Pelvic Floor Symptoms Across Menopausel Stages

NCT07690137 | Not Yet Recruiting

• 1 other identifier: bvubcinar05
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Perimenopausal Disorder

Keywords

Menopausal transition; Lower urinary tract symptoms; Bowel functions; Sexual functions

Outcome Measures

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

  Baseline (single assessment)

Secondary Outcomes (4)

• Colorectal Anal Distress Inventory-8 (CRADI-8)

  Baseline (single assessment)

• Cleveland Clinic Constipation Score

  Baseline (single assessment)

• Bristol Stool Form Scale

  Baseline (single assessment)

• Female Sexual Function Index

  Baseline (single assessment)

Study Arms (3)

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

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.

Early postmenopause; Late postmenopause; Perimenopause

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.

Early postmenopause; Late postmenopause; Perimenopause

Constipation Severity Assessment OTHER

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

Early postmenopause; Late postmenopause; Perimenopause

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.

Early postmenopause; Late postmenopause; Perimenopause

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Betul Cinar, PhD

  Bezmialem Vakif University

  STUDY CHAIR

Central Study Contacts

Betul CINAR, PhD

CONTACT

+905327879969; betulbirik@gmail.com

Betul Cinar, PhD

CONTACT

+90 212 523 22 88; bcinar@bezmialem.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

TU (1)