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Challenges with recruitment
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This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence
Percutaneous tibial nerve stimulation (PTNS) is an accepted treatment for overactive bladder that can be accomplished in the office with minimal side effects. It is currently carried out by stimulating one of the posterior tibial nerves unilaterally. The aim of this study is to determine whether bilateral percutaneous tibial nerve stimulation is more effective than unilateral stimulation. Patients with a diagnosis of overactive bladder who have previously failed lifestyle changes and/or pharmacologic therapy will be offered percutaneous tibial nerve stimulation. Enrolled patients will be randomized into two groups. The control group will receive the traditional unilateral treatment of PTNS. The intervention group will receive bilateral PTNS treatment. Intervention success will be measured by improvement in overactive bladder symptoms assessed by improvement in the scores on the overactive bladder questionnaire symptoms bother and decrease in number of voids, nocturia episodes and incontinence episodes as reported in the voiding diary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral PTNS | Active Comparator | 34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period |
|
| Bilateral PTNS | Experimental | 34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTNS | Device | Use of PTNS on the ankle for 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement | Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores. The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation. | 12 weeks or last measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement | The change in number of voids was obtained by comparing number of voids at 12 weeks or last measurement compared to baseline number of voids. | 12 weeks or last measurement |
| Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G. Sarah Napoe, MD | University of Pittsburgh | Principal Investigator |
| Kyle Wohlrab, MD | Women and Infants Hospital of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gnankang Sarah Napoe | Pittsburgh | Pennsylvania | 15203 | United States | ||
| WIHRI |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41342952 | Derived | Napoe GS, Hall E, Dasgupta P, Myers DL, Wohlrab KJ. Randomized trial of unilateral versus bilateral percutaneous tibial nerve stimulation for the treatment of overactive bladder. World J Urol. 2025 Dec 4;44(1):15. doi: 10.1007/s00345-025-06107-0. |
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No plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Unilateral PTNS | 34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period PTNS: Use of PTNS on the ankle for 30 minutes |
| FG001 | Bilateral PTNS | 34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period PTNS: Use of PTNS on the ankle for 30 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unilateral PTNS | PTNS: Use of PTNS on the ankle for 30 minutes |
| BG001 | Bilateral PTNS | PTNS: Use of PTNS on both ankles for 30 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement | Overactive Bladder questionnaire short form (OABqSF) symptom severity questionnaire was administered at baseline, 4 weeks, 8 weeks then 12 weeks. The OABqSF score ranges from 0 to 100. Those with more bothersome symptoms have higher scores. The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation. | Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks or last measurement |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unilateral PTNS | One ankle stimulation | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr, Gnankang Sarah Napoe | University of Pittsburgh | 412-641-7850 | napoegs@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2024 | Feb 7, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes. |
| 12 weeks or last measurement |
| Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement | Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids. | 12 weeks or last measurement |
| Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement | The incontinence impact questionnaire was used to measure the impact on quality of life. The questionnaire score ranges from 0 to 100 with higher scores indicating worse quality of life. | 12 weeks or last measurement |
| Providence |
| Rhode Island |
| 02905 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| On Overactive bladder (OAB) Medications | Number | participants |
|
| History of Diabetes mellitus | Number | participants |
|
| Overactive bladder questionnaire short form (OABq SF) Score | Missing data | Mean | Standard Deviation | units on a scale |
|
| Incontinence Impact Questionnaire (IIQ) Score | Missing data | Mean | Standard Deviation | units on a scale |
|
| Daily Incontinence Episodes | Missing data | Mean | Standard Deviation | Incontinence episodes |
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| Nocturia Episodes | Missing data | Mean | Standard Deviation | Nocturia episodes |
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| Daily voids | Missing data | Mean | Standard Deviation | Daily voids |
|
| OG001 | Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in overactive bladder symptom severity was measured by comparing last overactive bladder questionnaire score to overactive bladder questionnaire score at baseline for two ankle stimulation |
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| Secondary | Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement | The change in number of voids was obtained by comparing number of voids at 12 weeks or last measurement compared to baseline number of voids. | Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study. | Posted | Mean | Standard Deviation | Number of daytime voids | 12 weeks or last measurement |
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|
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| Secondary | Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement | Change in number of incontinence episodes defined as number of incontinence episodes at completion of PTNS (12 weeks or last measurement) compared to baseline number of incontinence episodes. | Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study. | Posted | Mean | Standard Deviation | Number of incontinence episodes | 12 weeks or last measurement |
|
|
|
| Secondary | Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement | Change in number of nocturia episodes defined as number of nighttime voids at completion of PTNS (12 weeks or last measurement) compared to baseline number of nighttime voids. | Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study. | Posted | Mean | Standard Deviation | Number of nighttime voids | 12 weeks or last measurement |
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| Secondary | Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement | The incontinence impact questionnaire was used to measure the impact on quality of life. The questionnaire score ranges from 0 to 100 with higher scores indicating worse quality of life. | Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks or last measurement |
|
|
|
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Bilateral PTNS | Two ankle stimulation | 0 | 18 | 0 | 18 | 0 | 18 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |