NCT02306655

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

November 29, 2014

Last Update Submit

December 3, 2014

Conditions

Keywords

Coital incontinenceIncidencequality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life evaluation in patients with coital incontinence

    24 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (2)

Urology Unit, Sapienza University of Rome

Latina, 04100, Italy

RECRUITING

Urogynecology Unit, Urology Clinic, University of Perugia

Perugia, 06131, Italy

RECRUITING

MeSH Terms

Conditions

Urinary IncontinenceCoitus

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

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

Locations