Coital Incontinence: Incidence and Quality of Life Impact.
1 other identifier
observational
200
1 country
2
Brief 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. 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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 29, 2014
CompletedFirst Posted
Study publicly available on registry
December 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedDecember 4, 2014
December 1, 2014
1.1 years
November 29, 2014
December 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life evaluation in patients with coital incontinence
24 months
Eligibility Criteria
Female patients with sexual activity and with stable relationship for at least six months
You may qualify if:
- Female patients with age \> 18 y.o. Stable relationship for at least 6 months At least one sexual intercourse every 2 weeks
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Roma La Sapienzalead
- University Of Perugiacollaborator
Study Sites (2)
Urology Unit, Sapienza University of Rome
Latina, 04100, Italy
Urogynecology Unit, Urology Clinic, University of Perugia
Perugia, 06131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Assistant Professor
Study Record Dates
First Submitted
November 29, 2014
First Posted
December 3, 2014
Study Start
October 1, 2014
Primary Completion
November 1, 2015
Study Completion
June 1, 2016
Last Updated
December 4, 2014
Record last verified: 2014-12