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NCT01387685 Clinical Trial

Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh

Pelvic Floor Prolapse Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01387685
Other study ID # 920090042
Secondary ID
Status Withdrawn
Phase N/A
First received June 29, 2011
Last updated June 19, 2014
Start date February 2009
Est. completion date January 2013

Study information
Verified date June 2014
Source Western Galilee Hospital-Nahariya
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- Women who underwent surgery for pelvic floor prolapse

Exclusion Criteria:

- Women who did not have surgery for pelvic floor prolapse.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Department of Obstetrics and Gynecology, Western Galilee Hospital Nahariya
Israel Dr Neuman clinic Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Satisfaction with study outcome six to twelve months after surgery No
Secondary Side effects of the surgery: pain, vaginal erosion by tape, bleeding Within six to twelve months after study Yes
See also
  Status Clinical Trial Phase
Completed NCT03387202 - Laparoscopic Lateral Mesh Suspension for Pelvic Organ Prolapse N/A
Not yet recruiting NCT04393194 - The Effect of Intra-vaginal Conjugated Estrogen Cream on Ring Pessary Use for Pelvic Organ Prolapse Phase 4
Recruiting NCT04428320 - The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery N/A
Completed NCT02680145 - Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use N/A
Recruiting NCT04547816 - Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse Phase 3
Completed NCT03421457 - Laparoscopic Lateral Suspension With Mesh & Sacrocervicopexy for the Treatment of Uterine Prolapse N/A
Completed NCT01392417 - Anterior Prolift Versus Posterior Prolift for Pelvic Floor Prolapse N/A
Withdrawn NCT01383291 - Prolift Versus IVS for Pelvic Floor Prolapse N/A