CClinicalTrials.gg
Not yet recruitingNCT07690137Updated Jul 9, 2026

Pelvic Floor Symptoms Across Menopausel Stages

An observational study in Menopause and Perimenopausal Disorder, sponsored by Bezmialem Vakif University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Bezmialem Vakif University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
180
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Menopause
  • Perimenopausal Disorder

Keywords

  • Menopausal transition
  • Lower urinary tract symptoms
  • Bowel functions
  • Sexual functions
03

In context

Lower Urinary Tract Symptoms

406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

This study's planned enrollment of 180 is close to the median of 179 across 132 observational studies indexed under Lower Urinary Tract Symptoms.

Browse Lower Urinary Tract Symptoms studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women aged 40-65 years attending the Gynecology and Obstetrics Outpatient Clinic who are classified as perimenopausal, early postmenopausal, or late postmenopausal according to the STRAW+10 criteria. Participants must have an intact uterus and at least one ovary and be able to read and understand Turkish.

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • Perimenopause

    Perimenopausal women according to STRAW+10 criteria

    Other: Assessment for Lower Urinary Tract Symptoms · Other: Assessment for Bowel Symptoms · Other: Constipation Severity Assessment · Other: Sexual Function Assessment

  • Early postmenopause

    Early postmenopausal women according to STRAW+10 criteria

    Other: Assessment for Lower Urinary Tract Symptoms · Other: Assessment for Bowel Symptoms · Other: Constipation Severity Assessment · Other: Sexual Function Assessment

  • Late postmenopause

    Late postmenopausal women according to STRAW+10 criteria

    Other: Assessment for Lower Urinary Tract Symptoms · Other: Assessment for Bowel Symptoms · Other: Constipation Severity Assessment · Other: Sexual Function Assessment

Interventions

  • OtherAssessment 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.

  • OtherAssessment 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.

  • OtherConstipation Severity Assessment

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

  • OtherSexual 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.

06

What researchers measure

Primary outcomes

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

    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

    Time frame: Baseline (single assessment)

Secondary outcomes

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

    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.

    Time frame: Baseline (single assessment)

  2. Cleveland Clinic Constipation Score

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

    Time frame: Baseline (single assessment)

  3. Bristol Stool Form Scale

    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.

    Time frame: Baseline (single assessment)

  4. Female Sexual Function Index

    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.

    Time frame: Baseline (single assessment)

07

Study locations

1 site
  • Bezmialem Vakif University
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07690137
Lead sponsor
Bezmialem Vakif University
Responsible party
Betül Çınar (Associated professor, Bezmialem Vakif University) — Principal investigator
First posted
Jul 8, 2026
Start date
Jul 6, 2026 (estimated)
Primary completion
Sep 6, 2026 (estimated)
Completion
Oct 6, 2026 (estimated)
Last update
Jul 9, 2026

Study contacts

Betul CINAR, PhD
Contact
betulbirik@gmail.com
+905327879969
Betul Cinar, PhD
Contact
bcinar@bezmialem.edu.tr
+90 212 523 22 88 ext. 4649
Betul Cinar, PhD
study chair · Bezmialem Vakif University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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