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NCT Number: NCT07690137

Pelvic Floor Symptoms Across Menopausel Stages

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.

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Key information

Conditions

Menopause Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Perimenopausal Disorder Signs and Symptoms Urological Manifestations

Age range

40 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Assessment for Lower Urinary Tract Symptoms

Other

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.

Assessment for Bowel Symptoms

Other

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.

Constipation Severity Assessment

Other

Constipation severity will be assessed using the Cleveland Clinic Constipation Score. Higher scores represent more severe constipation symptoms.

Sexual Function Assessment

Other

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 outcomes

  1. Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score

    Time frame: Baseline (single assessment)

    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

Secondary outcomes

  1. Colorectal Anal Distress Inventory-8 (CRADI-8)

    Time frame: Baseline (single assessment)

    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.

  2. Cleveland Clinic Constipation Score

    Time frame: Baseline (single assessment)

    Constipation severity will be assessed using the Cleveland Clinic Constipation Score. Higher scores represent more severe constipation symptoms.

  3. Bristol Stool Form Scale

    Time frame: Baseline (single assessment)

    The Bristol Stool Form Scale is a 7-category scale ranging from Type 1 (hard stools) to Type 7 (watery stools). Values range from 1 to 7. Lower scores indicate harder stool consistency, whereas higher scores indicate looser stool consistency.

  4. Female Sexual Function Index

    Time frame: Baseline (single 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Betul CINAR, PhD

CONTACT

[email protected]

+905327879969

Betul Cinar, PhD

CONTACT

[email protected]

+90 212 523 22 88 ext. 4649

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 9, 2026

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.

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