Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00475540
Other study ID # 2006-232
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2007
Est. completion date August 2013

Study information

Verified date July 2022
Source Medstar Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.


Description:

Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 2013
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria: - Woman > 21 yrs - Stage II-IV vaginal prolapse - Desires vaginal reconstructive surgery - Able to complete study questionnaires and assessments - Uterus < 12 weeks size - Available for 12 months follow-up Exclusion Criteria: - Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system. - Current intermittent catheterization. - Pregnancy or desire for future fertility. - Presence of an adnexal mass. - Shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys). - Other laparoscopic or abdominal/pelvic surgery in the past 3 months. - Known neurologic or medical condition affecting bladder function, e.g. Multiple Sclerosis, spinal cord injury. - Need for concomitant surgery requiring an abdominal incision. - < 12 months post-partum. - Non-english speaking

Study Design


Intervention

Device:
synthetic monofilament polypropylene mesh
Vaginal prolapse repair with mesh

Locations

Country Name City State
United States Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Anatomic Cure at 3 Years 3 different measures for Anatomic cure using POPQ measurements:
POP-Q at Stage I or less* (POP-Q points Ba, Bp or C -1 or less);
no prolapse beyond the hymen (Ba, Bp or C 0 or less);
no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no.
Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better
3 year
Secondary Bothersome Dyspareunia Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia 3 year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
Active, not recruiting NCT05422209 - The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. N/A
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT06126328 - Materna Prep Study Phase II Phase 2
Recruiting NCT05542836 - EVeRLAST 2-Year Follow-Up
Recruiting NCT05918367 - Multicenter Ventral Mesh Rectopexy Registry Collaborative
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 NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Recruiting NCT02919852 - Laparoscopic Retrovesical Colpopectinopexia 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
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring 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