Trial Outcomes & Findings for Treatment for Acute Postoperative Voiding Dysfunction (NCT NCT01189136)

Results Overview

Number of participants with persistent unsuccessful trial of void after the intervention

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

30 minutes

Results posted on

2017-02-23

Participant Flow

112 subjects invited to participate, 28 declined, and 84 were equally distributed between treatment and sham groups

Participant milestones

Participant milestones
Measure	Sham Treatment No electrical stimulation is actually received Sham treatment: No electrical stimulation is given	Peructaneous Tibial Nerve Stimulation Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received
Overall Study STARTED	42	42
Overall Study COMPLETED	42	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment for Acute Postoperative Voiding Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Treatment n=42 Participants No electrical stimulation is actually received Sham treatment: No electrical stimulation is given	Peructaneous Tibial Nerve Stimulation n=42 Participants Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Customized	46 years STANDARD_DEVIATION 8 • n=5 Participants	54 years STANDARD_DEVIATION 11 • n=7 Participants	50 years STANDARD_DEVIATION 9 • n=5 Participants
Gender Female	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Parity	2 pregnancies STANDARD_DEVIATION 1 • n=5 Participants	2 pregnancies STANDARD_DEVIATION 1 • n=7 Participants	2 pregnancies STANDARD_DEVIATION 1 • n=5 Participants
BMI	29.0 kg/m2 STANDARD_DEVIATION 3.1 • n=5 Participants	28.7 kg/m2 STANDARD_DEVIATION 3.5 • n=7 Participants	28.9 kg/m2 STANDARD_DEVIATION 3.3 • n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Number of participants with persistent unsuccessful trial of void after the intervention

Outcome measures

Outcome measures
Measure	Sham Treatment n=42 Participants No electrical stimulation is actually received Sham treatment: No electrical stimulation is given	Peructaneous Tibial Nerve Stimulation n=42 Participants Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received
Persistent Retention	29 participants	21 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sham Treatment n=42 Participants No electrical stimulation is actually received Sham treatment: No electrical stimulation is given	Peructaneous Tibial Nerve Stimulation n=42 Participants Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received
Amount of Improvement in Voiding Efficiency	21 percentage of voided vol/total volume Standard Deviation 8	28 percentage of voided vol/total volume Standard Deviation 5

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 minutes

Population: Number

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.

Outcome measures

Outcome measures
Measure	Sham Treatment n=42 Participants No electrical stimulation is actually received Sham treatment: No electrical stimulation is given	Peructaneous Tibial Nerve Stimulation n=42 Participants Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received
Questionnaire Data - Impression of Allocation	10 number of participants	41 number of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 minutes

Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain)

Outcome measures

Outcome measures
Measure	Sham Treatment n=42 Participants No electrical stimulation is actually received Sham treatment: No electrical stimulation is given	Peructaneous Tibial Nerve Stimulation n=42 Participants Patient receives PTNS for 30 minutes PTNS treatment: Electrical stimulation is received
Pain From Treatment	0.14 units on a scale Standard Deviation 0.08	0.55 units on a scale Standard Deviation 0.09

Adverse Events

Sham Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peructaneous Tibial Nerve 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

Adverse event data not reported

Additional Information

Charles R. Rardin, MD

Women & Infants Hospital of Rhode Island

Phone: 401 453-7560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place