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Prolapse clinical trials

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NCT ID: NCT01560377 Completed - Rectal Cancer Clinical Trials

Perfusion Assessment in Laparoscopic Left Anterior Resection

PILLAR II
Start date: May 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.

NCT ID: NCT01559168 Completed - Clinical trials for Pelvic Organ Prolapse

Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

Start date: October 2012
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.

NCT ID: NCT01551992 Completed - Prolapse Clinical Trials

Affixing Polypropylene Mesh Using Barbed Suture (Quill™ Srs) During Laparoscopic Sacrocolpopexy Randomized Controlled Trial (Quill Lsc)

QUILL-LSC
Start date: November 2010
Phase: N/A
Study type: Interventional

1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 1.2 SECONDARY OBJECTIVE - To compare laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates. 2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 2.2.b. Failure rates and mesh erosion rates for each technique will be equally low. 2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.

NCT ID: NCT01548989 Completed - Clinical trials for Urinary Incontinence

Validation of a New Sexuality Questionnaire for Patients With Urinary Incontinence or Pelvic Organ Prolapse

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

The main objective of this study is to perform the linguistic validation of a new french questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

NCT ID: NCT01548976 Completed - Clinical trials for Urinary Incontinence

Validation of a French Version of the PISQ-R

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

The main objective of this study is to perform the linguistic validation of the french version of the PISQ-R questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

NCT ID: NCT01548105 Completed - Clinical trials for Pelvic Organ Prolapse

Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse

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

Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found to be associated with severe POP. The authors' proposed explanation was that smoking impairs tissue and wound healing. Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.

NCT ID: NCT01541748 Completed - Clinical trials for Pelvic Organ Prolapse

Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study

Start date: November 2011
Phase:
Study type: Observational

This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.

NCT ID: NCT01540214 Recruiting - Clinical trials for Pelvic Organ Prolapse

Study of Overactive Bladder in Women With Prolapse

SOAP
Start date: February 2012
Phase: N/A
Study type: Observational

Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are present in approximately 50% of patients with POP. For many women the accompanying symptoms of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with dissatisfaction with the final results of an operation for POP. The primary aim of this research project is to investigate the difference in prevalence (i.e. improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair surgery. The secondary objectives are to determine changes in bladder function at 6 and 12 months after surgery and to identify predictive factors for persistence, disappearance or de novo symptoms of OAB after POP surgery. Women who present with POP and who will undergo surgical treatment will be evaluated at baseline before their surgery and will be followed for the duration of one year after surgery.

NCT ID: NCT01535833 Recruiting - Clinical trials for Pelvic Organ Prolapse

Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves

Start date: February 2012
Phase: N/A
Study type: Interventional

The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period.

NCT ID: NCT01530191 Withdrawn - Clinical trials for Pelvic Organ Prolapse

Factors Affecting Perioperative Outcomes

Start date: September 2011
Phase: N/A
Study type: Observational

The specific aim of this study is to determine if pre-existing depression and anxiety affect perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse. - Hypothesis 1: Patients with depression will have increased analgesic use and longer hospital stays postoperatively - Hypothesis 2: Patients with anxiety will have increased analgesic use and longer hospital stays postoperatively. A secondary aim is to characterize the incidence and severity of depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse.