Clinical trials: Pelvic Floor Prolapse
Pelvic Organ Prolapse
Pelvic Floor Repair Systems for Prolapse Repair
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for…
- Trial name
- PROPEL (NCT00638235)
- Testing
- AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP, AMS Perigee™ with IntePro
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 725 people
- Sponsor
- ASTORA Women's Health
Urinary Tract Infections
Nitrofurantoin and Urinary Tract Infections (UTIs)
Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections.
- Trial name
- APPIC (NCT00678041)
- Testing
- Nitrofurantoin
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Pelvic Organ Prolapse
Smartmesh Technology in Pelvic Floor Repair Procedures
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical.
- Trial name
- Restorelle (NCT03098641)
- Testing
- pelvic organ prolapse repair
- Where
- 16 sites in France
- Volunteers
- 272 people
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
Urethra Issue, Pelvic Organ Prolapse
Lessons on Urethral Lidocaine in Urodynamics
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum…
- Conditions
- Urethra Issue, Pelvic Organ Prolapse, Urinary Incontinence, Vaginal Vault Prolapse
- Trial name
- LULU (NCT04038099)
- Testing
- Water-Based Vaginal Lubricant, lidocaine topical
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Texas Southwestern Medical Center
Pelvic Floor Disorders, Stress Urinary Incontinence
Educating Women About Pelvic Floor Disorders During Pregnancy
The purpose of this study is to assess the increase in knowledge of pregnant patients regarding pelvic floor disorders when comparing two educational interventions: written handouts vs interactive workshops.
- Conditions
- Pelvic Floor Disorders, Stress Urinary Incontinence, Pelvic Organ Prolapse
- Trial name
- NCT05440539
- Testing
- Written Handouts, Interactive Workshop
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Pelvic Organ Prolapse, Menopause
Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall.
- Trial name
- PET (NCT01778985)
- Testing
- Premarin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Pelvic Organ Prolapse, Urinary Incontinence
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders, Gynecologic Disease
- Trial name
- CLNUP (NCT04048356)
- Testing
- Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
Pelvic Organ Prolapse, Urinary Incontinence,Stress
Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial…
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence,Stress, Surgery
- Trial name
- NCT03048682
- Testing
- Foley catheter - Early Voiding Trial, Foley catheter - Late Voiding Trial
- Where
- 2 sites in United States
- Volunteers
- 64 people
- Sponsor
- The Cleveland Clinic
Pelvic Organ Prolapse
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment…
- Trial name
- NCT01648751
- Testing
- Vaginal estrogen
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Pamela Moalli
Pelvic Floor Disorders
Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help…
- Trial name
- NCT01886794
- Testing
- Postmenopausal, topical vaginal estrogen cream
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Pelvic Organ Prolapse, Urogenital Prolapse
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared…
- Conditions
- Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele
- Trial name
- IMPROVE (NCT02431897)
- Testing
- Conjugated Estrogens Cream
- Where
- 3 sites in United States
- Volunteers
- 206 people
- Sponsor
- University of Texas Southwestern Medical Center
Pelvic Organ Prolapse (POP)
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.
- Trial name
- (A&P) (NCT01378065)
- Testing
- Restorelle Direct Fix A&P
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Pelvic Floor Disorders
Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse
Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been studied in our department over the last 6 years.
- Trial name
- NCT02774798
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- Manchester University NHS Foundation Trust
Obstetric; Injury Pelvic Floor
The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic…
- Trial name
- NCT01045135
- Where
- Norway
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University Hospital, Akershus
Nerve Block, Pain, Postoperative
Pudendal Nerve Block in Vaginal Surgery
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared…
- Conditions
- Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse
- Trial name
- NCT04198714
- Testing
- Pudendal block
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- MetroHealth Medical Center
Pelvic Floor Dysfunction
Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry
Anal Acoustic Reflectometry (AAR) is a reliable and reproducible technique that has been studied in our department over the last 6 years.
- Trial name
- NCT02782377
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Manchester University NHS Foundation Trust
Pelvic Organ Prolapse
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
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.
- Trial name
- NCT01541748
- Testing
- Axis
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Vaginal Vault Prolapse, Pelvic Organ Prolapse
Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse.
- Conditions
- Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Prolapse
- Trial name
- NCT02680145
- Testing
- Preoperative Pessary Use
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Mayo Clinic