Health TrialsbyHealthPanel

Pelvic Floor Symptoms Across Menopausel Stages

ConditionsMenopausePerimenopausal Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-65
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Age 40-65 years

Intact uterus and at least one ovary

Perimenopause or postmenopause according to STRAW+10 criteria

Disqualifiers

Hormone replacement therapy within the previous 6 months

Oral contraceptive use

Antipsychotic medication use

Previous pelvic surgery

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Assessment for Lower Urinary Tract Symptoms

    Other intervention

    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 intervention

    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 intervention

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

  • Sexual Function Assessment

    Other intervention

    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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Perimenopause4 interventions
Group B: Early postmenopause4 interventions
Group C: Late postmenopause4 interventions

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bezmialem Vakif University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: