 27 |
| Total, other adverse events | Posterior Tibial Nerve Stimulation With Mirabegron | 6 | 27 |
| Total, other adverse events | Posterior Tibial Nerve Stimulation Plus Placebo | 6 | 27 |
| Total, serious adverse events | Posterior Tibial Nerve Stimulation With Mirabegron | 0 | 27 |
| Total, serious adverse events | Posterior Tibial Nerve Stimulation Plus Placebo | 0 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39101958 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Posterior Tibial Nerve Stimulation With Mirabegron vs Posterior Tibial Nerve Stimulation Plus Placebo: deaths from any cause | Trial comparisons |
| Posterior Tibial Nerve Stimulation With Mirabegron vs Posterior Tibial Nerve Stimulation Plus Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04907032
GET https://conductscience.org/api/trials/v1/NCT04907032/registered