Clinical Trials Logo

Pelvic Organ Prolapse clinical trials

View clinical trials related to Pelvic Organ Prolapse.

Filter by:

NCT ID: NCT02111642 Completed - Clinical trials for Pelvic Organ Prolapse

Effect of a Risk Calculator on Patient Satisfaction With the Decision for Midurethral Sling During Prolapse Surgery

Start date: June 2014
Phase: N/A
Study type: Interventional

Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is the only option which potentially offers a cure. It is well known that women with pelvic organ prolapse are at risk of developing new stress urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing, coughing, or laughing. Previous studies have demonstrated that the addition of a prophylactic anti-incontinence procedure at the time of prolapse surgery reduces this risk. One example of such a procedure is a mesh sling placed underneath the urethra (midurethral sling). Nevertheless, the decision to place a midurethral sling to prevent stress urinary incontinence after prolapse surgery remains controversial. A new risk calculator tool has been developed to provide patients' with their individualized risk of developing de novo stress urinary incontinence after prolapse surgery. The primary objective of this study is to determine whether use of this new personalized online risk calculator tool increases patient satisfaction with the decision whether or not to have a midurethral sling placed at the time of prolapse surgery to prevent development of stress urinary incontinence. The investigators hypothesize that use of this tool will increase patient satisfaction with their decision regarding midurethral sling placement.

NCT ID: NCT02073734 Completed - Clinical trials for Pelvic Organ Prolapse

Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP

Start date: February 2013
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.

NCT ID: NCT02049996 Completed - Clinical trials for Pelvic Organ Prolapse

Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?

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

The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair. We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.

NCT ID: NCT02021279 Completed - Clinical trials for Pelvic Organ Prolapse

ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study

Start date: June 11, 2014
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.

NCT ID: NCT01997996 Completed - Clinical trials for Pelvic Organ Prolapse

ProViS (Prolift+M and Vita Sexualis) Study

ProViS
Start date: May 2011
Phase: N/A
Study type: Observational

Transvaginal meshes (TVM) are indicated for the treatment of pelvic organ prolapse (POP) where surgical intervention is necessary. Due to a potential risk of de novo dyspareunia, TVM are mainly used in postmenopausal women and in case of recurrent POP. PROLIFT+M (Trademark) is based on a highly flexible material which is partially absorbable. We suggest that PROLIFT+M has less impact on the vita sexualis than conventional TVM and could also be used for the treatment of younger and/or sexually active women. This study observes women who are routinely treated with PROLIFT+M with regard to their sexual function before and after the surgery. The hypothesis is that there is no worsening in vita sexualis with PROLIFT+M.

NCT ID: NCT01967446 Completed - Clinical trials for Pelvic Organ Prolapse

Predictors of Post Operative Morbidity in Older Women With Pelvic Organ Prolapse

Start date: March 2012
Phase: N/A
Study type: Observational

The Investigators hypothesize that functional status scores in elderly women undergoing surgery for pelvic organ prolapse will be lower at 6 weeks post-operatively but will have returned to baseline at 12 weeks post-operatively. The Investigators hypothesize that greater co-morbidity, frailty and worse functional status before surgery are associated with slower functional recovery, prolonged length of stay in a hospital or nursing care institution and greater post-operative complications following surgery for pelvic organ prolapse.

NCT ID: NCT01945580 Completed - Clinical trials for Pelvic Organ Prolapse

Xenform Postmarket Surveillance Study

Xenform
Start date: February 10, 2014
Phase: N/A
Study type: Interventional

To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

NCT ID: NCT01917968 Completed - Clinical trials for Pelvic Organ Prolapse

Uphold LITE Post-Market Surveillance Study

Uphold LITE
Start date: October 10, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

NCT ID: NCT01864408 Completed - Clinical trials for Pelvic Organ Prolapse

Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider Counseling

iPad
Start date: May 2012
Phase: N/A
Study type: Interventional

The primary aim is to assess whether an interactive patient/provider counseling process using a web-based tool (iPadTM) will improve patient satisfaction regarding understanding of her bulge symptoms. The secondary aims are to assess whether an interactive patient/provider counseling process using web-based tool (iPadTM) will: 1. Decrease patient anxiety with counseling 2. Improve patient satisfaction with counseling 3. Improve provider knowledge, anxiety, and satisfaction with counseling 4. Be easy to use in clinic 5. Be actually used in clinic

NCT ID: NCT01852422 Completed - Clinical trials for Pelvic Organ Prolapse

Location and Anatomic Characterization of the Sacrospinous Ligaments in Women With Pelvic Organ Prolapse

Start date: June 2013
Phase:
Study type: Observational

Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse surgery, there is a paucity of information regarding the identification of these structures outside of surgical dissection. Furthermore, there is no published data describing the relative distances between the apex of the vagina and these ligaments in women with prolapse. Recent developments in imaging have enabled the identification of the distal subdivisions of the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the subdivisions of the pubovisceralis. The visualization of these structures is possible using a 3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and in live humans, with excellent interrater reliability. The investigators propose to use this technology to explore the anatomy of the sacrospinous ligaments.