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Uterine Prolapse 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: NCT06234449 Not yet recruiting - Clinical trials for Pelvic Organ Prolapse

The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery

Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

Patients aged 45 to 80 years with a clinical diagnosis of stage III and IV genital prolapse involving the anterior and/or middle compartments and candidates for surgery will be considered. These will be evaluated to observe whether there is improvement in clinical prolapse with the use of the vaginal pessary during the waiting period for surgery

NCT ID: NCT04251923 Not yet recruiting - Quality of Life Clinical Trials

Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence

Start date: January 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Prevalence of pelvic organ prolapsed is high in Nepal. After prolapse surgery many patients are affected with incontinence. Incontinence has physical, social and mental effect to the individual. This study is designed to know the role for mid urethral sling during vaginal prolapse surgery to decrease the rate of incontinence after the surgery.

NCT ID: NCT04078802 Not yet recruiting - Vaginal Prolapse Clinical Trials

0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse

Start date: October 2019
Phase: N/A
Study type: Interventional

VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.

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.

NCT ID: NCT03333811 Not yet recruiting - Vaginal Prolapse Clinical Trials

Sexual Function After Vaginal Repair With Perineorrhaphy

Start date: February 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if perineorrhaphy performed with surgical vaginal prolapse repair improves sexual function.

NCT ID: NCT03056586 Not yet recruiting - Cystocele Clinical Trials

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

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

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.