Terminé

IIMPACTIncontinence & Intimate Partners: Assessing the Contribution of Treatment

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Ce qui est testé

Solifenacin

Médicament
Qui peut participer

Maladies génito-urinaires+9

+ Maladies urogénitales féminines et complications de la grossesse

+ Signes et symptômes

À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Soins de support

Phase 4
Interventionnel
Date de début : mars 2012
Voir le détail du protocole

Résumé

Sponsor principalLoyola University
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 9 mars 2012

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielIncontinence & Intimate Partners: Assessing the Contribution of Treatment
Sponsor principalLoyola University
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

138 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Soins de support

Cette étude teste des approches visant à améliorer le confort, le bien-être ou la qualité de vie des personnes atteintes d'une maladie, notamment en aidant à mieux gérer les symptômes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies génito-urinairesMaladies urogénitales féminines et complications de la grossesseSignes et symptômesConditions pathologiques, signes et symptômesIncontinence urinaireTroubles de la mictionMaladies urologiquesManifestations urologiquesMaladies urogénitales masculinesMaladies urogénitales fémininesIncontinence urinaire impérieuseSymptômes des voies urinaires inférieures

Critères

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

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Loyola University Medical Center

Maywood, United StatesOuvrir Loyola University Medical Center dans Google Maps
Terminé1 Centres d'Étude