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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01903-46 | Other Identifier | IDRCB |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess sexual function | sexual quality of life assessed at 6 months post operatively by the PISQ-12 questionnaire (scale from 0 to 48). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess sexual function | sexual quality of life assessed at 12 months post operatively by the PISQ-12 questionnaire. | 12 months |
| Assess sexual quality of life | sexual quality of life assessed at 6 and 12 months post operatively by the ICIQ-FLUTSsex questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
Female
Patients who have benefited from the surgical implantation of an artificial urinary sphincter
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Véronique PHE, PU-PH | Contact | 01.56.01.61.95 | +33 | veronique.phe@aphp.fr |
| Nour KHALIL, PhD | Contact | 01.56.01.61.95 | +33 | nour.khalil@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Véronique PHE, PU-PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Tenon, service d'urologie | Paris | 75020 | France |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 6 and 12 months |
| Assess urinary incontinence (clinical efficacy) | sexual quality of life assessed at 6 and 12 months post operatively by the USP questionnaire. | 6 and 12 months |
| Assess urinary incontinence (clinical efficacy) | A voiding diary at 6 and 12 months (reporting the number of leaks per day),with a comparison to the preoperative value. Where applicable, the number of pads used per day. | 6 and 12 months |
| Assess quality of life | Quality of life assessed at 6 and 12 months post operatively by the Qualiveen SF questionnaire. | 6 and 12 months |
| Assess complications | Surgical complications assessed at 6 and 12 months post according to the Calvien Dindo. | 6 and 12 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |