Trial Outcomes & Findings for Hypnotherapy for Treatment of Overactive Bladder (NCT NCT00793611)

Results Overview

Scale information; Score ranges for oab-qsf quality of life scores range from 13-78; 13=poor quality of life 78=good quality of life. We reported change scores, with larger negative numbers indicating greater improvement in quality of life scores.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

baseline and approximately 6-12 weeks after study initiation

Results posted on

2017-10-09

Participant Flow

Patients recruited from the Clinic. Study received IRB approval winter 2008 and recruitment occurred 2008-10.

Participant milestones

Participant milestones
Measure	Behavioral Therapy Standard Care received 3 behavioral therapy session	Hypnotherapy received 3 sessions of behavioral therapy combined with hypnotherapy
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hypnotherapy for Treatment of Overactive Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Therapy Standard Care n=10 Participants received 3 behavioral therapy session	Hypnotherapy n=10 Participants received 3 sessions of behavioral therapy combined with hypnotherapy	Total n=20 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 7.4 • n=5 Participants	51.1 years STANDARD_DEVIATION 14 • n=7 Participants	54 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 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
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and approximately 6-12 weeks after study initiation

Population: ITT

Scale information; Score ranges for oab-qsf quality of life scores range from 13-78; 13=poor quality of life 78=good quality of life. We reported change scores, with larger negative numbers indicating greater improvement in quality of life scores.

Outcome measures

Outcome measures
Measure	Behavioral Therapy Standard Care n=10 Participants received 3 behavioral therapy session	Hypnotherapy n=10 Participants received 3 sessions of behavioral therapy combined with hypnotherapy
Change in Overactive Bladder Symptoms (Based on OABqSF)	-19 units on a scale Standard Deviation 24.9	-33.4 units on a scale Standard Deviation 15.2

SECONDARY outcome

Timeframe: baseline and 6-12 weeks after study initiation

Population: ITT change in mean number of voids/24 hours

change in mean number of voids per 24 hours. Each participant recorded voiding frequency every 24 hours for 3 days at baseline and follow-up. A mean number of voids for every patient over 24 hours was calculated at baseline and follow-up.

Outcome measures

Outcome measures
Measure	Behavioral Therapy Standard Care n=10 Participants received 3 behavioral therapy session	Hypnotherapy n=10 Participants received 3 sessions of behavioral therapy combined with hypnotherapy
Change in Voiding Frequency Based on Voiding Diary	1.4 number of voids per 24 hours Standard Deviation 1.4	2.6 number of voids per 24 hours Standard Deviation 2.0

SECONDARY outcome

Timeframe: 6-12 weeks after study initiation (@ completion of intervention)

Population: ITT

Outcome measure is only administered at follow-up and used following treatment in patients with urinary incontinence. Measure varies from 1 to 7 on a Likert scale. 1=very much better and 7=very much worse and 4=no change. Thus, lower numbers represent greater improvement.

Outcome measures

Outcome measures
Measure	Behavioral Therapy Standard Care n=10 Participants received 3 behavioral therapy session	Hypnotherapy n=10 Participants received 3 sessions of behavioral therapy combined with hypnotherapy
Patient Global Impression of Improvement	3.4 units on a scale Standard Deviation .97	2.15 units on a scale Standard Deviation .3

Adverse Events

Behavioral Therapy Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypnotherapy

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

Yuko Komesu MD

University of New Mexico Health Sciences Center and CTSC

Phone: 505-925-4395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place