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Prolapse, Vaginal clinical trials

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NCT ID: NCT06416982 Not yet recruiting - Pain Clinical Trials

Perineal Massage for Pessary Examinations

Start date: June 2024
Phase: N/A
Study type: Interventional

Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimization of resource utilization. More techniques to improve pessary examination comfort are needed. Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort, theoretically by desensitizing the nerve endings in the skin, broadening the vaginal opening, and increasing elasticity of the perineal tissue. Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus, perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks. The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial. Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study. The study will involve two clinical visits. At the first visit, the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times; versus application of gel to the internal vagina and external vagina without massage. Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols. Patients will rate self-reported pain before, during pessary check, and after the pessary check on a VAS scale; and rate whether they would prefer to repeat this method at future visits via Likert scale. Healthcare professionals will also rate perceived patient pain on VAS scale; ease of pessary removal; and note any perineal or introital laceration or abrasion that may occur during the pessary fitting. At the following visit, patients will be assigned to the group to which they were not initially randomized. Patients and healthcare professionals will again rate pain as described above. Patients will also rank preference for perineal massage using PGI-I.

NCT ID: NCT05750615 Recruiting - Prolapse; Female Clinical Trials

What Affects Willingness to Self-manage a Pessary?

Start date: August 25, 2022
Phase:
Study type: Observational

Pessary self-management is defined as the patient's ability to remove and reinsert their pessary themselves at home. Previous research has suggested that some women may prefer being able to remove and reinsert their pessary as they wish rather than wait for clinic appointments. At the moment, not enough is known about pessary self-management, particularly what makes someone more or less likely to try pessary self-management. The investigators would like to understand this better to try to help women overcome barriers they might face. This study aims to collect data via both questionnaires and interviews to explore willingness to self-manage a pessary. Using findings from the questionnaires and interviews, a group of women who use pessaries and healthcare professionals who provide pessary care will work together to develop a better way to support women to feel able and willing to manage their pessary in future.

NCT ID: NCT05633901 Recruiting - Prolapse; Female Clinical Trials

Impact of Preop Video on Patient Anxiety

Start date: December 7, 2022
Phase: N/A
Study type: Interventional

To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery

NCT ID: NCT04882995 Completed - Constipation Clinical Trials

Effect of Preoperative Fiber on Postoperative Bowel Function

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation. The investigators are conducting this study to determine if participants who receive psyllium fiber before surgery have less difficulty with their first bowel movement after surgery.

NCT ID: NCT04440475 Recruiting - Pain, Postoperative Clinical Trials

Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy

SACROTAP
Start date: June 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether the transversus abdominis plane block (Tap block) is different than the oral postoperative pain medications in controlling pain after robotic sacrocolpopexy.

NCT ID: NCT04172896 Recruiting - Clinical trials for Vaginal Vault Prolapse

Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse

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

Post-hysterectomy vaginal vault prolapse is a common pelvic floor disorder described as descent of the vaginal apex after hysterectomy. The incidence of post-hysterectomy vault prolapse has been reported to follow 11.6% of hysterectomies performed for prolapse and 1.8% for other benign diseases. The majority of surgical repairs to correct post-hysterectomy vault prolapse are approached via a transvaginal route. A common transvaginal procedure to correct vaginal vault prolapse is the uterosacral ligament suspension. Traditionally, the uterosacral ligaments have been accessed intraperitoneally to perform the vaginal suspension. More recently, an extraperitoneal approach has been utilized with good results. There is limited evidence comparing the the two approaches. Thus, the objectives of this study are to compare compare operative time, hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches.

NCT ID: NCT03966469 Completed - Surgery Clinical Trials

What is the Impact of the Presence of a Support Person on Informed Consent

Start date: May 17, 2019
Phase:
Study type: Observational

In practice, the Investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators are exploring if having a support person present during this consent process impacts anxiety, satisfaction, knowledge, and preparedness for surgery.

NCT ID: NCT03962075 Completed - Prolapse, Vaginal Clinical Trials

Short-term Outcomes of Laparoscopic Repair of Paravaginal Defects

Start date: August 1, 2016
Phase: N/A
Study type: Interventional

this study designed To evaluate the efficacy and outcomes of laparoscopic approach for repair of paravaginal defects associated with anterior vaginal wall prolapse.

NCT ID: NCT03875989 Recruiting - Prolapse, Vaginal Clinical Trials

Vaginal Native Tissues Repair for Pelvic Organ Prolapse

TAPP
Start date: September 27, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.

NCT ID: NCT03527082 Not yet recruiting - Prolapse, Vaginal Clinical Trials

Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery

Start date: July 2018
Phase:
Study type: Observational

This is a questionnaire study that is being performed to ascertain the knowledge and attitudes of women towards use of mesh in gynaecological surgery. Women over the age of 18, able to read and comprehend the information leaflet, sign and give informed consent will be eligible to participate. Women who are not fluent in English will be able to participate if a translator can convey the information. The trial will be conducted at Epsom and St Helier Hospitals, in the United Kingdom. The investigators aim to recruit 150 women to this study. No power calculation has been performed as this is an exploratory study. However, previous studies have included 64 and 77 women respectively.