Female Artificial Urinary Sphincter ImplantationSPHINCTERNCT07399509
Evaluation of Sexual Function After Artificial Urinary Sphincter Implantation
An observational study of Female Artificial Urinary Sphincter Implantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Female Artificial Urinary Sphincter Implantation
- What is being tested?
- questionnaires
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Feb 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have benefited from the surgical implantation of an artificial urinary sphincter
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Tenon, service d'urologie
Paris, 75020
Véronique PHE, PU-PH, 01.56.01.61.95 ext. +33, veronique.phe@aphp.fr
Nour KHALIL, PhD, 01.56.01.61.95 ext. +33, nour.khalil@aphp.fr
About this study
Official title: Prospective Observational Study Evaluating the Sexual Function After Insertion of an Artificial Urinary Sphincter in Women
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.
Read the 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.
- Being tested
- questionnaires
- Keywords
- Artificial urinary sphincter, Urinary Incontinence, Sexual function, Sexual quality of life
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess sexual function
sexual quality of life assessed at 6 months post operatively by the PISQ-12 questionnaire (scale from 0 to 48).
Measured: 6 months
Secondary outcomes (6)
Assess sexual function
sexual quality of life assessed at 12 months post operatively by the PISQ-12 questionnaire.
Measured: 12 months
Assess sexual quality of life
sexual quality of life assessed at 6 and 12 months post operatively by the ICIQ-FLUTSsex questionnaire.
Measured: 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.
Measured: 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.
Measured: 6 and 12 months
Assess quality of life
Quality of life assessed at 6 and 12 months post operatively by the Qualiveen SF questionnaire.
Measured: 6 and 12 months
Assess complications
Surgical complications assessed at 6 and 12 months post according to the Calvien Dindo.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Artificial Urinary Sphincter ImplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique PHE, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399509
- Sponsor's protocol ID
- APHP251272
- Other IDs
- 2025-A01903-46
- Acronym
- SPHINCTER
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Evaluating the Sexual Function After Insertion of an Artificial Urinary Sphincter in Women
- ClinicalTrials.gov ID
- NCT07399509
- Acronym / sponsor ID
- SPHINCTER / APHP251272
- Keywords
- Artificial urinary sphincter, Urinary Incontinence, Sexual function, Sexual quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have benefited from the surgical implantation of an artificial urinary sphincter
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesThe 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. | Other | – |
Primary outcome
Assess sexual function
Time frame: 6 months
sexual quality of life assessed at 6 months post operatively by the PISQ-12 questionnaire (scale from 0 to 48).
6 secondary outcomes
Assess sexual function
Time frame: 12 months
Assess sexual quality of life
Time frame: 6 and 12 months
Assess urinary incontinence (clinical efficacy)
Time frame: 6 and 12 months
Assess urinary incontinence (clinical efficacy)
Time frame: 6 and 12 months
Assess quality of life
Time frame: 6 and 12 months
Assess complications
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Véronique PHE, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Artificial Urinary Sphincter Implantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique PHE, PU-PH (01.56.01.61.95 ext. +33, veronique.phe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess sexual function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.