Urinary IncontinenceNCT02306655
Coital Incontinence: Incidence and Quality of Life Impact.
An observational study of Urinary Incontinence and Quality of Life, run by University of Roma La Sapienza at 2 sites in Italy.
Trial summary
Fundamentals of scientific research The "coital incontinence" (IC), defined as the "involuntary loss of urine in association with sexual intercourse." The incidence reported in the literature ranges from 10% to 27%, but is likely to be underestimated because of the embarrassment of the woman to report the disturbance. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Quality of Life, Coitus
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients with sexual activity and with stable relationship for at least six months
Who may be able to join
- Female patients with age > 18 y.o. Stable relationship for at least 6 months At least one sexual intercourse every 2 weeks
Who cannot join
- Male patients Female patients aged < 18 y.o. Patients without a stable relationship or with no sexual activity (as defined for at least one sexual intercourse every 2 weeks)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Urology Unit, Sapienza University of Rome
Latina, 04100
Antonio Carbone, Prof, MD, antonio.carbone@uniroma1.it
Antonio Luigi Pastore, MD, PhD
- Recruiting
Urogynecology Unit, Urology Clinic, University of Perugia
Perugia, 06131
Elisabetta Costantini, Professor, +390755783743, elisabetta.costantini@unipg.it
Elisabetta Costantini, MD, Prof
About this study
Fundamentals of scientific research The "coital incontinence" (IC), defined as the "involuntary loss of urine in association with sexual intercourse." The incidence reported in the literature ranges from 10% to 27%, but is likely to be underestimated because of the embarrassment of the woman to report the disturbance. It was in fact estimated that only 3% of women speaks spontaneously to their doctor, and increases up to 20% only after a request by the medical staff.
The CI is traditionally divided into two forms:
Read more
- incontinence at the time of penetration (60% of cases)
- incontinence during orgasm (40% of cases) Many theories have been proposed to justify this form of urinary incontinence, but none has been conclusively proved .Moreover, it has not been possible, to date, to identify risk factors, anatomical or urodynamics, for this condition.
The IC is rarely a symptom isolated, but more frequently associated with other forms of urinary incontinence. In particular, the IC during penetration of associated with stress urinary incontinence (loss of urine that occurs due to coughing, sneezing and in general to all those activities that increase abdominal pressure); the IC during orgasm is associated more frequently to a condition of overactive bladder (presence of urgency, urge incontinence, increased urination day and night).
The IC has a strong impact on female sexuality and can cause loss of libido, non orgasmic, decreased sexual satisfaction and, in some cases, termination of sexual activity.
Research goals Evaluate a prospective investigation of health statistics, the incidence of coital incontinence into consideration that there are few data in the literature on this disorder and those who have reported a wide variance probably connected to how the data collection. The aim is to be able to identify a "threatening condition" which, if not evaluated, worsens the prognosis of the treatment of female urinary incontinence, a condition that has a negative impact on the quality of life of patients with significantly worse than that related to other recognized debilitating chronic diseases such as diabetes.
And this individual psychosocial cost, hardly quantifiable, must be added the cost of significant socio-economic and welfare dependents of incontinent patients, the community and national health services. It is indeed evident from international and national literature that the more incisive and determined is the strategy of information, awareness and education, and adopted much wider and earlier the diagnosis, the more significant is the socio-economic savings, as well as psycho social, we get.
Ultimate goal is to differentiate between them the two forms of incontinence coital (to penetration and during orgasm) because each of them is associated with pathogenesis and therefore to a separate treatment. And while the forms of IC penetration favorably affected the treatment of stress urinary incontinence, the forms of IC during orgasm, usually associated with a functional disorder of the detrusor (detrusor overactivity) show an inferior efficacy to treatment antimuscarinic traditionally reserved to the condition of overactive bladder and therefore need a more targeted diagnostic and individualized treatments.
Materials and methods
Self administered questionnaires will be dispensed to the patients The questionnaires,validated in Italian language, will be used, according to the guidelines of the International Consultation on Incontinence, :
- ICIQ-UI on urinary incontinence short-form: for the evaluation of symptoms and quality of life:
- Patient Perception of Bladder Condition (PPBC): to assess the impact of such a subjective condition;
- Urinary incontinence and quality of sexuality;
- Urinary incontinence and frequency of sexual activity; The questionnaire is anonymous in order to protect privacy. The patients will be recruited at the outpatient surgery and Urogynaecology urodynamics of Urology Clinic of the University of Perugia.
The investigators defined that the statistically significant number of subjects can not be less than 200 units.
The time duration of the collection of medical records was estimated at two years.
There are no extremes of the conflict of interest, will not be tested or used drugs or medical equipment.
- Conditions
- Urinary Incontinence, Quality of Life, Coitus
- Keywords
- Coital incontinence, Incidence, quality of life
- Medical subject headings
- Urinary Incontinence, Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life evaluation in patients with coital incontinence
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- University Of Perugia
- Responsible party
- Principal investigator, Antonio Luigi Pastore, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306655
- Sponsor's protocol ID
- University of Perugia
- Status last verified
- Dec 2014
- First submitted
- 29 Nov 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coital Incontinence: Incidence and Quality of Life Impact.
- ClinicalTrials.gov ID
- NCT02306655
- Acronym / sponsor ID
- University of Perugia
- Conditions
- Urinary Incontinence, Quality of Life, Coitus
- Keywords
- Coital incontinence, Incidence, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- University Of Perugia
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- 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.
Fundamentals of scientific research The "coital incontinence" (IC), defined as the "involuntary loss of urine in association with sexual intercourse." The incidence reported in the literature ranges from 10% to 27%, but is likely to be underestimated because of the embarrassment of the woman to report the disturbance. It was in fact estimated that only 3% of women speaks spontaneously to their doctor, and increases up to 20% only after a request by the medical staff.
The CI is traditionally divided into two forms:
- incontinence at the time of penetration (60% of cases)
- incontinence during orgasm (40% of cases) Many theories have been proposed to justify this form of urinary incontinence, but none has been conclusively proved .Moreover, it has not been possible, to date, to identify risk factors, anatomical or urodynamics, for this condition.
The IC is rarely a symptom isolated, but more frequently associated with other forms of urinary incontinence. In particular, the IC during penetration of associated with stress urinary incontinence (loss of urine that occurs due to coughing, sneezing and in general to all those activities that increase abdominal pressure); the IC during orgasm is associated more frequently to a condition of overactive bladder (presence of urgency, urge incontinence, increased urination day and night).
The IC has a strong impact on female sexuality and can cause loss of libido, non orgasmic, decreased sexual satisfaction and, in some cases, termination of sexual activity.
Research goals Evaluate a prospective investigation of health statistics, the incidence of coital incontinence into consideration that there are few data in the literature on this disorder and those who have reported a wide variance probably connected to how the data collection. The aim is to be able to identify a "threatening condition" which, if not evaluated, worsens the prognosis of the treatment of female urinary incontinence, a condition that has a negative impact on the quality of life of patients with significantly worse than that related to other recognized debilitating chronic diseases such as diabetes.
And this individual psychosocial cost, hardly quantifiable, must be added the cost of significant socio-economic and welfare dependents of incontinent patients, the community and national health services. It is indeed evident from international and national literature that the more incisive and determined is the strategy of information, awareness and education, and adopted much wider and earlier the diagnosis, the more significant is the socio-economic savings, as well as psycho social, we get.
Ultimate goal is to differentiate between them the two forms of incontinence coital (to penetration and during orgasm) because each of them is associated with pathogenesis and therefore to a separate treatment. And while the forms of IC penetration favorably affected the treatment of stress urinary incontinence, the forms of IC during orgasm, usually associated with a functional disorder of the detrusor (detrusor overactivity) show an inferior efficacy to treatment antimuscarinic traditionally reserved to the condition of overactive bladder and therefore need a more targeted diagnostic and individualized treatments.
Materials and methods
Self administered questionnaires will be dispensed to the patients The questionnaires,validated in Italian language, will be used, according to the guidelines of the International Consultation on Incontinence, :
- ICIQ-UI on urinary incontinence short-form: for the evaluation of symptoms and quality of life:
- Patient Perception of Bladder Condition (PPBC): to assess the impact of such a subjective condition;
- Urinary incontinence and quality of sexuality;
- Urinary incontinence and frequency of sexual activity; The questionnaire is anonymous in order to protect privacy. The patients will be recruited at the outpatient surgery and Urogynaecology urodynamics of Urology Clinic of the University of Perugia.
The investigators defined that the statistically significant number of subjects can not be less than 200 units.
The time duration of the collection of medical records was estimated at two years.
There are no extremes of the conflict of interest, will not be tested or used drugs or medical equipment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with sexual activity and with stable relationship for at least six months
Key inclusion criteria (1 listed)
- Female patients with age > 18 y.o. Stable relationship for at least 6 months At least one sexual intercourse every 2 weeks
Key exclusion criteria (1 listed)
- Male patients Female patients aged < 18 y.o. Patients without a stable relationship or with no sexual activity (as defined for at least one sexual intercourse every 2 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life evaluation in patients with coital incontinence
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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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. This study is not recruiting at the moment.
Urogynecology Unit, Urology Clinic, University of Perugia
Perugia, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Quality of Life, run by University of Roma La Sapienza at 2 sites in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life evaluation in patients with coital incontinence (time frame: 24 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 4 Dec 2014.