Clinical Trials Logo

Pelvic Organ Prolapse clinical trials

View clinical trials related to Pelvic Organ Prolapse.

Filter by:

NCT ID: NCT03052816 Completed - Pain, Postoperative Clinical Trials

Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery

ICET
Start date: April 1, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.

NCT ID: NCT03049020 Recruiting - Clinical trials for Pelvic Organ Prolapse Recurrence

The Efficacy of Laparoscopic Sacrocolpopexy in the Treatment of Pelvic Organ Prolapse in Women With or Without Avulsion of the Levator Ani Muscle

Start date: October 2014
Phase: N/A
Study type: Observational

Based on a prospective study, to evaluate how pre-operative pelvic floor status - the presence of injury to the musculus levator ani - may influence the results of laparoscopic sacrocolpopexy. The investigators hope to confirm or disprove the hypothesis that the presence of such injury increases the risk of post-operative prolapse recurrence

NCT ID: NCT03048682 Recruiting - Surgery Clinical Trials

Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Start date: January 5, 2017
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.

NCT ID: NCT03040011 Completed - Surgery Clinical Trials

Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

Start date: June 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total of 75 women will be performed. The study population will be adult women (>18 years of age) with uterovaginal or vaginal vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which includes an apical support procedure. Participants will be enrolled prior to surgery. The procedure will involved four injection sites: the bilateral levator ani muscles via a transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random assignment will occur to one of three study arms: combined arm (20 milliliters bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20 milliliters saline divided between the 4 injection sites).

NCT ID: NCT03034499 Completed - Clinical trials for Pelvic Organ Prolapse

Single Versus Multi-port Robotic Assisted Sacrocolpopexy for Repair of Vaginal Apex Prolapse

Start date: March 20, 2017
Phase: N/A
Study type: Interventional

A prospective randomized controlled study intended to compare the efficacy of 2 methods of robotic assisted sacrocolpopexy for the repair of vaginal apex prolapse: 1. Via single-port. 2. Via multi-port.

NCT ID: NCT03032848 Completed - Clinical trials for Pelvic Organ Prolapse

Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Start date: November 26, 2013
Phase: Phase 4
Study type: Interventional

To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.

NCT ID: NCT03009968 Completed - Clinical trials for Urinary Incontinence

Reducing Postoperative Catheterization

Start date: March 17, 2017
Phase: N/A
Study type: Interventional

After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute retention experience urinary tract infections in the postoperative period (6, 7). Many women consider being discharged with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery(8). At this time there is no consensus within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best assess voiding function postoperatively. FPMRS providers both within the United States and around the world utilize a variety of void trial methods and varying criteria to determine adequacy of post-operative voiding efficiency (5). The traditional backfill assisted void trial method involves the assessment of a postvoid residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently, there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations (9, 10). Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding. However, to date, no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating a more efficient void trial method, the investigators hope improve patients' postoperative experience and reduce catheterization and risk of urinary tract infection (UTI). This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population. This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad.

NCT ID: NCT03005977 Completed - Clinical trials for Pelvic Organ Prolapse

Identifying Stress Urinary Incontinence in Women With Pelvic Organ Prolapse

Start date: February 15, 2017
Phase: N/A
Study type: Interventional

What test is most sensitive in identifying stress urinary incontinence in women with pelvic organ prolapse; urodynamics, cough stress test, or pyridium pad test? The hypothesis states that there is a difference between the sensitivity of UDS, pyridium pad test and cough stress tests, with UDS being the most sensitive and the gold standard in identifying SUI in patients with pelvic organ prolapse.

NCT ID: NCT03005613 Recruiting - Urogenital Prolapse Clinical Trials

Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation

Start date: January 2017
Phase: N/A
Study type: Interventional

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

NCT ID: NCT02999724 Recruiting - Clinical trials for Pelvic Organ Prolapse

Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")

GROUP
Start date: January 2017
Phase: Phase 3
Study type: Interventional

Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that this medication can help reduce pain after surgery, including hysterectomy, where the uterus or "womb" is removed. Opioids are the first choice for pain medication administered after surgery, but carry significant side effects. Several studies have demonstrated that if patients are given gabapentin before surgery, they require less opioids after surgery. However, there have not been any studies examining gabapentin's effects on post-operative pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence. Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore patients experience a "bulge" or "pressure" in the vagina. Patients with these conditions are typically offered medical treatments, but some may require surgery, and this usually consists of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to patients undergoing urogynecologic surgery on their pain levels after surgery, including the amount of opioid pain medication required. We hypothesize that the patients who receive gabapentin before surgery will require significantly less opioids. Over a six-month period, patients seen in Urogynecology clinics will be invited to participate in the study. Women who are already on gabapentin for other reasons, have an allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand spoken English will be excluded from the study. After providing informed consent, they will be randomized to either receive gabapentin or a placebo pill. They will receive the standard surgical care, including the usual anesthesia for surgery and routine pain medications available after surgery. We will then compare the differences in opioid consumption in the first 24 hours after surgery as well as the time from the end of surgery to leaving to the recovery room and the length of recovery room stay between the gabapentin and placebo groups. We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the patients in each group.