- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07690137
Pelvic Floor Symptoms Across Menopausel Stages
Comparison of Lower Urinary Tract Symptoms, Bowel Function, and Sexual Health Across Menopausal Stages in Women
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Betul CINAR, PhD
- 전화번호: +905327879969
- 이메일: betulbirik@gmail.com
연구 연락처 백업
- 이름: Betul Cinar, PhD
- 전화번호: 4649 +90 212 523 22 88
- 이메일: bcinar@bezmialem.edu.tr
연구 장소
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-
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Istanbul, 터키 (Türkiye)
- Bezmialem Vakif University
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연락하다:
- Betul Cinar, PhD
- 전화번호: 4649 +90 212 523 22 88
- 이메일: bcinar@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Perimenopause
Perimenopausal women according to STRAW+10 criteria
|
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.
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 will be assessed using the Cleveland Clinic Constipation Score.
Higher scores represent more severe constipation symptoms.
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
Early postmenopausal women according to STRAW+10 criteria
|
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.
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 will be assessed using the Cleveland Clinic Constipation Score.
Higher scores represent more severe constipation symptoms.
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.
|
|
Late postmenopause
Late postmenopausal women according to STRAW+10 criteria
|
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.
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 will be assessed using the Cleveland Clinic Constipation Score.
Higher scores represent more severe constipation symptoms.
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bristol Female Lower Urinary Tract Symptoms (BFLUTS) Score
기간: 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
|
Baseline (single assessment)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Colorectal Anal Distress Inventory-8 (CRADI-8)
기간: 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.
|
Baseline (single assessment)
|
|
Cleveland Clinic Constipation Score
기간: Baseline (single assessment)
|
Constipation severity will be assessed using the Cleveland Clinic Constipation Score.
Higher scores represent more severe constipation symptoms.
|
Baseline (single assessment)
|
|
Female Sexual Function Index
기간: 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.
|
Baseline (single assessment)
|
|
Bristol Stool Form Scale
기간: 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.
|
Baseline (single assessment)
|
공동 작업자 및 조사자
수사관
- 연구 의자: Betul Cinar, PhD, Bezmialem Vakif University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- bvubcinar05
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