Clinical trials: Pelvic Floor
Fecal Incontinence
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence
- Trial name
- TOPAS (NCT00565136)
- Testing
- TOPAS
- Where
- 5 sites in United States
- Volunteers
- 29 people
- Sponsor
- ASTORA Women's Health
Female Stress Urinary Incontinence
Treatment of Stress Urinary Incontinence Via Smartphone
The purpose of this study is to determine whether treatment of stress urinary incontinence (SUI) via smartphone is effective.
- Trial name
- NCT01848938
- Testing
- Smartphone treatment with PFMT
- Where
- Sweden
- Volunteers
- 123 people
- Sponsor
- Umeå University
Constipation Aggravated, Pelvic Floor; Incompetency
Proof of Concept: "Bottom's Up" Seat to Treat Constipation
Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory constipation due to pelvic floor laxity and excessive perineal descent by means of a modified toilet seat, known as "the Bottom's Up".
- Trial name
- NCT02419924
- Testing
- "the Bottom's Up"
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Pelvic Pain
Intra-vaginal Electrical Stimulation Device Compared to Sham Device for Chronic Pelvic Pain
The goal of the study is to evaluate the use of a personal intravaginal, non- implanted electrical stimulation device in the treatment of chronic pelvic pain.
- Trial name
- NCT02397785
- Testing
- ApexM
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- The Cleveland Clinic
Pelvic Floor Disorders
Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics
The purpose of this study is to determine a difference in patient reported pain levels before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel or water based lubricant.
- Trial name
- NCT01612156
- Testing
- 2% lidocaine gel, Water based lubricant
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University of Southern California
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
Parkinsons Disease
A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)
The purpose of this study is to see if the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in people with Parkinson's Disease.
- Trial name
- Maestro (NCT02092181)
- Testing
- Mirabegron
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Daniel Burdick, MD
Satisfaction, Postoperative Complications
Visits Versus Telephone Calls for Postoperative Care
The OPTIONs study is a randomized controlled, non-inferiority study to evaluate postoperative care using outpatient clinic visits versus telephone calls for women undergoing surgery for pelvic floor disorders.
- Conditions
- Satisfaction, Postoperative Complications, Pelvic Floor Disorder
- Trial name
- OPTIONs (NCT02891187)
- Testing
- Telephone follow-up, Outpatient Clinic Visits
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of New Mexico
Stress Urinary Incontinence
Pippa Pessary Study (Clinical Trial)
This is an open label, interventional, single arm, multi-clinic study where each adult female participant with stress urinary incontinence (SUI) serves as her own control (vaginal pessary use vs. no vaginal pessary).
- Trial name
- NCT05611970
- Testing
- Vaginal pessary
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Liv Labs Inc.
Endometriosis, Pelvic Pain
Endometriosis Group Care
The goal of this clinical trial is to test the effectiveness of the Peer Empowered Endometriosis Pain Support (PEEPS) program in people living with endometriosis-related pelvic pain.
- Trial name
- PEEPS (NCT05622955)
- Testing
- Peer Empowered Endometriosis Pain Support (PEEPS)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Washington University School of Medicine
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 Incontinence, Stress, Urinary Incontinence, Urge
Combined Treatment for Mixed Incontinence
The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms…
- Trial name
- ESTEEM (NCT01959347)
- Testing
- Miduretheral Sling, Miduretheral Sling with behavioral/pelvic floor therapy
- Where
- 10 sites in United States
- Volunteers
- 480 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Pelvic Floor Disorders, Pelvic Pain
Vaginal Diazepam for the Treatment of Female Pelvic Pain
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.
- Trial name
- NCT01938092
- Testing
- Diazepam
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Raymond Foster
Rectal Cancer
Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer
Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of positive margins and improves oncological outcome…
- Trial name
- BIOPEX (NCT01927497)
- Testing
- Biological mesh assisted perineal closure, Primary perineal closure
- Where
- Netherlands
- Volunteers
- 104 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Pelvic Floor Disorders
Platelet Rich Plasma in Levator Ani Muscle Trauma
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
- Trial name
- NCT03021954
- Testing
- Platelet Rich Plasma
- Where
- Indonesia
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
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
Prostate Cancer
Prostate Cancer - Patient Empowerment Program
Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option.
- Trial name
- PC-PEP (NCT03660085)
- Testing
- PC-PEP
- Where
- Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Nova Scotia Health Authority
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 Disorders, Stress Urinary Incontinence
The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM…
- Trial name
- SUI (NCT03194789)
- Testing
- Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy, Traditional Pelvic Floor Therapy
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Montefiore Medical Center
Constipation
Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation
Constipation is a common problem in the general population. Defecation disorders caused by abnormal contraction or insufficient relaxation of the pelvic floor muscles during defecation may be one of the most possible causes of…
- Trial name
- NCT04661202
- Testing
- multimodal exercise training
- Where
- Taiwan
- Volunteers
- 27 people
- Sponsor
- National Cheng Kung University