NCT04336865

Brief Summary

Effect of hormonal contraception on lower urinary tract symptoms\& sexual function

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
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1.4 years

First QC Date

April 4, 2020

Last Update Submit

April 6, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Arabic female sexual function index

    valid questionnaire that can be used in the Egyptian population. The questionnaire is relatively easy to be understood by lay women and does not contain unacceptably sexually explicit questions, which may pose difficulties for self-rating. ArFSf I is valid and reliable,and it is as good as the original FSFI in assessing female sexual function \&good psychometric tool for sexual dysfunction . Research in the area of female sexuality is not easy and relatively challenging in the Arab world

    baseline

  • Bristol female lower urinary tract symptoms questionnaire

    it was designed to asses lower urinary tract symptoms in women \& quality of sexual life . it will be translated into arabic language

    baseline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

all women attending family planning clinic taking hormonal contraception

You may qualify if:

  • Women taking hormonal contraception e.g cocs .pops.implanon\&.injectable contraception
  • Women has good regular marital life

You may not qualify if:

  • female has organic urinary dysfunction
  • female has mental\& psycological dysfunction
  • chronic disease DM.hypertension. chronic renal disease
  • prolapse
  • previous perineal \&vaginal correlation surgery
  • women taking any treatment for urinary tract infection \&sexual dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women"S Health Hospital

Asyut, Egypt

Location

Related Publications (3)

  • Batra SC, Iosif CS. Progesterone receptors in the female lower urinary tract. J Urol. 1987 Nov;138(5):1301-4. doi: 10.1016/s0022-5347(17)43588-9.

    PMID: 3669191BACKGROUND
  • Champaneria R, D'Andrea RM, Latthe PM. Hormonal contraception and pelvic floor function: a systematic review. Int Urogynecol J. 2016 May;27(5):709-22. doi: 10.1007/s00192-015-2833-3. Epub 2015 Sep 25.

    PMID: 26407563BACKGROUND
  • de Castro Coelho F, Barros C. The Potential of Hormonal Contraception to Influence Female Sexuality. Int J Reprod Med. 2019 Mar 3;2019:9701384. doi: 10.1155/2019/9701384. eCollection 2019.

    PMID: 30941356BACKGROUND

Study Officials

  • muhmoud zakhera

    Assiut University

    STUDY CHAIR
  • mostafa bahlool

    Assiut University

    STUDY CHAIR

Central Study Contacts

randa habeeb yacoup

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 7, 2020

Study Start

April 15, 2020

Primary Completion

September 15, 2021

Study Completion

October 15, 2021

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations