Trial Outcomes & Findings for Cystic Fibrosis and Urinary Incontinence (NCT NCT04922255)

Last Updated: 2024-10-01

Results Overview

The Patient Global Impression of Improvement-Incontinence (PGI-I) is a validated one question measure rating their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse). It is a score calculated at Day 7.

Recruitment status

TERMINATED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

7 days

Results posted on

2024-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Disposable Urethral Support Device disposable urethral support device Disposable urethral support: The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)	Reusable Underwear Reusable Underwear Reusable Underwear: Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection	Pelvic Floor Muscle Therapy (PFMT) Pelvic floor muscle therapy Pelvic floor physical therapy: Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.
Overall Study STARTED	4	6	5
Overall Study COMPLETED	4	4	4
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cystic Fibrosis and Urinary Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Disposable Urethral Support Device n=4 Participants disposable urethral support device Disposable urethral support: The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)	Reusable Underwear n=6 Participants Reusable Underwear Reusable Underwear: Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection	Pelvic Floor Muscle Therapy (PFMT) n=5 Participants Pelvic floor muscle therapy Pelvic floor physical therapy: Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.	Total n=15 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	35.7 years STANDARD_DEVIATION 10.7 • n=5 Participants	42.6 years STANDARD_DEVIATION 17.9 • n=7 Participants	34.8 years STANDARD_DEVIATION 16.7 • n=5 Participants	37.3 years STANDARD_DEVIATION 15.9 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure	Disposable Urethral Support Device n=4 Participants disposable urethral support device Disposable urethral support: The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)	Reusable Underwear n=4 Participants Reusable Underwear Reusable Underwear: Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection	Pelvic Floor Muscle Therapy (PFMT) n=4 Participants Pelvic floor muscle therapy Pelvic floor physical therapy: Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.
Patient Global Impression of Improvement-Incontinence	2.25 score on a scale Standard Deviation 0.05	3.00 score on a scale Standard Deviation 0.05	3.75 score on a scale Standard Deviation 0.05

SECONDARY outcome

Timeframe: 7 days

Patient treatment preference will be assessed after completion of initial assigned therapy utilizing the product performance questionnaire (PPQ). The PPQ is a 13-item product questionnaire that consists of product questions that are specific to incontinence products and includes questions about overall impression of product, ability to hold urine, ability to prevent odor, fit, discreteness, comfort when wet and dry, and ability to keep skin dry. Patients are allowed to answer each question with either "unacceptable (1)," "acceptable (2) ," or "good (3) " to each question. Therefor minimum on questionnaire is a 0 and maximum is 39 with higher score showing improved patient treatment preference/performance of product.

Outcome measures

Outcome measures
Measure	Disposable Urethral Support Device n=4 Participants disposable urethral support device Disposable urethral support: The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)	Reusable Underwear n=4 Participants Reusable Underwear Reusable Underwear: Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection	Pelvic Floor Muscle Therapy (PFMT) n=4 Participants Pelvic floor muscle therapy Pelvic floor physical therapy: Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.
Patient Treatment Preference	23 units on a scale Interval 19.0 to 34.0	37 units on a scale Interval 31.0 to 38.0	38 units on a scale Interval 37.0 to 39.0

SECONDARY outcome

Timeframe: 7 days

The KHQ is a 21-item scale with 9 domains: general health perceptions, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, Sleep/Energy, and severity measures and an 11-item symptom severity score. (Hebbar et al., 2015) Each question has four options "not at all", "a little", "moderately" and "a lot". (numerically 1-4) The general health perception domain has five choices ("very good", "good", "fair", "bad" and "very bad") (numerically 1-5). The scores are then converted to "out of 100" with accepted formulas. For example for Q1 the overall score = ((actual score-1)/4)\*100 In the KHQ, a minimum possible score of zero is assigned to the best health and a maximum possible score of 100 is assigned to the worst health. The 0-100 scale is used for each item and each subscale separately. You can then report a total average score across all domains which is reported here

Outcome measures

Outcome measures
Measure	Disposable Urethral Support Device n=4 Participants disposable urethral support device Disposable urethral support: The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)	Reusable Underwear n=4 Participants Reusable Underwear Reusable Underwear: Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection	Pelvic Floor Muscle Therapy (PFMT) n=4 Participants Pelvic floor muscle therapy Pelvic floor physical therapy: Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.
King's Health Questionnaire	66.7 units on a scale Standard Deviation 23.6	33.3 units on a scale Standard Deviation 23.6	25 units on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: 7 days

Subjects will be asked to document their adherence to therapy on a daily basis and outcome will be reported as the percentage of participants with 100% adherence (responded yes to adherence to therapy all 7 days of therapy on their daily log)

Outcome measures

Outcome measures
Measure	Disposable Urethral Support Device n=4 Participants disposable urethral support device Disposable urethral support: The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)	Reusable Underwear n=4 Participants Reusable Underwear Reusable Underwear: Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection	Pelvic Floor Muscle Therapy (PFMT) n=4 Participants Pelvic floor muscle therapy Pelvic floor physical therapy: Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.
Adherence Logs	3 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 7 days

At the end of the study, all participants will be asked to indicate how easy it would be to continue practicing their assignment intervention (extremely, very, moderately, somewhat, and not at all easy) and complete the Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire which asks "would you be willing to continue treatment with this product or therapy?" The reported outcome is the number of participants per group that answered "Yes" to this question.

Outcome measures

Outcome measures
Measure	Disposable Urethral Support Device n=4 Participants disposable urethral support device Disposable urethral support: The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)	Reusable Underwear n=4 Participants Reusable Underwear Reusable Underwear: Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection	Pelvic Floor Muscle Therapy (PFMT) n=4 Participants Pelvic floor muscle therapy Pelvic floor physical therapy: Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.
Benefits, Satisfaction, and Willingness to Continue	0 Participants	4 Participants	4 Participants

Adverse Events

Disposable Urethral Support Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reusable Underwear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pelvic Floor Muscle Therapy (PFMT)

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

Megan Bradley, MD

University of Pittsburgh

Phone: 2487701681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place