Clinical Trials Logo
  1. Home
  2. Cystocele
  3. NCT03056586
  4. Details
NCT03056586 Clinical Trial

The Effect of Pessary Post Vaginal Prolapse Repair, for One Month, to Reduce the Recurrence Rate of Prolapse

Cystocele Clinical Trial

— pfgp  

Official title:
The Recurrence Rate of Genital Prolapse Post Repair With the Use of PESSARY for One Month Post Operative

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03056586
Other study ID # 0188-16-MMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 15, 2017
Last updated March 6, 2017
Start date March 20, 2017
Est. completion date December 20, 2019

Study information
Verified date March 2017
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Genital prolapse is a common complain. 30-40% of women will complain of uterine prolapse or cystocele or rectocele, or mixed. About half of them will require surgical repair for the prolapse, with or without hysterectomy. Of these patients about 30-40% will have recurrence of the prolapse, which in some cases requires second operation.

In this study the investigators want to investigate whether a vaginal pessary inserting in the end of the primary surgery, for 4 weeks, will reduce the recurrence rate.

Description:

All patients going for vaginal surgery for genital prolapse, stage 3-4, with cystocele, rectocele or uterine cervix prominent from the vagina. These patients, after signing an informed consent, a vaginal pessary will insert at the end of the operation and will stay for 4 weeks post-op.

After 4 weeks the pessary will be removed, and the patient will followed for 2 years, for recurrence of prolapse.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 20, 2019
Est. primary completion date December 20, 2018
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- all healthy patients with genital prolapse grade 3-4, going for vaginal surgery

- age 30-80years

Exclusion Criteria:

- patients with pelvic inflammatory disease

- patients after pelvic irradiation

- large vaginal erosion

- vaginal bleeding uncontrolled or undiagnosed

- patients going for surgery with mesh

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• vaginal pessary
A vaginal pessary will be inserted at the end of the operation, for genital prolapse, and will be sutured to the vaginal wall. The pessary will stay in the vagina for 4 weeks.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of recurrence rate of vaginal prolapse, post vaginal surgery repair. The investigators hope to see a low percentage of prolapse recurrence in the study (pessary) group, comparing to the control (no pessary) group 24 month
See also
  Status Clinical Trial Phase
Completed NCT01637441 - Prosthetic Pelvic Organ Prolapse Repair N/A
Recruiting NCT04009694 - Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse? N/A
Completed NCT04481906 - Vaginal Mesh Procedures for Female Cystocele
Completed NCT02888093 - A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension N/A
Completed NCT02272361 - Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair. N/A
Completed NCT02255994 - UGYTEX® Mesh Versus Subvesical Plication in the Surgical Treatment of Bladder Prolapse N/A
Withdrawn NCT00942474 - Nerve Access Tool Study N/A
Completed NCT04417413 - Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.
Active, not recruiting NCT03714607 - Laser Therapy in Managing Vaginal Prolapse N/A
Completed NCT04184128 - Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele
Active, not recruiting NCT01097200 - Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse N/A
Recruiting NCT00162604 - Prophylactic Antibiotic Treatment During Vaginal Repair N/A
Completed NCT02400034 - Comparing Voiding Trials After Midurethral Sling for Stress Incontinence N/A
Completed NCT01559558 - Changes of Pad Weight Results and Urethral Pressure Profiles After Reduction of Cystocele by Vaginal Gauze Packing N/A
Active, not recruiting NCT02272322 - Transvaginal Treatment of Symptomatic Cystocele Grade II-III N/A
Completed NCT00557882 - Efficacy Study of Vaginal Mesh for Anterior Prolapse Phase 4
Completed NCT04175782 - Enhanced Recovery Protocol in Urogynecologic Surgery N/A
Recruiting NCT05449054 - Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy N/A
Recruiting NCT05688059 - Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension N/A
Active, not recruiting NCT02231099 - Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery N/A