Female Artificial Urinary Sphincter Implantation
Conditions
Keywords
Artificial urinary sphincter, Urinary Incontinence, Sexual function, Sexual quality of life
Brief summary
Urinary incontinence (UI) is a common and disabling condition that affects millions of people worldwide and significantly impacts the quality of life of those affected. It is well established that urinary incontinence negatively affects sexual life. Although there is no definitive consensus yet, many authors report that sexual function, after surgical intervention to restore continence, is likely to improve or, at the very least, remain unchanged.
Detailed description
The primary objective of the study is to evaluate sexual function in women 6 months after implantation of an artificial urinary sphincter. Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively. The patients concerned are women who have undergone implantation of an artificial urinary sphincter. Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively.
Interventions
OTHERquestionnaires
The PISQ-12 questionnaire, which explores female sexual function; the ICIQ-FLUTSsex questionnaire, which focuses on the impact of urinary leakage on sexuality; the USP questionnaire, which assesses the frequency and characteristics of urinary incontinence; and the Qualiveen-SF questionnaire, which measures the impact of these urinary disorders on daily life. A bladder diary was completed preoperatively as well as during follow-up visits at 6 and 12 months.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18 to 80 years * Patients with from urinary incontinence with an appropriate surgical indication for artificial urinary sphincter implantation * Patients who accept the surgical indication and have signed the informed consent for the procedure * No objection from the patients to participate in the study after reading the information sheet
Exclusion criteria
* \- Pregnant or breastfeeding patients * Life expectancy of less than 2 years * Patients who have undergone colpocleisis surgery * Patients with neurological conditions causing loss of sensation * Patients reporting no interest in sexual activity * Patients suffering from chronic pelvic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess sexual function | 6 months | sexual quality of life assessed at 6 months post operatively by the PISQ-12 questionnaire (scale from 0 to 48). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess sexual function | 12 months | sexual quality of life assessed at 12 months post operatively by the PISQ-12 questionnaire. |
| Assess sexual quality of life | 6 and 12 months | sexual quality of life assessed at 6 and 12 months post operatively by the ICIQ-FLUTSsex questionnaire. |
| Assess urinary incontinence (clinical efficacy) | 6 and 12 months | sexual quality of life assessed at 6 and 12 months post operatively by the USP questionnaire. |
| Assess quality of life | 6 and 12 months | Quality of life assessed at 6 and 12 months post operatively by the Qualiveen SF questionnaire. |
| Assess complications | 6 and 12 months | Surgical complications assessed at 6 and 12 months post according to the Calvien Dindo. |
Countries
France
Contacts
CONTACTVéronique PHE, PU-PH
CONTACTNour KHALIL, PhD
PRINCIPAL_INVESTIGATORVéronique PHE, PU-PH
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed