IIMPACT: Incontinence & Intimate Partners: Assessing the Contribution of Treatment

• Sponsor: Loyola University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01559389
• Collaborator: Astellas Pharma US, Inc. (Industry)
• Enrollment: 138
• Location: 1
• Arms: 2
• Actual Duration (Months): 63.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Urge urinary incontinence (UUI) is a socially debilitating disease due to its inherently unpredictable nature and sometimes large volumes of urine loss. Women with UUI may experience anxiety over public episodes of incontinence and concerns about odor and, as a result, isolate themselves socially. This isolation affects both partners in the relationship and may be a source of discord. The impact of UUI also moves into personal relationships where fears or actual episodes of incontinence during physical intimacy, including but limited to intercourse, may result in limited interactions and changes in the relationship satisfaction for both partners. Few studies have examined the role of urinary incontinence, particularly UUI, in the dynamics of an intimate partner relationship and none have evaluated the impact of successful UUI treatment.

The long-term goal of our research is to understand the social and emotional impact of pelvic floor disorders, particularly UUI, on the well-being of an intimate relationship. Ultimately, we aim to evaluate the role that successful treatment plays in the alleviation of discord in intimate partner relationships that are affected by UUI and other pelvic floor disorders.

Our objective for this proposal is to characterize, using validated, quantifiable methods the quality of the relationship in couples affected by UUI and to identify the role that treatment plays in improving this relationship. Our central hypothesis is that UUI has a negative impact upon the emotional and physical well-being of a relationship and that effective treatment will result in improvement in areas of the relationship that have been detrimentally affected by UUI. Our rationale for this study is that an understanding of UUI in the context of a couple, particularly from the perspective of the male partner, will improve our ability to holistically treat UUI, thus improving patient outcomes and satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Urge Urinary Incontinence	Drug: Solifenacin	Phase 4

Detailed Description

Chronic illness places emotional, physical, and financial burdens upon both the patient and her partner and can be a significant source of stress in a relationship. The symptoms of UUI inherently pose greater social challenges than those faced by women other forms of pelvic floor disorders. For example, women with UUI may avoid social situations due to fear of having an accident or may be reluctant to participate in activities during which it may be difficult to find a bathroom. The resulting social isolation impacts both members of the dyad and may serve as a source of relationship discord. Changes in sexual function and perceived intimacy, including non-intercourse intimacy, as well as communication may be new sources of stress in a previously healthy relationship or may serve to amplify pre-existing relationship problems.

Sexual function is another area in which UUI may cause a negative impact. Studies of coital incontinence among incontinent clinic populations report prevalence ranging from 10%-56% with a median of 22%. The prevalence of coital incontinence may be related to the type of incontinence as well as the severity of symptoms. Stress incontinence has been associated with leakage of urine during intercourse, while detrusor instability and urge incontinence have been correlated with leakage during orgasm. A cross-sectional study of women with UUI and urinary incontinence found that among women reporting low sexual desire, stress incontinence was common (47%), while 46% of women reporting orgasmic phase dysfunction reported symptoms of urge incontinence. Qualitative data corroborates the negative impact of UUI on dyadic and sexual relations.

Another mechanism by which UUI may affect satisfaction with dyadic relations is through depressive symptomatology. Urinary incontinence is associated with a decrease in overall health-related quality of life and is positively correlated with depression, anxiety, and stress. Studies of other chronic illnesses demonstrate a correlation between the patient's level of depression and that of their spouse; level of depression shows an inverse relationship with degree of satisfaction with the relationship.

One of the two studies in the published literature that use quantitative methods to evaluate the impact of urodynamic stress incontinence and detrusor overactivity on the marital relationship concluded that both sexual function and marital relationships are negatively affected by incontinence. This study, like others, is based upon the perspective of the female partner. A recent study of Swedish women with urinary incontinence and urgency is the only study which includes the perspective of the male partner to examine the impact of UUI on the relationship. It concludes that, "Female urinary incontinence, urgency and frequency significantly impair the quality of life in both younger and older women, and also have negative effects on the partner relationship and the partner's life".

The perspective of intimate partners of women with UUI and other forms of PFD is largely missing from the literature. Any analysis of the role of UUI in intimate partner relationships is incomplete without this perspective.

Study Design

• Study Type: Interventional
• Actual Enrollment: 138 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Women presenting with UUI symptoms will receive up to 16 weeks of solifenacin.Women presenting with UUI symptoms will receive up to 16 weeks of solifenacin.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Incontinence & Intimate Partners: Assessing the Contribution of Treatment
• Actual Study Start Date: Mar 9, 2012
• Actual Primary Completion Date: Jun 29, 2017
• Actual Study Completion Date: Jun 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Female Partners This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms	Drug: Solifenacin; Women presenting with UUI symptoms receive 5 to 10 milligrams (mg) of daily solifenacin for up to 16 weeks; Other Names: Vesicare
No Intervention: Male Partners This arm comprises healthy male partners

Outcome Measures

Primary Outcome Measures

1. Baseline Sexual Satisfaction Between Matched Female and Male Partners [0 Weeks]

   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.

Secondary Outcome Measures

1. Change in Overall Sexual Satisfaction Among Females [Baseline and 12-16 weeks]

   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.

2. Change in Overall Sexual Satisfaction Among Healthy Male Partners [Baseline and 12-16 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Healthy male partners may volunteer to participate in this study along with their affected female partners. There are no inclusion or exclusion criteria for male partners.

For affected female participants, the following inclusion criteria apply:

• Age ≥ 18 years

• In a relationship with a male partner for at least 3 months

• Not pregnant or planning to become pregnant

• Have a diagnosis of UUI or Mixed Urinary Incontinence (MUI) that is urge predominant based on a 3 day voiding diary

• Are interested in medical management of their symptoms

• Are candidates for solifenacin

• Are able to provide informed consent

• Are able to complete written questionnaires.

For affected female partners, the following exclusion criteria apply:

• Post Voided Residual (PVR) > 200 ml at the initial visit

• History of a significant outflow obstruction

• History of persistent/recurrent Urinary Tract Infection (UTI)

• History of bladder stones

• History of a diagnosis of chronic interstitial cystitis

• History of pelvic irradiation

• Current pelvic malignancy

• Narrow angle glaucoma

• Urinary or gastric retention

• Current use of a tricyclic antidepressant

• A neurologic diagnosis that could affect bladder function

• History of chronic pelvic pain

• Active psychotic disorder

• Male partner does not speak English

• Declines permission for the study team to recruit their male partner for the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Medical Center	Maywood	Illinois	United States	60153

Sponsors and Collaborators

• Loyola University
• Astellas Pharma US, Inc.

Investigators

• Principal Investigator: Elizabeth Meuller, MD, Loyola University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2018

More Information

Publications

• Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13.
• Bovbjerg VE, Trowbridge ER, Barber MD, Martirosian TE, Steers WD, Hullfish KL. Patient-centered treatment goals for pelvic floor disorders: association with quality-of-life and patient satisfaction. Am J Obstet Gynecol. 2009 May;200(5):568.e1-6. doi: 10.1016/j.ajog.2008.11.020. Epub 2009 Feb 23.
• Coyne KS, Matza LS, Brewster-Jordan J. "We have to stop again?!": The impact of overactive bladder on family members. Neurourol Urodyn. 2009;28(8):969-75. doi: 10.1002/nau.20705.
• Coyne KS, Wein AJ, Tubaro A, Sexton CC, Thompson CL, Kopp ZS, Aiyer LP. The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:4-11. doi: 10.1111/j.1464-410X.2009.08371.x.
• Daneker B, Kimmel PL, Ranich T, Peterson RA. Depression and marital dissatisfaction in patients with end-stage renal disease and in their spouses. Am J Kidney Dis. 2001 Oct;38(4):839-46.
• Herzog AR, Diokno AC, Brown MB, Normolle DP, Brock BM. Two-year incidence, remission, and change patterns of urinary incontinence in noninstitutionalized older adults. J Gerontol. 1990 Mar;45(2):M67-74.
• Hilton P. Urinary incontinence during sexual intercourse: a common, but rarely volunteered, symptom. Br J Obstet Gynaecol. 1988 Apr;95(4):377-81.
• Jacobson NS, Follette WC, McDonald DW. Reactivity to positive and negative behavior in distressed and nondistressed married couples. J Consult Clin Psychol. 1982 Oct;50(5):706-14.
• Jacobson NS. A component analysis of behavioral marital therapy: the relative effectiveness of behavior exchange and communication/problem-solving training. J Consult Clin Psychol. 1984 Apr;52(2):295-305.
• Johnson SM, Greenberg LS. Differential effects of experiential and problem-solving interventions in resolving marital conflict. J Consult Clin Psychol. 1985 Apr;53(2):175-84.
• Litman HJ, Steers WD, Wei JT, Kupelian V, Link CL, McKinlay JB; Boston Area Community Health Survey Investigators. Relationship of lifestyle and clinical factors to lower urinary tract symptoms: results from Boston Area Community Health survey. Urology. 2007 Nov;70(5):916-21. Epub 2007 Oct 24.
• Nathan EP, Joanning HH. Enhancing marital sexuality: an evaluation of a program for the sexual enrichment of normal couples. J Sex Marital Ther. 1985 Fall;11(3):157-64.
• Nilsson M, Lalos A, Lalos O. The impact of female urinary incontinence and urgency on quality of life and partner relationship. Neurourol Urodyn. 2009;28(8):976-81. doi: 10.1002/nau.20709. Erratum in: Neurourol Urodyn. 2012 Apr;31(4):607. Margareta, Nilsson [corrected to Nilsson, Margareta]; Ann, Lalos [corrected to Lalos, Ann]; Othon, Lalos [corrected to Lalos, Othon].
• Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Epub 2003 Jul 25. Erratum in: Int Urogynecol J Pelvic Floor Dysfunct. 2004 May-Jun;15(3):219.
• Rust J, Golombok S. The Golombok-Rust Inventory of Sexual Satisfaction (GRISS). Br J Clin Psychol. 1985 Feb;24 ( Pt 1):63-4.
• Salonia A, Zanni G, Nappi RE, Briganti A, Dehò F, Fabbri F, Colombo R, Guazzoni G, Di Girolamo V, Rigatti P, Montorsi F. Sexual dysfunction is common in women with lower urinary tract symptoms and urinary incontinence: results of a cross-sectional study. Eur Urol. 2004 May;45(5):642-8; discussion 648.
• Shaw C. A systematic review of the literature on the prevalence of sexual impairment in women with urinary incontinence and the prevalence of urinary leakage during sexual activity. Eur Urol. 2002 Nov;42(5):432-40. Review.
• Spanier GB. The measurement of marital quality. J Sex Marital Ther. 1979 Fall;5(3):288-300.
• Yip SK, Chan A, Pang S, Leung P, Tang C, Shek D, Chung T. The impact of urodynamic stress incontinence and detrusor overactivity on marital relationship and sexual function. Am J Obstet Gynecol. 2003 May;188(5):1244-8.

• Responsible Party: Elizabeth Mueller, Associate Professor, Loyola University
• ClinicalTrials.gov Identifier: NCT01559389
• Other Study ID Numbers: 203952
• First Posted: Mar 21, 2012
• Last Update Posted: Dec 2, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Elizabeth Mueller, Associate Professor, Loyola University: Urge Urinary Incontinence; Vesicare; Urinary Incontinence; Sexual function; solifenacin
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Solifenacin Succinate

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Females With UUI	Male Partners
Arm/Group Description	This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms	This arm comprises the healthy male partners of the female participants
Period Title: Overall Study
STARTED	69	69
COMPLETED	49	49
NOT COMPLETED	20	20

Baseline Characteristics

Arm/Group Title	Females With UUI	Male Partners	Total
Arm/Group Description	This arm comprises females who receive up to 16 weeks of solifenacin treatment for their UUI symptoms	This arm comprises the healthy male partners of the female participants	Total of all reporting groups
Overall Participants	49	49	98
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	49 100%	49 100%	98 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	49 100%	0 0%	49 50%
Male	0 0%	49 100%	49 50%
Race/Ethnicity, Customized (Count of Participants)
White	37 75.5%	36 73.5%	73 74.5%
Black	8 16.3%	8 16.3%	16 16.3%
Asian	0 0%	1 2%	1 1%
Hispanic	4 8.2%	3 6.1%	7 7.1%
Other	0 0%	1 2%	1 1%
Region of Enrollment (participants) [Number]
United States	49 100%	49 100%	98 100%
Marital Status (Count of Participants)
Married	42 85.7%	42 85.7%	84 85.7%
Divorced	3 6.1%	1 2%	4 4.1%
Single	4 8.2%	6 12.2%	10 10.2%
Education (Count of Participants)
High school or less	19 38.8%	0 0%	19 19.4%
At least some college	29 59.2%	0 0%	29 29.6%
Not reported	1 2%	0 0%	1 1%
Years with Partner (Count of Participants)
Fewer than 30 years	24 49%	23 46.9%	47 48%
30 or more years	25 51%	26 53.1%	51 52%
Body Mass Index (Count of Participants)
Less than 30 kg/m^2	19 38.8%	19 38.8%
30 kg/m^2 or more	30 61.2%	30 61.2%
Menstrual Cycle (Count of Participants)
Pre-menopausal	9 18.4%	0 0%	9 9.2%
Post-menopausal	38 77.6%	0 0%	38 38.8%
Not certain	2 4.1%	0 0%	2 2%
Vaginal Parity (Count of Participants)
0-1 births	8 16.3%	0 0%	8 8.2%
2 births	20 40.8%	0 0%	20 20.4%
3 births	10 20.4%	0 0%	10 10.2%
4-6 births	11 22.4%	0 0%	11 11.2%
Prior Surgery (Count of Participants)
Yes	27 55.1%	27 55.1%
No	22 44.9%	22 44.9%
Prior Treatments for Overactive Bladder Syndrome (Count of Participants)
Yes	19 38.8%	19 38.8%
No	30 61.2%	30 61.2%
Prior Treatment for Pelvic Floor Disorders (Count of Participants)
Yes	20 40.8%	20 40.8%
No	29 59.2%	29 59.2%
General Health (Count of Participants)
Excellent	4 8.2%	8 16.3%	12 12.2%
Very Good	10 20.4%	16 32.7%	26 26.5%
Good	25 51%	16 32.7%	41 41.8%
Fair	8 16.3%	8 16.3%	16 16.3%
Poor	2 4.1%	1 2%	3 3.1%
Medical History (Count of Participants)
Hypertension	0 0%	16 32.7%	16 16.3%
Erectile dysfunction	0 0%	13 26.5%	13 13.3%
Arthritis	0 0%	13 26.5%	13 13.3%
Diabetes	0 0%	9 18.4%	9 9.2%
Cancer	0 0%	9 18.4%	9 9.2%
Heart disease	0 0%	6 12.2%	6 6.1%
Depression	0 0%	6 12.2%	6 6.1%
Currently Sexually Active (Count of Participants)
Yes	36 73.5%	36 73.5%
No	13 26.5%	13 26.5%

Outcome Measures

1. Primary Outcome

Title	Baseline Sexual Satisfaction Between Matched Female and Male Partners
Description	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.
Time Frame	0 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Females With UUI	Male Partners
Arm/Group Description	This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms	This arm comprises the healthy male partners of the female participants
Measure Participants	49	49
Mean (Standard Deviation) [score on a scale]	4.2 (2.3)	4.8 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Females With UUI, Male Partners
	Comments	The null hypothesis is that there is no difference in the overall GRISS score between females with UUI and their male partners
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.16
	Comments	P-values less than 0.05 were considered statistically significant.
	Method	t-test, 2 sided
	Comments	The method was a paired t-test
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -1.23 to 0.21
	Parameter Dispersion	Type: Standard Deviation; Value: 2.50
	Estimation Comments

2. Secondary Outcome

Title	Change in Overall Sexual Satisfaction Among Females
Description	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.
Time Frame	Baseline and 12-16 weeks

Outcome Measure Data

Analysis Population Description

The analysis population comprises 49 female participants who received up to 16 weeks of solifenacin for the treatment of UUI symptoms

Arm/Group Title	Responder	Non-Responder
Arm/Group Description	This arm comprises female participants who respond to solifenacin treatment for their UUI symptoms. Response to treatment comprises those who rate their Global Impression of Improvement (GII) as "a little better", "much better", or "very much better"	This arm comprises female participants who do not respond to solifenacin treatment for their UUI symptoms. Non-response to treatment is defined as those who rate their Global Impression of Improvement (GII) as "no change", "a little worse", "much worse", and "very much worse".
Measure Participants	14	35
Median (Inter-Quartile Range) [score on a scale]	-0.5	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Females With UUI, Male Partners
	Comments	The null hypothesis is that there is no difference in the overall GRISS change score between those who respond and do not respond to treatment with solifenacin.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.003
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Exact test
Method of Estimation	Estimation Parameter	z-score
	Estimated Value	2.97
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between responders and non-responders of solifenacin treatment

3. Secondary Outcome

Title	Change in Overall Sexual Satisfaction Among Healthy Male Partners
Description	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.
Time Frame	Baseline and 12-16 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Male Partners of Female Responders	Male Partners of Female Non-Responders
Arm/Group Description	This arm comprises the male partners of female participants who respond to solifenacin treatment for their UUI symptoms	This arm comprises the male partners of female participants who do not respond to solifenacin treatment for their UUI symptoms
Measure Participants	14	35
Median (Inter-Quartile Range) [score on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Females With UUI, Male Partners
	Comments	The null hypothesis is that there is no difference in the overall GRISS change score between male partners of female participants who respond to solifenacin and male partners of female participants who do not respond to solifenacin
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.37
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	z-score
	Estimated Value	0.89
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between the two groups

Adverse Events

Time Frame	Adverse event data were collected for each female participant from March 2012 to June 2017 (i.e., 64 months)
Adverse Event Reporting Description	Male partners were not prescribed solifenacin and, consequently, were not at risk for adverse events. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed for Male Partners.
Arm/Group Title	Females With UUI		Male Partners
Arm/Group Description	This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms		This arm comprises the healthy male partners of the female participants. They were not prescribed solifenacin and, consequently, were not at risk for adverse events
All Cause Mortality
	Females With UUI		Male Partners
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/0 (NaN)
Serious Adverse Events
	Females With UUI		Male Partners
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Females With UUI		Male Partners
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/0 (NaN)

Limitations/Caveats

There are no limitations or caveats to report

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.