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Pelvic Organ Prolapse clinical trials

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NCT ID: NCT02578056 Enrolling by invitation - Clinical trials for Pelvic Organ Prolapse

Advanced Genital Prolapse Surgery With and Without Mid Urethral Sling to Prevent Stress Urinary Incontinence

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

Pelvic organ prolapse (POP) is a public health problem worldwide, affecting about 30 %. It implies physical, psychological and social losses. A frequent complication after surgeries for POP is developing de novo stress urinary incontinence (SUI). SUI and POP have similar pathophysiology and therefore it is common to coexist in the same patient. De novo SUI has a prevalence 11-44 % after surgical correction of genital prolapse. Occult urinary incontinence (OUI) is considered the major risk factor for postoperative SUI. Studies on this topic show conflicting results. In a recent meta-analysis on this subject, Maher et al concluded that the value of performing any anti- incontinence procedure in continent women undergoing prolapse surgery remains unknown. The aims of this study are to evaluate whether the association of a transvaginal tape (TVT®) in continent patients undergoing surgery for prolapse decreases the risk of de novo SUI and if it implies an improvement in their quality of life. The secondary endpoints are to assess the complications associated with this procedure, as irritative symptoms and voiding dysfunction postoperatively and assessing the ability of stress testing with reduced POP and urodynamics in predicting the risk of de novo SUI. This study will be a prospective, multicentric, randomized experimental study. Patients with anterior or apical prolapse stages 3 and 4 (POP - Q) will be invited to participate in the study. The study will assess these patients for staging of prolapse, the presence of occult urinary incontinence and quality of life. Selected patients will be randomized to perform correction of genital prolapse and prophylactic anti-incontinence procedure or correction of genital prolapse only. Patients will be assessed 3, 6 and 12 months after surgery. Postoperative evaluation will be similar to preoperative. The exclusion criteria are: complaint or diagnosis of stress urinary incontinence before reduction of the prolapse, previous surgery for incontinence or pelvic organ prolapse, hypocontractility detrusor in urodynamics and inability to understand and give informed consent.

NCT ID: NCT02548858 Completed - Clinical trials for Pelvic Organ Prolapse

Perineorrhaphy Outcomes Related to Body Imagery

POETRY
Start date: August 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether performing a perineorrhaphy during a reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body image.

NCT ID: NCT02536001 Not yet recruiting - Clinical trials for Pelvic Organ Prolapse

Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to compare anatomical differences, quality of life and sexual function and complications rate between apical support with one anterior vaginal mesh versus repair with two separate meshes.

NCT ID: NCT02502838 Completed - Overactive Bladder Clinical Trials

The Effect of an Additional Stress Incontinence Procedure on Overactive Bladder During Pelvic Organ Prolapse Repair

Start date: May 2015
Phase: N/A
Study type: Observational

Pelvic organ prolapse (POP) is a common condition in women. Approximately 20% of women undergo surgical correction for POP in their lifetime. Overactive bladder symptoms (OAB) are often associated with POP in 25-69% of patients and POP has been shown to be an independent risk factor for OAB. There is scientific evidence that surgical repair of POP reduces or eliminates OAB in >85%. In addition, stress urinary incontinence (SUI) is also often associated with POP, either clinically evident or as a potential post-operative complication. The clinical decision as to include a surgical technique to treat SUI when repairing POP surgically is still a matter of controversy. Most surgeons at the institution will include an extra procedure, specifically a retropubic sling, if SUI is clinically evident. Some will not include it unless there is urodynamic or clinical evidence of potential SUI post-operatively. Finally, some will include it regardless of clinical or urodynamic findings based on the apparent high incidence of such SUI after prolapse repair. The Tension-Free-Vaginal Tape (TVT) has been observed to reduce OAB as well as produce de-novo OAB symptoms, so the effect of TVT on OAB is still unclear. The purpose of this study is to determine the effect of additional TVT surgery on OAB symptoms in patients undergoing POP repair. It is hoped that such data will better determine the effect of either surgical intervention strategy on OAB symptoms. This is a prospective cohort study comparing patients with OAB that undergo surgical repair of their prolapse with or without additional TVT surgery. The outcomes will be measured using pre- and post-operative validated questionnaires (PFDI-20, OAB-q short form).

NCT ID: NCT02502591 Completed - Clinical trials for Pelvic Organ Prolapse

Pudendal Nerve Block for Postoperative Posterior Repair Pain Relief

PPPR
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Rectocoele or a posterior vaginal prolapse (bulge in the vagina) is a frequent gynaecological condition. It is repaired by repairing and reinforcing the support to the vaginal wall at the back. A small cut is made through the lining of the back wall of the vagina. The supports to the rectum are reinforced with stitches and the bulging part of the vaginal wall cut away. The wound in the vagina is then stitched up. Rectocoele repair is usually carried under a general anaesthetic with women reporting moderate to severe degrees of pain post operatively on sitting down. A Pudendal Nerve Block (PNB) is a common analgesic (pain killing) technique often used for women who need an instrumental delivery during childbirth. It is also widely used during a range of surgical procedures (operations) as a preventive analgesia to help reducing post -operative pain. The investigators would like to see if using this technique during routine rectocele repair will help with post - op pain.

NCT ID: NCT02502357 Completed - Clinical trials for Pelvic Organ Prolapse

Healing Statements and Their Effect on Post Operative Pain

PHSPOPC
Start date: July 2015
Phase: N/A
Study type: Interventional

This is a randomized clinical trial comparing the severity of post-operative pain and use of pain medication in women who are and are not exposed to healing statements before undergoing vaginal hysterectomy with minimally invasive sacrocolpopexy. The investigators' hypothesis is that those who are read healing statements before surgery will require less post-operative pain medications and experience less severe pain than those who do not hear the statements.

NCT ID: NCT02479685 Completed - Clinical trials for Pelvic Organ Prolapse

SORD-BILL Vs Conventional Options During Sacral Colpopexy for POP

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

This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic morcellator.

NCT ID: NCT02465710 Recruiting - Clinical trials for Pelvic Organ Prolapse

Comparisons of Clinical Outcomes Between Novel Tailored Transvaginal Mesh Surgery and Vaginal Native Tissue Repair Surgery for Pelvic Organ Prolapse

Start date: April 2015
Phase: N/A
Study type: Observational

The issue of whether utilizing the mesh in the surgical treatment of pelvic organ prolapse remained undetermined.Thus, the aim of this study is to analyze clinical outcome of women who underwent pelvic organ prolapse surgeries with and without mesh implantation in the Department of Obstetrics & Gynecology of National Taiwan University Hospital.

NCT ID: NCT02465658 Recruiting - Clinical trials for Pelvic Organ Prolapse

Risk Factors for Co-existence of Cervical Elongation in Uterine Prolapse

Start date: March 2015
Phase: N/A
Study type: Observational

The presence of co-existence of cervical elongation in women of uterine prolapse may decrease the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.

NCT ID: NCT02449915 Completed - Clinical trials for Pelvic Organ Prolapse

Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse

Start date: March 2015
Phase: Phase 4
Study type: Interventional

To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.