Trial Outcomes & Findings for Incontinence & Intimate Partners: Assessing the Contribution of Treatment (NCT NCT01559389)
NCT ID: NCT01559389
Last Updated: 2019-12-02
Results Overview
Prior to beginning treatment with solifenacin, females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS). Their male partners also complete the GRISS at the baseline visit. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
138 participants
Primary outcome timeframe
0 Weeks
Results posted on
2019-12-02
Participant Flow
Patients were recruited from March 2012 through July 2016 (52 months) from the Division of Female Pelvic Medicine \& Reconstructive Surgery at Loyola University Medical Center.
Participant milestones
| Measure |
Females With UUI
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
|
Male Partners
This arm comprises the healthy male partners of the female participants
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
69
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
Reasons for withdrawal
| Measure |
Females With UUI
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
|
Male Partners
This arm comprises the healthy male partners of the female participants
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
20
|
20
|
Baseline Characteristics
Information on education is only collected for female participants
Baseline characteristics by cohort
| Measure |
Females With UUI
n=49 Participants
This arm comprises females who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
|
Male Partners
n=49 Participants
This arm comprises the healthy male partners of the female participants
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=98 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=49 Participants
|
49 Participants
n=49 Participants
|
98 Participants
n=98 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=49 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=98 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=49 Participants
|
0 Participants
n=49 Participants
|
49 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=49 Participants
|
49 Participants
n=49 Participants
|
49 Participants
n=98 Participants
|
|
Race/Ethnicity, Customized
White
|
37 Participants
n=49 Participants
|
36 Participants
n=49 Participants
|
73 Participants
n=98 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=49 Participants
|
8 Participants
n=49 Participants
|
16 Participants
n=98 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=49 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=98 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=49 Participants
|
3 Participants
n=49 Participants
|
7 Participants
n=98 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=49 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=98 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
49 participants
n=49 Participants
|
98 participants
n=98 Participants
|
|
Marital Status
Married
|
42 Participants
n=49 Participants
|
42 Participants
n=49 Participants
|
84 Participants
n=98 Participants
|
|
Marital Status
Divorced
|
3 Participants
n=49 Participants
|
1 Participants
n=49 Participants
|
4 Participants
n=98 Participants
|
|
Marital Status
Single
|
4 Participants
n=49 Participants
|
6 Participants
n=49 Participants
|
10 Participants
n=98 Participants
|
|
Education
High school or less
|
19 Participants
n=49 Participants • Information on education is only collected for female participants
|
0 Participants
Information on education is only collected for female participants
|
19 Participants
n=49 Participants • Information on education is only collected for female participants
|
|
Education
At least some college
|
29 Participants
n=49 Participants • Information on education is only collected for female participants
|
0 Participants
Information on education is only collected for female participants
|
29 Participants
n=49 Participants • Information on education is only collected for female participants
|
|
Education
Not reported
|
1 Participants
n=49 Participants • Information on education is only collected for female participants
|
0 Participants
Information on education is only collected for female participants
|
1 Participants
n=49 Participants • Information on education is only collected for female participants
|
|
Years with Partner
Fewer than 30 years
|
24 Participants
n=49 Participants
|
23 Participants
n=49 Participants
|
47 Participants
n=98 Participants
|
|
Years with Partner
30 or more years
|
25 Participants
n=49 Participants
|
26 Participants
n=49 Participants
|
51 Participants
n=98 Participants
|
|
Body Mass Index
Less than 30 kg/m^2
|
19 Participants
n=49 Participants • Information on body mass index is only collected for female participants
|
—
|
19 Participants
n=49 Participants • Information on body mass index is only collected for female participants
|
|
Body Mass Index
30 kg/m^2 or more
|
30 Participants
n=49 Participants • Information on body mass index is only collected for female participants
|
—
|
30 Participants
n=49 Participants • Information on body mass index is only collected for female participants
|
|
Menstrual Cycle
Pre-menopausal
|
9 Participants
n=49 Participants • Information on menopause is only collected for female participants
|
0 Participants
Information on menopause is only collected for female participants
|
9 Participants
n=49 Participants • Information on menopause is only collected for female participants
|
|
Menstrual Cycle
Post-menopausal
|
38 Participants
n=49 Participants • Information on menopause is only collected for female participants
|
0 Participants
Information on menopause is only collected for female participants
|
38 Participants
n=49 Participants • Information on menopause is only collected for female participants
|
|
Menstrual Cycle
Not certain
|
2 Participants
n=49 Participants • Information on menopause is only collected for female participants
|
0 Participants
Information on menopause is only collected for female participants
|
2 Participants
n=49 Participants • Information on menopause is only collected for female participants
|
|
Vaginal Parity
0-1 births
|
8 Participants
n=49 Participants • Information on parity is only collected for female participants
|
0 Participants
Information on parity is only collected for female participants
|
8 Participants
n=49 Participants • Information on parity is only collected for female participants
|
|
Vaginal Parity
2 births
|
20 Participants
n=49 Participants • Information on parity is only collected for female participants
|
0 Participants
Information on parity is only collected for female participants
|
20 Participants
n=49 Participants • Information on parity is only collected for female participants
|
|
Vaginal Parity
3 births
|
10 Participants
n=49 Participants • Information on parity is only collected for female participants
|
0 Participants
Information on parity is only collected for female participants
|
10 Participants
n=49 Participants • Information on parity is only collected for female participants
|
|
Vaginal Parity
4-6 births
|
11 Participants
n=49 Participants • Information on parity is only collected for female participants
|
0 Participants
Information on parity is only collected for female participants
|
11 Participants
n=49 Participants • Information on parity is only collected for female participants
|
|
Prior Surgery
Yes
|
27 Participants
n=49 Participants • Information on prior surgery is only collected for female participants
|
—
|
27 Participants
n=49 Participants • Information on prior surgery is only collected for female participants
|
|
Prior Surgery
No
|
22 Participants
n=49 Participants • Information on prior surgery is only collected for female participants
|
—
|
22 Participants
n=49 Participants • Information on prior surgery is only collected for female participants
|
|
Prior Treatments for Overactive Bladder Syndrome
Yes
|
19 Participants
n=49 Participants • Information on prior treatments for Overactive Bladder Syndrome is only collected for female participants
|
—
|
19 Participants
n=49 Participants • Information on prior treatments for Overactive Bladder Syndrome is only collected for female participants
|
|
Prior Treatments for Overactive Bladder Syndrome
No
|
30 Participants
n=49 Participants • Information on prior treatments for Overactive Bladder Syndrome is only collected for female participants
|
—
|
30 Participants
n=49 Participants • Information on prior treatments for Overactive Bladder Syndrome is only collected for female participants
|
|
Prior Treatment for Pelvic Floor Disorders
Yes
|
20 Participants
n=49 Participants • Measure Analysis Population Description: Information on prior treatments for pelvic floor disorders is only collected for female participants
|
—
|
20 Participants
n=49 Participants • Measure Analysis Population Description: Information on prior treatments for pelvic floor disorders is only collected for female participants
|
|
Prior Treatment for Pelvic Floor Disorders
No
|
29 Participants
n=49 Participants • Measure Analysis Population Description: Information on prior treatments for pelvic floor disorders is only collected for female participants
|
—
|
29 Participants
n=49 Participants • Measure Analysis Population Description: Information on prior treatments for pelvic floor disorders is only collected for female participants
|
|
General Health
Excellent
|
4 Participants
n=49 Participants
|
8 Participants
n=49 Participants
|
12 Participants
n=98 Participants
|
|
General Health
Very Good
|
10 Participants
n=49 Participants
|
16 Participants
n=49 Participants
|
26 Participants
n=98 Participants
|
|
General Health
Good
|
25 Participants
n=49 Participants
|
16 Participants
n=49 Participants
|
41 Participants
n=98 Participants
|
|
General Health
Fair
|
8 Participants
n=49 Participants
|
8 Participants
n=49 Participants
|
16 Participants
n=98 Participants
|
|
General Health
Poor
|
2 Participants
n=49 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=98 Participants
|
|
Medical History
Hypertension
|
0 Participants
Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
16 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
16 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
|
Medical History
Erectile dysfunction
|
0 Participants
Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
13 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
13 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
|
Medical History
Arthritis
|
0 Participants
Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
13 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
13 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
|
Medical History
Diabetes
|
0 Participants
Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
9 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
9 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
|
Medical History
Cancer
|
0 Participants
Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
9 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
9 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
|
Medical History
Heart disease
|
0 Participants
Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
6 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
6 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
|
Medical History
Depression
|
0 Participants
Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
6 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
6 Participants
n=49 Participants • Information on hypertension, erectile dysfunction, arthritis, diabetes, cancer, heart disease, and depression is only collected for male participants
|
|
Currently Sexually Active
Yes
|
—
|
36 Participants
n=49 Participants • Information on current sexual activity is only collected for male participants
|
36 Participants
n=49 Participants • Information on current sexual activity is only collected for male participants
|
|
Currently Sexually Active
No
|
—
|
13 Participants
n=49 Participants • Information on current sexual activity is only collected for male participants
|
13 Participants
n=49 Participants • Information on current sexual activity is only collected for male participants
|
PRIMARY outcome
Timeframe: 0 WeeksPrior to beginning treatment with solifenacin, females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS). Their male partners also complete the GRISS at the baseline visit. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction.
Outcome measures
| Measure |
Females With UUI
n=49 Participants
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
|
Male Partners
n=49 Participants
This arm comprises the healthy male partners of the female participants
|
|---|---|---|
|
Baseline Sexual Satisfaction Between Matched Female and Male Partners
|
4.2 score on a scale
Standard Deviation 2.3
|
4.8 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline and 12-16 weeksPopulation: The analysis population comprises 49 female participants who received up to 16 weeks of solifenacin for the treatment of UUI symptoms
Females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) at baseline (0 weeks) and after 12-16 weeks of treatment with solifenacin. For this outcome, the baseline score is subtracted from the follow-up score and this change score is compared between those who respond and do not respond to treatment with solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction.
Outcome measures
| Measure |
Females With UUI
n=14 Participants
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
|
Male Partners
n=35 Participants
This arm comprises the healthy male partners of the female participants
|
|---|---|---|
|
Change in Overall Sexual Satisfaction Among Females
|
-0.5 score on a scale
Interval -1.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and 12-16 weeksPopulation: The analysis population comprises the 49 male partners of the female participants who received up to 16 weeks of solifenacin for the treatment of UUI symptoms
Healthy male partners of female participants complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) survey. For this outcome, their baseline score is subtracted from their follow-up score which is collected after their female partner completes approximately 12-16 weeks of solifenacin treatment for UUI symptoms. This change score is compared between male partners of female participants who respond to solifenacin versus male partners of female participants who do not respond to solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction.
Outcome measures
| Measure |
Females With UUI
n=14 Participants
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
|
Male Partners
n=35 Participants
This arm comprises the healthy male partners of the female participants
|
|---|---|---|
|
Change in Overall Sexual Satisfaction Among Healthy Male Partners
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -1.0 to 0.0
|
Adverse Events
Females With UUI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Male Partners
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place