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

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04416152
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 43.2
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Pelvic reconstruction surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function
• Actual Study Start Date: May 26, 2020
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Change of UDI-6 score [10 years]

   Change of UDI-6 score between baseline and after pelvic reconstruction surgery

2. Change of IIQ-7 score [10 years]

   Change of IIQ-7 score between baseline and after pelvic reconstruction surgery

3. Change of psychosomatic score [1 year]

   Change of psychosomatic score between baseline and after pelvic reconstruction surgery

4. Change of OABSS score [1 year]

   Change of OABSS score between baseline and after pelvic reconstruction surgery

5. Change of FSFI score [1 year]

   Change of FSFI score between baseline and after pelvic reconstruction surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Far Eastern Memorial Hospital	Banqiao	New Taipei	Taiwan	22050

Sponsors and Collaborators

• Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04416152
• Other Study ID Numbers: 109045-F
• First Posted: Jun 4, 2020
• Last Update Posted: Jun 4, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse; Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Jun 4, 2020