Lower Urinary Tract Symptoms Clinical Trial
Official title:
Comparison of the Tunneling or Non-tunneling During Minimally Invasive Sacrocolpopexy in Terms of Lower Urinary Tract and Bowel Symptoms.
NCT number | NCT02856217 |
Other study ID # | 16-0157 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | September 25, 2018 |
Verified date | October 2019 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the
vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced pelvic
organ prolapse and serves as the criterion standard against which other operations are
compared. Abdominal sacrocolpopexy involves attaching the vaginal apex to the sacral anterior
longitudinal ligament reinforced with a graft, usually synthetic mesh. More than 225.000
surgeries are performed annually in the United States for pelvic organ prolapse. Abdominal
sacrocolpopexy is considered the most durable pelvic organ prolapse surgery, but little is
known about safety and long-term effectiveness.
Purpose of this study is to compare effect of tunneling or non-tunneling mesh placement on
lower urinary tract symptoms and bowel symptoms in patients who underwent surgery with
laparoscopic or robot-assisted sacrocolpopexy which is accepted surgical procedures for
pelvic organ prolapse.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 25, 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject is female - Subject is at least 18 years of age - Subject is who can English speaking and reading - Subject must have documented diagnosis of apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as Pelvic Organ Prolapse Quantification System (POP-Q) scores of C = -1/2 total vaginal length (TVL) - Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20), question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit") - Subject or subject's legally authorized representative is willing to provide written informed consent - Subject is willing and able to comply with the follow-up regimen Exclusion Criteria: - Subject is pregnant or intends to become pregnant during the study - Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis - Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical) - Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area - Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months) - Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan's syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica) - Subject has uncontrolled diabetes mellitus (DM) - Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit) - Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis) - Subject is currently participating in or plans to participate in another device or drug study during this study - Subject has a known sensitivity to polypropylene - Subject has had previous prolapse repair with mesh (abdominal or vaginal) - Subject is planning to undergo a concomitant vaginal repair with use of mesh |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol. 1996 Dec;175(6):1418-21; discussion 1421 — View Citation
Gadonneix P, Ercoli A, Salet-Lizée D, Cotelle O, Bolner B, Van Den Akker M, Villet R. Laparoscopic sacrocolpopexy with two separate meshes along the anterior and posterior vaginal walls for multicompartment pelvic organ prolapse. J Am Assoc Gynecol Laparo — View Citation
Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009 May;55(5):1089-103. doi: 10.1016/j.eururo.2009.01.048. Epub 2009 Feb 4. Review. — View Citation
Karram M, Goldwasser S, Kleeman S, Steele A, Vassallo B, Walsh P. High uterosacral vaginal vault suspension with fascial reconstruction for vaginal repair of enterocele and vaginal vault prolapse. Am J Obstet Gynecol. 2001 Dec;185(6):1339-42; discussion 1 — View Citation
Lee RK, Mottrie A, Payne CK, Waltregny D. A review of the current status of laparoscopic and robot-assisted sacrocolpopexy for pelvic organ prolapse. Eur Urol. 2014 Jun;65(6):1128-37. doi: 10.1016/j.eururo.2013.12.064. Epub 2014 Jan 8. Review. — View Citation
Luber KM, Boero S, Choe JY. The demographics of pelvic floor disorders: current observations and future projections. Am J Obstet Gynecol. 2001 Jun;184(7):1496-501; discussion 1501-3. — View Citation
Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD004014. doi: 10.1002/14651858.CD004014.pub4. Review. Update in: Cochrane Database Syst Rev. — View Citation
Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. Review. — View Citation
Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. — View Citation
Rosenblum N. Robotic approaches to prolapse surgery. Curr Opin Urol. 2012 Jul;22(4):292-6. doi: 10.1097/MOU.0b013e328354809c. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower Urinary Tract Symptoms | In follow-up, using questionnaires specifically, Pelvic Floor Distress Inventory Questionnaire - Short Form 20 will be used in preoperatively, in 2.week visit, 6.week visit and 12.months visit. | Up to 1 year | |
Secondary | Pelvic Organ Prolapse | In follow-up, using questionnaires specifically, Pelvic Floor Distress Inventory Questionnaire - Short Form 20 will be used in preoperatively, in 2.week visit, 6.week visit and 12.months visit. | Up to 1 year | |
Secondary | Lower Gastrointestinal Tract Symptoms | In follow-up, using questionnaires specifically, Pelvic Floor Distress Inventory Questionnaire - Short Form 20 will be used in preoperatively, in 2.week visit, 6.week visit and 12.months visit. | Up to 1 year | |
Secondary | Surgical duration (time from skin incision to skin closure) | Outcome will be collected from patients operation files | Postoperative 1.day | |
Secondary | Blood loss | Outcome will be collected from patients operation files and anesthesiology notes | Postoperative 1.day | |
Secondary | Intraoperative complications (conversion to open procedure or inadvertent structural lesions such as bladder, bowel, vessels, or solid organs) | Outcome will be collected from patients operation files and prospectively will be noted from surgeon who is the PI of the study. | Postoperative 1.day | |
Secondary | Postoperative complications (Clavien-Dindo classification) | The Clavien-Dindo Classification of Surgical Complications questionnaires will be used to collect the complications | Postoperative 7.day | |
Secondary | Sexual function | Evaluation of patient's sexual function with Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | Up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT03623880 -
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
|
N/A | |
Enrolling by invitation |
NCT06317116 -
Examining the Relationship Between Core Muscles and Bladder Issues in Children
|
||
Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
Recruiting |
NCT05814614 -
Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation
|
N/A | |
Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
Not yet recruiting |
NCT06452927 -
EEP in Patients With Urodynamically Proven DU/DA
|
N/A | |
Completed |
NCT03339609 -
Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children
|
N/A | |
Completed |
NCT02330107 -
Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men
|
N/A | |
Terminated |
NCT02003742 -
Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
|
Phase 3 | |
Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 | |
Completed |
NCT01078545 -
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
|
N/A | |
Completed |
NCT02074644 -
Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia
|
N/A | |
Recruiting |
NCT03802851 -
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
Recruiting |
NCT05702294 -
Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .
|
N/A | |
Enrolling by invitation |
NCT05537272 -
The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy
|
Phase 4 | |
Recruiting |
NCT05826691 -
Benign Prostate Surgery and QOL and Sexual Function
|
||
Completed |
NCT04104100 -
Prevalence and Risk Factor of NP in Women With LUTS
|
||
Completed |
NCT04190641 -
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder
|
N/A |