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Prolapse clinical trials

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NCT ID: NCT04491617 Completed - Postoperative Pain Clinical Trials

STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial

STOP-PAIN
Start date: August 27, 2020
Phase: N/A
Study type: Interventional

Overprescribing opioids is considered a major contributor to the opioid crisis. Hill et al. demonstrated that within a general surgery practice, over 70% of the prescribed opioid pills were never taken. Disturbingly, 45% of patients who did not take opioids at all on their day of discharge were discharged with an opioid prescription (Chen et al). Recent initiatives have attempted to utilize restrictive opioid prescribing protocols for postoperative pain management in which patients were prescribed a limited number of opioid tablets (Hallway et al) or prescribed opioids only if they were used as an inpatient (Mark et al). These well-conducted studies show that restrictive opioid prescribing policies achieve the goal of reducing excess opioid exposure without causing undue harm, inconvenience or dissatisfaction among patients. The objective of this study is to determine if a restrictive opioid prescription protocol (in which patients are not prescribed postoperative opioids unless they request them) is acceptable to patients after ambulatory and major urogynecologic surgery, compared to standard opioid prescribing practices. The study investigators believe that physicians can capitalize on the new ability to electronically prescribe opioids for patients who require them, to prevent over-prescribing without impacting patient care. The study also intends to describe postoperative opioid use patterns in the urogynecologic population, including factors predictive of opioid use and non-use. The results of this research will have a significant and timely impact by helping to reduce opioid overprescribing and informing future prescribing guidelines in the field of urogynecology.

NCT ID: NCT04417413 Completed - Clinical trials for Pelvic Organ Prolapse

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.

Start date: October 1, 2019
Phase:
Study type: Observational

The objective of the study is to retrospectively collect the data on patients who underwent pelvic organ prolapse treatment using a non-ablative Er:YAG laser with SMOOTH mode and to conduct an objective evaluation of safety and efficacy of Er:YAG laser treatment. In a group of patients that have concomitant stress urinary incontinence symptoms, the effectiveness of the treatments on these symptoms will be evaluated as well.

NCT ID: NCT04415710 Completed - Clinical trials for Urinary Incontinence

Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome

Start date: February 21, 2019
Phase:
Study type: Observational [Patient Registry]

Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.

NCT ID: NCT04369404 Completed - Overactive Bladder Clinical Trials

Impact of Decision Aids in Urogynecology

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.

NCT ID: NCT04332315 Completed - Clinical trials for Pelvic Organ Prolapse

Vaginally Assisted Laparoscopic Sacropolpopexy

VALS
Start date: July 1, 2015
Phase: N/A
Study type: Interventional

Introduction and Hypothesis: Vaginally assisted laparoscopic sacrocolpopexy (VALS), which is a combined surgical approach where a vaginal hysterectomy is initially performed, followed by transvaginal placement of synthetic mesh and laparoscopic suspension, can be an alternative to overcome the dissection, suturing limitations of laparoscopic sacrocolpopexy. The aim of this study was to compare the middle term anatomic outcomes, complication rates, and operative times of patients with uterovaginal prolapse undergoing VALS with those of women undergoing abdominal sacrocolpopexy. Methods: This is a prospective cohort study that evaluates operation times, anesthesia times, estimated blood loss, middle term outcomes, perioperative and postoperative complications. We compared the results of 47 women who had the VALS to that of 32 abdominal sacrocolpopexy.

NCT ID: NCT04329715 Completed - Clinical trials for Pelvic Organ Prolapse

Expedited Versus Restrictive: Limitations on Activity Following Surgical Treatment of Prolapse

EVeRLAST
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The objective of the EVeRLAST study is to determine whether expedited resumption of postoperative activity levels is non-inferior to standard activity restrictions with respect to short-term anatomic prolapse outcomes. We hypothesize that immediate resumption of physical activities as tolerated will result in noninferior surgical outcomes following prolapse surgery when compared to standard postoperative activity restrictions. Participants will be enrolled and randomized at their preoperative clinic visit to one of two treatment arms: Arm 1: Standard instructions (no heavy lifting over 10lbs for 6 weeks; return to work at 4 weeks for sedentary work and 6 weeks for manual labor) Arm 2: Liberal instructions (no restrictions; resume activities and work as soon as able) We will also collect subjective and objective measures of pre- and postoperative physical activity, through the use of patient-reported physical activity assessments and wrist-worn accelerometers. Accelerometer data will be collected at the preoperative, 2-week-postoperative, and 6-week-postoperative time points. Accelerometer data will also be used to calculate time to resumption of normal activities, defined as time at which a patient resumes greater than 90% of her baseline preoperative level of physical activity. We will additionally be collecting data on relevant patient-reported outcomes of pelvic floor symptom severity, health-related quality of life measures, postoperative pain, time to return to work (where relevant), and patient global impression of improvement. Postoperative anatomic assessments will be performed at 6 weeks and 3 months postoperatively by blinded study personnel

NCT ID: NCT04326699 Completed - Clinical trials for Lumbar Disc Herniation

Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

Start date: March 15, 2020
Phase: N/A
Study type: Interventional

Bilateral sacroiliac joint injection in symptomatic lumbar disc prolapse under ultrasound guidance and studying the effect of this technique on pain, spine mobility and activity of daily living.

NCT ID: NCT04291625 Completed - Ptosis, Eyelid Clinical Trials

Evaluation of Intraoperative Lagophthalmos Formula

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. included 20 eyelids from 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula

NCT ID: NCT04275089 Completed - Clinical trials for Pelvic Organ Prolapse

Early Feasibility Study of the Reia Vaginal Pessary

Start date: November 5, 2020
Phase: N/A
Study type: Interventional

This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse (POP). Recruited patients will have Stage II POP or greater and will be current users of a legally marketed vaginal pessary. In a single visit, data will be collected on the performance and comfort of the subject's current pessary. After placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. The study pessary's function will be assessed under controlled circumstances. The patient will have her current pessary replaced at the conclusion of the visit. Results will be used to inform future design modifications of the study pessary.

NCT ID: NCT04274491 Completed - Surgery Clinical Trials

Predictors of Recovery Expectancy

Start date: March 1, 2020
Phase:
Study type: Observational

The purpose of this study is to identify factors that influence a person's expectations regarding recovery from pelvic organ prolapse surgery. This is important because a person's expectations regarding recovery from surgery help to predict how a person will actually recover. Our hypothesis is that women with multiple roles will have expectations of a longer surgical recovery time after surgery for pelvic organ prolapse after controlling for known predictors of recovery expectancies. Participants will complete a preoperative online survey. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery.