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NCT02599311 Clinical Trial

the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

Pelvic Organ Prolapse Clinical Trial

Official title:
The Clinical Efficacy of Pelvic Organ Prolapse Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02599311
Other study ID # PKUPH
Secondary ID
Status Recruiting
Phase Phase 3
First received November 1, 2015
Last updated May 21, 2017
Start date August 2015
Est. completion date October 2020

Study information
Verified date May 2017
Source Peking University People's Hospital
Contact Xiuli Sun, professor
Phone 861088324354
Email zzucaotingting@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

One thousand patients with stage＞2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Postoperatively, the investigators investigate the indications and clinical efficacy of pelvic organ prolapse surgery.

Description:

Postoperatively, the investigators analyze the patients' subjective and objective recurrent rates. The investigators compare the quality of life by filling out the preoperative and postoperative scoring questionnaires (PISQ 12, PFDI-20, PFIQ-7).The electrical physiological changes will be focused on. The investigators also use Overactive Bladder Symptom Score(OABss) to assess the lower urinary tract symptoms.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date October 2020
Est. primary completion date October 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- The patients with stage>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.

Exclusion Criteria:

- The patients with POP who have not undergone surgery are excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• transvaginal synthetic mesh
transvaginal synthetic mesh
Drug:
• Tolterodine
Tolterodine tartrate can improve patients' LUTS.

Locations
Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary the objective recurrent rate The objective recurrence means postoperative stage=2 (POP-Q) in any compartment. one year after surgery
Secondary the rate of the lower urinary tract symptoms We focus on lower urinary tract symptoms (LUTS), including frequent micturition, urgent urination, cough (or sneezing) leakage, dysuria, and urinary incontinence. one year after surgery
Secondary the quality of life questionnaires The QOL questionnaires include PFDI-20 and PFIQ-7. one year after surgery
See also
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Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
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Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Recruiting NCT02919852 - Laparoscopic Retrovesical Colpopectinopexia N/A
Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A