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Pelvic Floor Symptoms Across Menopausel Stages

NCT07690137 — Not yet recruiting, 180 participants, Bezmialem Vakif University

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

RegistryNCT07690137
StatusNot yet recruiting
Study typeObservational
Enrollment180 (Estimated)
SponsorBezmialem Vakif University (Other)
ConditionsMenopause, Perimenopausal Disorder
InterventionsAssessment for Lower Urinary Tract Symptoms, Assessment for Bowel Symptoms, Constipation Severity Assessment, Sexual Function Assessment (Other)
Datesstart 2026-07-06 (estimated), primary completion 2026-09-06 (estimated), completion 2026-10-06 (estimated), first posted 2026-07-08, last updated 2026-07-09
Locations1 site in Turkey (Türkiye)

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-Summary

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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+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.

+Arms and interventions

ArmTypeInterventionsDescription
PerimenopauseOther: Assessment for Lower Urinary Tract Symptoms; Other: Assessment for Bowel Symptoms; Other: Constipation Severity Assessment; Other: Sexual Function AssessmentPerimenopausal women according to STRAW+10 criteria
Early postmenopauseOther: Assessment for Lower Urinary Tract Symptoms; Other: Assessment for Bowel Symptoms; Other: Constipation Severity Assessment; Other: Sexual Function AssessmentEarly postmenopausal women according to STRAW+10 criteria
Late postmenopauseOther: Assessment for Lower Urinary Tract Symptoms; Other: Assessment for Bowel Symptoms; Other: Constipation Severity Assessment; Other: Sexual Function AssessmentLate postmenopausal women according to STRAW+10 criteria
  • 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.

+Outcome measures

Primary outcomes

  • Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score [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

  • Colorectal Anal Distress Inventory-8 (CRADI-8) [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.
  • Cleveland Clinic Constipation Score [Baseline (single assessment)]: Constipation severity will be assessed using the Cleveland Clinic Constipation Score. Higher scores represent more severe constipation symptoms.
  • Bristol Stool Form Scale [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.
  • Female Sexual Function Index [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.

+Eligibility

Sex: Female, ages: 40 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
Bezmialem Vakif UniversityIstanbulTurkey (Türkiye)

+Investigators

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