Clinical trials: Pelvic Floor Disorders
Overactive Bladder
The Estrogen Impact on Overactive Bladder Syndrome: Female Pelvic Floor Microbiomes and Antimicrobial Peptides
The medical field is beginning to adopt treatments that alter an individual's microbiome to improve patient health; however, this approach has not been adopted for treatment of lower urinary tract symptoms (LUTS).
- Trial name
- NCT02524769
- Testing
- conjugated estrogen
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Loyola University
Pelvic Floor Disorders
Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial
The aim of the study is to determine if In-person interpreters increases patient satisfaction of URGYN office visits compared to the use of phone interpreter services for Limited English Proficient (LEP) patients
- Trial name
- SIPI (NCT03470194)
- Testing
- Interpretation Modality: In Person, Interpretation Modality: Telephonic
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- University of Massachusetts, Worcester
Patient Compliance, Pelvic Floor Disorders
Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
The investigators intend to measure compliance with attending pelvic floor physical therapy (PFPT) in a Urogynecology population by randomizing patients to either viewing a four minute educational video or reading a handout…
- Trial name
- NCT02875977
- Testing
- Educational video, Educational handout
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Elizabeth Mueller
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
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
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
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
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
Urinary Incontinence
Postpartum Pelvic Floor Muscle Training in Women With and Without Injured Pelvic Floor Muscles
Although pregnancy and childbirth are associated with happiness and a positive life change for most women, it can also be considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction.
- Trial name
- NCT01069484
- Testing
- Postpartum pelvic floor muscle training
- Where
- Norway
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Norwegian School of Sport Sciences
Urinary Incontinence,Stress, Urinary Incontinence, Urge
RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application
This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health…
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Urinary Incontinence, Overactive Bladder Syndrome
- Trial name
- DINKS (NCT06389838)
- Testing
- Kranus Mictera
- Where
- Germany
- Volunteers
- 194 people
- Sponsor
- Kranus Health GmbH
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
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
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
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
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 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 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
Endometriosis-related Pain, Endometriosis
Enriched Environments in Endometriosis
The investigators propose to conduct a randomized behavioral trial that will produce a clinically useful multi-level integrative medicine model to be used in stress- and inflammation-related disorders that can easily be…
- Conditions
- Endometriosis-related Pain, Endometriosis, Pelvic Pain, Quality of Life
- Trial name
- NCT04179149
- Testing
- Environmental enrichment
- Where
- Puerto Rico
- Volunteers
- 56 people
- Sponsor
- Ponce Medical School Foundation, Inc.
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