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

NCT04416152 | Unknown

• 1 other identifier: 109045-F
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Change of FSFI score

  Change of FSFI score between baseline and after pelvic reconstruction surgery. higher scores mean a or worse outcome.

  1 year

Interventions

Pelvic reconstruction surgery PROCEDURE

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

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with pelvic organ prolapse, who will undergo or had undergo pelvic reconstruction surgeries.

You may qualify if:

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

You may not qualify if:

• Pregnant woman.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+886289667000; smhsiao2@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: May 26, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

TW (1)