Trial Outcomes & Findings for Amplifying Sensation in Underactive Bladder (NCT NCT04516434)

Last Updated: 2025-07-16

Results Overview

Use of intraurethral electrical stimulation or intravesical electrical stimulation to assess increase in voided percentage during pressure-flow studies. Voiding efficiency is calculated as voided volume divided by the sum of voided volume and residual volume.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline, pressure-flow study (up to 60 minutes)

Results posted on

2025-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Intravesical Electrical Stimulation To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.
Overall Study STARTED	12	8
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Amplifying Sensation in Underactive Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravesical Electrical Stimulation n=12 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation n=8 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.	Total n=20 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 6 • n=5 Participants	67 years STANDARD_DEVIATION 4 • n=7 Participants	68 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, pressure-flow study (up to 60 minutes)

Outcome measures

Outcome measures
Measure	Intravesical Electrical Stimulation n=12 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation n=8 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.
Voiding Efficiency Baseline	32 voided percentage Standard Deviation 31	53 voided percentage Standard Deviation 22
Voiding Efficiency Pressure-flow study (up to 60 minutes)	43 voided percentage Standard Deviation 37	46 voided percentage Standard Deviation 27

PRIMARY outcome

Timeframe: baseline and post study procedures, up to 60 minutes

Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) to assess whether electrical stimulation decreases urinary bothersome symptoms and increases bladder sensation during filling and emptying. Scores range from 0 (least severe) to 100 (most severe). Higher scores indicate greater severity of lower urinary tract symptoms.

Outcome measures

Outcome measures
Measure	Intravesical Electrical Stimulation n=12 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation n=8 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.
Change in Bothersome Symptoms and Sensation Baseline	52 CASUS questionnaire scores Standard Deviation 15	53 CASUS questionnaire scores Standard Deviation 11
Change in Bothersome Symptoms and Sensation Post Study Procedures	46 CASUS questionnaire scores Standard Deviation 16	39 CASUS questionnaire scores Standard Deviation 18

SECONDARY outcome

Timeframe: CPT, up to 60 minutes

Assess bladder or urethral current perception threshold (CPT) in women with underactive bladder compared to normative values. The CPT value determined by the device is defined as the average of the minimum amplitude of the stimulus consistently detected and the stimulus 40 µA lower that was consistently not detected.

Outcome measures

Outcome measures
Measure	Intravesical Electrical Stimulation n=12 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation n=8 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.
Current Perception Threshold 5 Hz	8.57 mA (maximum amplitude) Standard Deviation 3.23	8.27 mA (maximum amplitude) Standard Deviation 3.61
Current Perception Threshold 250 Hz	9.99 mA (maximum amplitude) Standard Deviation 0.00	9.04 mA (maximum amplitude) Standard Deviation 0.40
Current Perception Threshold 2000 Hz	9.99 mA (maximum amplitude) Standard Deviation 0.00	9.99 mA (maximum amplitude) Standard Deviation 0.00

SECONDARY outcome

Timeframe: cystometry before stimulation and after stimulation (up to 60 minutes)

Use of intravesical electrical stimulation to assess volumes during cystometry. Bladder sensation and urgency assessed at volume of first sensation during bladder filling, first desire to void, strong desire to void, and maximum cystometric capacity.

Outcome measures

Outcome measures
Measure	Intravesical Electrical Stimulation n=12 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation n=8 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.
Cystometry Volume first sensation of bladder filling - before stimulation	290 mL Standard Deviation 159	253 mL Standard Deviation 122
Cystometry Volume first sensation of bladder filling - after stimulation	281 mL Standard Deviation 146	357 mL Standard Deviation 135
Cystometry Volume maximum cystometric capacity - before stimulation	517 mL Standard Deviation 263	458 mL Standard Deviation 225
Cystometry Volume maximum cystometric capacity - after stimulation	528 mL Standard Deviation 253	646 mL Standard Deviation 211

SECONDARY outcome

Timeframe: Baseline, pressure-flow study (up to 60 minutes)

Use of intraurethral electrical stimulation to assess contraction strength relative to baseline. Bladder pressure (cmH2O) is recorded over time during voiding.

Outcome measures

Outcome measures
Measure	Intravesical Electrical Stimulation n=12 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation n=8 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.
Bladder Contraction Strength Baseline	11 cmH2O Standard Deviation 32	33 cmH2O Standard Deviation 41
Bladder Contraction Strength Pressure-flow study (up to 60 minutes)	21 cmH2O Standard Deviation 18	25 cmH2O Standard Deviation 27

SECONDARY outcome

Timeframe: Baseline, pressure-flow study (up to 60 minutes)

Use of intraurethral electrical stimulation to assess flow duration during a bladder contraction relative to baseline.

Outcome measures

Outcome measures
Measure	Intravesical Electrical Stimulation n=12 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation n=8 Participants To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.
Bladder Contraction Duration Baseline	8 mL/s Standard Deviation 3	15 mL/s Standard Deviation 3
Bladder Contraction Duration Pressure-flow study (up to 60 minutes)	15 mL/s Standard Deviation 12	13 mL/s Standard Deviation 7

Adverse Events

Intravesical Electrical Stimulation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Intraurethral Electrical Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intravesical Electrical Stimulation n=12 participants at risk To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the bladder . The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the bladder (up to 60 minutes). The researchers will also place a surface patch on the participant's abdomen to disperse the electrical current and reduce discomfort.	Intraurethral Electrical Stimulation n=8 participants at risk To evaluate improvement of sensations during bladder filling and emptying with electrical stimulation to the bladder or urethra. The researchers will use the values obtained from investigational sensory testing to deliver continuous electrical stimulation to the urethra. The location depends on which value is higher compared to normal. A nurse or doctor will place a catheter with electrodes to perform this investigational study procedure to the urethra (up to 15 minutes). Two surface patches (electrodes) will be placed at the 3 o'clock and 9 o'clock positions, 1 to 3 centimeters from the around the vaginal opening. These electronic sensors will record muscle activity while the bladder is contracting. The intraurethral stimulation will occur during routine urodynamic evaluation when the participant urinates on a special toilet.
Renal and urinary disorders Urinary tract infection	25.0% 3/12 • One month post study completion	0.00% 0/8 • One month post study completion

Additional Information

Cindy Amundsen, MD

Duke University Medical Center

Phone: 919-401-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place