Overactive Bladder Syndrome, Urinary Incontinence, Urge
Conditions
Keywords
overactive bladder, OAB, urge urinary incontinence, PTNS
Brief summary
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
Detailed description
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
Interventions
DEVICEPTNS
Use of PTNS on the ankle for 30 minutes
Sponsors
Gnankang Sarah Napoe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy 2. Patients who consent to participate in the study 3. Patients on pharmacologic therapy at the time of recruitment can continue their treatment
Exclusion criteria
1. Pregnant patients 2. Patients with pacemakers of implantable defibrillators 3. Patients with neurogenic bladder 4. Patients who have received Botox or have an implant for sacral nerve stimulation 5. Patients with uncontrolled bleeding disorder 6. Patients with unhealed ulcers or with leg edema surrounding medial malleolus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement | 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. |
| Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement | 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. |
| Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement | 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. |
| Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unilateral PTNS PTNS: Use of PTNS on the ankle for 30 minutes | 18 |
| Bilateral PTNS PTNS: Use of PTNS on both ankles for 30 minutes | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Bilateral PTNS | Total | Unilateral PTNS |
|---|---|---|---|
| Age, Customized Age | 69.4 years STANDARD_DEVIATION 11.4 | 68.7 years STANDARD_DEVIATION 12.5 | 68.1 years STANDARD_DEVIATION 13.8 |
| Daily Incontinence Episodes | 2.6 Incontinence episodes STANDARD_DEVIATION 2 | 2.5 Incontinence episodes STANDARD_DEVIATION 2.2 | 2.3 Incontinence episodes STANDARD_DEVIATION 2.4 |
| Daily voids | 9.6 Daily voids STANDARD_DEVIATION 4.1 | 9.7 Daily voids STANDARD_DEVIATION 3.7 | 9.8 Daily voids STANDARD_DEVIATION 3.2 |
| History of Diabetes mellitus | 7 participants | 9 participants | 2 participants |
| Incontinence Impact Questionnaire (IIQ) Score | 59.8 units on a scale STANDARD_DEVIATION 23.6 | 54.8 units on a scale STANDARD_DEVIATION 26.9 | 49.5 units on a scale STANDARD_DEVIATION 29.7 |
| Nocturia Episodes | 1.7 Nocturia episodes STANDARD_DEVIATION 1.9 | 1.7 Nocturia episodes STANDARD_DEVIATION 1.6 | 1.7 Nocturia episodes STANDARD_DEVIATION 1.4 |
| On Overactive bladder (OAB) Medications | 4 participants | 10 participants | 6 participants |
| Overactive bladder questionnaire short form (OABq SF) Score | 56.1 units on a scale STANDARD_DEVIATION 26.2 | 60.4 units on a scale STANDARD_DEVIATION 24.1 | 64.6 units on a scale STANDARD_DEVIATION 21.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 18 Participants | 36 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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.
Time frame: 12 weeks or last measurement
Population: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement | -17.8 score on a scale | Standard Deviation 24.7 |
| Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in Overactive Bladder Questionnaire Score From Baseline to 12 Weeks or Last Measurement | -23.5 score on a scale | Standard Deviation 29.3 |
p-value: 0.546Pairwise t- test
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.
Time frame: 12 weeks or last measurement
Population: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement | -0.2 Number of daytime voids | Standard Deviation 3.3 |
| Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in Daily Number of Voids From Baseline to 12 Weeks or Last Measurement | -1.3 Number of daytime voids | Standard Deviation 2.6 |
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.
Time frame: 12 weeks or last measurement
Population: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement | -0.1 Number of nighttime voids | Standard Deviation 1.1 |
| Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in Nocturia Episodes From Baseline to 12 Weeks or Last Measurement | -0.8 Number of nighttime voids | Standard Deviation 1.4 |
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.
Time frame: 12 weeks or last measurement
Population: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement | -0.3 Number of incontinence episodes | Standard Deviation 3.6 |
| Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Change in Number of Incontinence Episodes Per 24 Hours From Baseline to 12 Weeks or Last Measurement | -1.2 Number of incontinence episodes | Standard Deviation 1.3 |
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.
Time frame: 12 weeks or last measurement
Population: Analysis was performed on all enrolled participants data available even if the participant withdrew from study prior to completion of study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement | -12.8 score on a scale | Standard Deviation 24.7 |
| Bilateral PTNS Change in Overactive Bladder Questionnaire Short Form Score | Impact of Treatment on Quality of Life From Baseline to 12 Weeks or Last Measurement | -19.3 score on a scale | Standard Deviation 18.9 |