Trial Outcomes & Findings for Systematized Quality Exercise Alternatives for Stress Incontinence (NCT NCT03443687)

NCT ID: NCT03443687

Last Updated: 2023-12-21

Results Overview

Scale is International Consultation Incontinence Questionnaire short form (ICIQ-SF). Minimum is 0 and Maximum is 21. A higher score indicates greater impairment from incontinence.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-12-21

Participant Flow

Participant milestones

Measure	Pelvic Floor Physical Therapy If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires. Pelvic Floor Physical Therapy: Pelvic floor exercises for 3 months under instruction of physical therapist	Home Biofeedback If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires. Home Biofeedback: Pelvic floor exercises for 3 months using biofeedback device
Overall Study STARTED	27	27
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Pelvic Floor Physical Therapy If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires. Pelvic Floor Physical Therapy: Pelvic floor exercises for 3 months under instruction of physical therapist	Home Biofeedback If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires. Home Biofeedback: Pelvic floor exercises for 3 months using biofeedback device
Overall Study Lost to Follow-up	3	5
Overall Study Withdrawal by Subject	1	0
Overall Study Discontinued intervention	1	1

Baseline Characteristics

Systematized Quality Exercise Alternatives for Stress Incontinence

Baseline characteristics by cohort

Measure	Pelvic Floor Physical Therapy n=27 Participants If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires. Pelvic Floor Physical Therapy: Pelvic floor exercises for 3 months under instruction of physical therapist	Home Biofeedback n=27 Participants If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires. Home Biofeedback: Pelvic floor exercises for 3 months using biofeedback device	Total n=54 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 13 • n=5 Participants	44 years STANDARD_DEVIATION 10 • n=7 Participants	46 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Scale is International Consultation Incontinence Questionnaire short form (ICIQ-SF). Minimum is 0 and Maximum is 21. A higher score indicates greater impairment from incontinence.

Outcome measures

Measure	Pelvic Floor Physical Therapy n=22 Participants If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires. Pelvic Floor Physical Therapy: Pelvic floor exercises for 3 months under instruction of physical therapist	Home Biofeedback n=21 Participants If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires. Home Biofeedback: Pelvic floor exercises for 3 months using biofeedback device
Change in Quality of Life	4.73 score on a scale Interval 3.21 to 6.25	3.95 score on a scale Interval 2.21 to 5.7

SECONDARY outcome

Timeframe: 3 Months

Female sexual index will be used to assess change in sexual function over study. Female sexual function index (FSFI) questionnaire and Pelvic organ prolapse incontinence sexual questionnaire were PI developed questionnaires. The minimum is 0 and the maximum is 36. A higher score indicates greater sexual impairment.

Outcome measures

Measure	Pelvic Floor Physical Therapy n=22 Participants If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires. Pelvic Floor Physical Therapy: Pelvic floor exercises for 3 months under instruction of physical therapist	Home Biofeedback n=21 Participants If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires. Home Biofeedback: Pelvic floor exercises for 3 months using biofeedback device
Sexual Function	0.42 score on a scale Interval 0.0 to 36.0	1.81 score on a scale Interval 0.0 to 36.0

Adverse Events

Pelvic Floor Physical Therapy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Home Biofeedback

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pelvic Floor Physical Therapy n=27 participants at risk If randomized to this arm, women will complete demographic forms and questionnaires. They will then undergo the intervention of 4 pelvic floor physical therapy visits over 3 months. At that time they will return for a follow up visit and complete questionnaires. Pelvic Floor Physical Therapy: Pelvic floor exercises for 3 months under instruction of physical therapist	Home Biofeedback n=27 participants at risk If randomized to this arm, women will complete demographic forms and questionnaires. They will then be given a pelvic floor exercise device that is bluetooth linked to a smartphone application. They will be instructed on how to use the device daily for 3 months and their intervention will be to perform daily exercises with the device in place. At 3 months they will return for a follow up visit and complete questionnaires. Home Biofeedback: Pelvic floor exercises for 3 months using biofeedback device
Infections and infestations infection	7.4% 2/27 • Number of events 2 • 3 months	0.00% 0/27 • 3 months
Infections and infestations vaginal infection	3.7% 1/27 • Number of events 1 • 3 months	3.7% 1/27 • Number of events 1 • 3 months
Infections and infestations Vaginal discharge without infection	3.7% 1/27 • Number of events 1 • 3 months	0.00% 0/27 • 3 months

Additional Information

Dr. Gena Dunivan

University of New Mexico, Dept OBGYN

Phone: 5052729712

Email: gdunivan@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place