Skip to main content
OpenTrials
Completed

NCT Number: NCT04515888

Evaluation of the Prevalence of Pelvic Static Disorders in Women With Localized Breast Cancer

In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

About this study

Breast cancer is the most common cancer in women. Its incidence increases with 58,459 new cases in France in 2018, however its mortality decreases with a survival rate of 87% at 5 years.

Therapeutic options are surgery, radiotherapy, chemotherapy and hormone therapy. Hormone therapy is one of the major treatments for hormone-sensitive tumors with a prescription made in around 70% of breast cancer cases. These different hormone therapies cause a hormonal imbalance with in particular an important anti-estrogenic action. Hormonal deprivation and menopause can be responsible for the occurrence of pelvic statics disorder.[5-9] Pelvic static disorder (PTS) is a common problem for women, which can occur at any age.

These disorders include urinary incontinence, stress or urgency, anal incontinence, genital prolapse.

Hypothesis's investigator is that hormone therapy may be responsible for PTS. In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with Age ≥ 50 years
  • Menopaused
  • Patient followed for carcinoma in situ or infiltrating the breast with or without hormone therapy
  • Patient who was treated by surgery after June 2015, whether or not followed by radiotherapy or chemotherapy.
  • Patient who agreed, after receiving information, to participate to the study.

Exclusion criteria

  • Metastatic breast cancer
  • Patient with a history of pelvic static surgery
  • Patient with a history of pelvic irradiation
  • Patient unable or unwilling to complete the questionnaires
  • Patient with a history of urinary incontinence treatment
  • Patient not affiliated to the French social security system
  • Subject under tutelage, curatorship or safeguard of justice,
  • Patient in an emergency situation,
  • Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
  • Pregnant and / or breastfeeding woman.

Treatment and study plan

PFDI-20 / PFIQ-7 questionnaires

Other

PFDI-20 / PFIQ-7 questionnaires (one shot)

Primary outcomes

  1. Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).

    Time frame: Day 1

    Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients (hormonotherapy +)

Secondary outcomes

  1. Evaluate the prevalence of pelvic static disorders in patients (hormonotherapy -)

    Time frame: Day 1

    Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy -

  2. Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy +

    Time frame: Day 1

    Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy - and patient hormontherapy +

  3. Evaluate the impact of pelvic static disorders on quality of life

    Time frame: Day 1

    Estimation of quality of life according to the PFIQ-7 (Pelvic Floor Impact Questionnaire) in the 2 populations. the total score of the PFIQ-7 is obtained by adding the scores for each scale (between 0 (no impact) and 300 (maximum impact))

  4. Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups

    Time frame: Day 1

    Estimation of pelvic symptoms scores according to the PFDI-20 (Pelvic Floor Distress Inventory) questionnaire in the 2 populations. the total score of the PFDI-20 is obtained by adding the scores for each scale (between 0 (no impact) and 300 (maximum impact))

  5. Evaluate the correlation between hormone therapy and pelvic static disorders

    Time frame: Day 1

    Estimate the Rational rate between pelvic static disorders and hormone therapy with adjustment on known parameters : age, obesity, type of birth (vaginal or caesarean)

  6. Research the risk factors for pelvic static disorders

    Time frame: Day 1

    number of risk factors based on data collected

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.

Acronym: STATICBREAST

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2020
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.