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| ID | Type | Description | Link |
|---|---|---|---|
| 06-0061 | Other Identifier | WIHRI |
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If patients are unable to have their foley catheter removed because their bladder is not emptying well, they may be eligible for study participation. This study is designed to evaluate whether Posterior Tibial Nerve Stimulation is effective in improving bladdder function after surgery. Study participation is limited to one day.
If patients fail a voiding trial (the test done to see if a foley catheter is ready to be removed after surgery), they may be offered participation in this trial. Patients are randomized to receive active treatment or a sham treatment. A small, accupuncture-type needle is inserted through the skin just above the ankle. A small, battery-powered generator will be attached to the needle. The generator will give a low-voltabe stimulation which is adjusted for comfort level and applied for 30 minutes. After treatemnt, the voiding trial will be repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham treatment | Sham Comparator | 34 gauge needle inserted 3cm above the medial ankle, but nonconductive cables are connected, so that no electrical stimulation is applied, over a 30-minute treatment period |
|
| PTNS Active Treatment | Experimental | 34 gauge needle inserted 3cm above the medial ankle, 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 Active Treatment | Device | 34 gauge needle inserted 3cm above the medial ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent Retention | Number of participants with persistent unsuccessful trial of void after the intervention | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Improvement in Voiding Efficiency | Improvement of voiding efficiency, as measured by dividing the volume voided by the total volume (voided volume + retained volume) per participant. Each participant is evaluated separately, and the mean percentage of improvement was calculated for each arm. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire Data - Impression of Allocation | Participants were asked to guess to which treatment arm they had been allocated ("PTNS" "Sham" or "I Don't Know"). Outcome was measured as the number of patients in each arm accurately determining their allocation. | 30 minutes |
| Pain From Treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles R Rardin, MD | Women and Infants Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
No plans to make IPD available
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112 subjects invited to participate, 28 declined, and 84 were equally distributed between treatment and sham groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Treatment | No electrical stimulation is actually received Sham treatment: No electrical stimulation is given |
| FG001 | Peructaneous Tibial Nerve Stimulation | Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Treatment | No electrical stimulation is actually received Sham treatment: No electrical stimulation is given |
| BG001 | Peructaneous Tibial Nerve Stimulation | Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Persistent Retention | Number of participants with persistent unsuccessful trial of void after the intervention | Posted | Number | participants | 30 minutes |
|
|
1 hour (30 minutes of treatment, then 30 minutes of observation prior to hospital discharge)
Any adverse events were collected by the investigators.
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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 | Sham Treatment | No electrical stimulation is actually received Sham treatment: No electrical stimulation is given |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles R. Rardin, MD | Women & Infants Hospital of Rhode Island | 401 453-7560 | crardin@wihri.org |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Sham treatment | Other | 34 gauge needle inserted 3cm above the medial ankle, but nonconductive cables are connected, so that no electrical stimulation is applied, over a 30-minute treatment period |
|
Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain) |
| 30 minutes |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Customized | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Parity | Mean | Standard Deviation | pregnancies |
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| BMI | Mean | Standard Deviation | kg/m2 |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Amount of Improvement in Voiding Efficiency | Improvement of voiding efficiency, as measured by dividing the volume voided by the total volume (voided volume + retained volume) per participant. Each participant is evaluated separately, and the mean percentage of improvement was calculated for each arm. | Posted | Mean | Standard Deviation | percentage of voided vol/total volume | 30 minutes |
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|
|
| Other Pre-specified | Questionnaire Data - Impression of Allocation | Participants were asked to guess to which treatment arm they had been allocated ("PTNS" "Sham" or "I Don't Know"). Outcome was measured as the number of patients in each arm accurately determining their allocation. | Number | Posted | Number | number of participants | 30 minutes |
|
|
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| Other Pre-specified | Pain From Treatment | Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Peructaneous Tibial Nerve Stimulation | Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received | 0 | 42 | 0 | 42 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |