Clinical trials: Pelvic Floor Disorder
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
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
Pudendal Nerve, Healthy Women
Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women
This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.
- Trial name
- ELANEP (NCT07458737)
- Testing
- Pelvic floor shear wave elastography, Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7), Female Sexual Distress Scale-Revised (FSDS-R)
- Where
- Slovakia
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Comenius University
Stress Urinary Incontinence, Pelvic Floor Disorders
Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence.
- Trial name
- NCT03520114
- Testing
- RP sling placement, SIS placement
- Where
- 6 sites in United States
- Volunteers
- 280 people
- Sponsor
- Wake Forest University Health Sciences
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
Cystitis, Interstitial
Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide
To implement and assess clinical efficacy of a text message and multimedia-based program that (i) remotely delivers first- and second-line American Urological Association (AUA) treatments of IC/BPS; (ii) integrates treatment of…
- Trial name
- ERICA (NCT05260112)
- Testing
- ERICA
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- University of Pennsylvania
Urinary Incontinence, Pelvic Floor Muscle Weakness
Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence
Urinary incontinence (UI) symptoms are highly prevalent among women, and menopause is one of the risk factors for UI. During the menopausal transition, not only the hormonal secretion is changed but also the level of physical…
- Trial name
- NCT04351750
- Testing
- general exercise, pelvic floor muscle training
- Where
- Taiwan
- Volunteers
- 47 people
- Sponsor
- National Cheng Kung University
Bladder Exstrophy
Navigation of the Pelvic Floor in Bladder Exstrophy Using Pre-operative MRI
The aim of this study is to investigate the use of intraoperative stereotactic imaging of the pelvic floor musculature during closure of bladder exstrophy.
- Trial name
- NCT01878500
- Testing
- Intraoperative stereotactic imaging with VectorVision
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Johns Hopkins University
Urinary Incontinence, Prostate Cancer
Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but pelvic floor muscle training and exercise (including urine control strategies) have been shown to reduce the time to regaining urine…
- Trial name
- ProsTel (NCT01960998)
- Testing
- Pelvic Floor Muscle Training, Perioperative Care and Wetness Management
- Where
- 3 sites in United States
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
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 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