Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function

Pelvic Organ Prolapse Clinical Trial

Official title:

Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416152
• Other study ID #: 109045-F
• Status: Recruiting
• Start date: May 26, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Far Eastern Memorial Hospital
• Contact: Sheng-Mou Hsiao, MD
• Phone: +886289667000
• Email: smhsiao2[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms, psychological distress and sexual function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Women with pelvic organ prolapse, who will undergo pelvic reconstruction surgery
• Women who had undergone pelvic reconstruction surgeries in our hospital

Exclusion Criteria:

• Pregnant woman.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Pelvic reconstruction surgery
Pelvic reconstruction surgeries, such as anterior/posterior colporrhaphy, sacrospinous ligament fixation, transvaginal mesh repair and sacrocolpopexy.

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the women's bladder function questionnaire of UDI-6	Change of UDI-6 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.	10 years
Primary	the women's bladder function questionnaire of IIQ-7	Change of IIQ-7 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.	10 years
Primary	Change of psychosomatic score	Change of psychosomatic score between baseline and after pelvic reconstruction surgery, and higher scores mean a or worse outcome.	1 year
Primary	Change of Overactive Bladder Symptom Score	Change of OABSS score between baseline and after pelvic reconstruction surgery. Score values 0-15, and higher scores mean a or worse outcome.	1 year
Primary	Change of FSFI score	Change of FSFI score between baseline and after pelvic reconstruction surgery. higher scores mean a or worse outcome.	1 year