Urinary Retention
Conditions
Keywords
Voiding dysfunction
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPTNS Active Treatment
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.
OTHERSham treatment
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
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* First voiding trial after Urogynecological surgery shows that bladder is not emptying well.
Exclusion criteria
* Patient declines participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent Retention | 30 minutes | Number of participants with persistent unsuccessful trial of void after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Improvement in Voiding Efficiency | 30 minutes | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Data - Impression of Allocation | 30 minutes | 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. |
| Pain From Treatment | 30 minutes | Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain) |
Countries
United States
Participant flow
Recruitment details
112 subjects invited to participate, 28 declined, and 84 were equally distributed between treatment and sham groups
Participants by arm
| Arm | Count |
|---|---|
| Sham Treatment No electrical stimulation is actually received
Sham treatment: No electrical stimulation is given | 42 |
| Peructaneous Tibial Nerve Stimulation Patient receives PTNS for 30 minutes
PTNS treatment: Electrical stimulation is received | 42 |
| Total | 84 |
Baseline characteristics
| Characteristic | Sham Treatment | Peructaneous Tibial Nerve Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 36 Participants | 75 Participants |
| Age, Customized | 46 years STANDARD_DEVIATION 8 | 54 years STANDARD_DEVIATION 11 | 50 years STANDARD_DEVIATION 9 |
| BMI | 29.0 kg/m2 STANDARD_DEVIATION 3.1 | 28.7 kg/m2 STANDARD_DEVIATION 3.5 | 28.9 kg/m2 STANDARD_DEVIATION 3.3 |
| Gender Female | 42 Participants | 42 Participants | 84 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Parity | 2 pregnancies STANDARD_DEVIATION 1 | 2 pregnancies STANDARD_DEVIATION 1 | 2 pregnancies STANDARD_DEVIATION 1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Persistent Retention
Number of participants with persistent unsuccessful trial of void after the intervention
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Treatment | Persistent Retention | 29 participants |
| Peructaneous Tibial Nerve Stimulation | Persistent Retention | 21 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.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Treatment | Amount of Improvement in Voiding Efficiency | 21 percentage of voided vol/total volume | Standard Deviation 8 |
| Peructaneous Tibial Nerve Stimulation | Amount of Improvement in Voiding Efficiency | 28 percentage of voided vol/total volume | Standard Deviation 5 |
Other Pre-specified
Pain From Treatment
Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain)
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Treatment | Pain From Treatment | 0.14 units on a scale | Standard Deviation 0.08 |
| Peructaneous Tibial Nerve Stimulation | Pain From Treatment | 0.55 units on a scale | Standard Deviation 0.09 |
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.
Time frame: 30 minutes
Population: Number
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham Treatment | Questionnaire Data - Impression of Allocation | 10 number of participants |
| Peructaneous Tibial Nerve Stimulation | Questionnaire Data - Impression of Allocation | 41 number of participants |