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Not yet recruiting NCT07690137

Pelvic Floor Symptoms Across Menopausel Stages

— Observational Menopause Perimenopausal Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment for Lower Urinary Tract Symptoms, Assessment for Bowel Symptoms, Constipation Severity Assessment, Sexual Function Assessment.
Who it may be relevant to
Registry conditions: Menopause, Perimenopausal Disorder. Basic parameters: 40 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Lower Urinary Tract Symptoms, Bowel Function, and Sexual Health Across Menopausal Stages in Women

Overview

The menopausal transition is associated with substantial hormonal alterations that may adversely affect lower urinary tract function, bowel function, and sexual health. Although these symptoms are common, few studies have comprehensively evaluated all three pelvic floor compartments across different menopausal stages. The aim of this study is to compare lower urinary tract symptoms, bowel symptoms, and female sexual function among women in the perimenopausal, early postmenopausal, and late postmenopausal stages. In addition, the relationship between menopausal stage and symptom severity will be investigated.

Detailed description

Menopause is characterized by estrogen deficiency, resulting in structural and functional alterations in pelvic floor tissues. Lower urinary tract symptoms, bowel dysfunction, and female sexual dysfunction are increasingly recognized as important health concerns during the menopausal transition.

Despite growing evidence regarding individual pelvic floor disorders, few studies have simultaneously evaluated urinary, colorectal, and sexual symptoms across different menopausal stages.

This study will classify women according to STRAW+10 criteria into:

Perimenopause Early postmenopause Late postmenopause

Participants will undergo a single assessment session. Demographic information together with validated questionnaires will be collected. No intervention or treatment will be provided.

Interventions

  • Other Assessment for Lower Urinary Tract Symptoms
    Lower urinary tract symptoms will be assessed using the validated Bristol Female Lower Urinary Tract Symptoms questionnaire. Higher scores indicate greater symptom severity and poorer urinary health-related quality of life.
  • Other Assessment for Bowel Symptoms
    Bowel symptoms and colorectal-anal distress will be evaluated using the Colorectal Anal Distress Inventory-8. Higher scores indicate greater symptom severity and distress related to bowel dysfunction.
  • Other Constipation Severity Assessment
    Constipation severity will be assessed using the Cleveland Clinic Constipation Score. Higher scores represent more severe constipation symptoms.
  • Other Sexual Function Assessment
    Female sexual function will be assessed using the Female Sexual Function Index, a validated questionnaire evaluating desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate better sexual function.

Primary outcome measures

  • Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score [Time frame: Baseline (single assessment)]
Secondary outcome measures (4)
  • Colorectal Anal Distress Inventory-8 (CRADI-8) [Time frame: Baseline (single assessment)]
  • Cleveland Clinic Constipation Score [Time frame: Baseline (single assessment)]
  • Bristol Stool Form Scale [Time frame: Baseline (single assessment)]
  • Female Sexual Function Index [Time frame: Baseline (single assessment)]

Eligibility criteria

Inclusion criteria

  • Female
  • Age 40-65 years
  • Intact uterus and at least one ovary
  • Perimenopause or postmenopause according to STRAW+10 criteria
  • Able to read and understand Turkish

Exclusion criteria

  • Hormone replacement therapy within the previous 6 months
  • Oral contraceptive use
  • Antipsychotic medication use
  • Previous pelvic surgery
  • Neurological or systemic diseases affecting bladder or bowel function
  • Active urinary tract or vaginal infection
  • Pelvic radiotherapy or chemotherapy history
  • Active gynecological or urological malignancy
  • Alcohol or substance abuse during the previous year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Bezmialem Vakif University — Istanbul

Identifiers

NCT: NCT07690137 · bvubcinar05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗