Pelvic Organ Prolapse

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23 Pelvic Organ Prolapse Trials Near You

Power is an online platform that helps thousands of Pelvic Organ Prolapse patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

420 Participants Needed

This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.
No Placebo Group

Trial Details

Trial Status:Recruiting
Sex:Female

160 Participants Needed

The study aims to determine if defecation posture, when using a defecation posture modification device (DPMD), will improve ease of bowel movements in patients with pelvic organ prolapse, specifically rectoceles.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

60 Participants Needed

The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

476 Participants Needed

The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years. A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Age:21+
Sex:Female

183 Participants Needed

The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21+
Sex:Female

360 Participants Needed

The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are: * Is the leading edge of the prolapse above the hymen * Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:21 - 89
Sex:Female

50 Participants Needed

This study is being done to evaluate the safety and feasibility of using flat polypropylene Restorelle® mesh, an ultra-lightweight mesh, for transvaginal use in surgically correcting certain specific cases of pelvic organ prolapse, such as recurrent (previous failed native tissue repair), large stage III or IV pelvic organ prolapse, and those with symptomatic uterine prolapse desiring uterine-sparing surgery (called hysteropexy).
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Sex:Female

30 Participants Needed

Surgery for Constipation

Skokie, Illinois
Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population. Laparoscopic abdominal ventral rectopexy is an established surgical technique aimed at restoring rectal support in women with this condition. It is the most common surgery used nowadays to treat ODS. Transvaginal sacrospinous rectopexy, is an innovative procedure which has been shown to be safe and effective in the treatment of stool entrapment. Currently it is unknown whether one of the procedures mentioned is superior to the other regarding surgical outcomes and patient experience. The purpose of this research is to compare the outcomes of these two procedures considering their efficacy to improve symptoms. During the study, participants will be randomized to undergo one of two procedures for treatment of inability to completely empty their bowel and/or rectal prolapse: 1) laparoscopic abdominal ventral rectopexy; 2) transvaginal sacrospinous rectopexy. Following the procedure, participants will be asked to return to the office for a follow-up visit 2-weeks, 2-, 12- and 24-months after the surgery. During each follow-up visit participants will undergo symptom evaluation, pelvic exam and transvaginal pelvic ultrasound to evaluate surgical success.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

120 Participants Needed

Reia Pessary for Prolapse

Northbrook, Illinois
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 182 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events. Specific Aims Aim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 3: To compare ease/difficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

182 Participants Needed

Barbed Sutures for Uterine Prolapse

Winston-Salem, North Carolina
Minimally invasive sacrocolpopexy (SCP) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. One of the time consuming parts of the procedure is vaginal mesh attachment.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 80
Sex:Female

52 Participants Needed

This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.

Trial Details

Trial Status:Recruiting
Sex:Female

110 Participants Needed

In the effort to reduce postoperative opioid use, there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process. Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery (ERAS) protocol and the use of peripheral and truncal nerve blocks. Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care. The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum (QL) nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy. Subjects will be randomized to the ERAS protocol or the QL block. The main questions the study aims to answer are: 1) does the QL block decrease patient reported pain scores postoperatively; and 2) does the QL block decrease the amount of opioid pain medications in the immediate postoperative period? The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit (PACU) following surgery.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

70 Participants Needed

The purpose of the study is to evaluate the surgical outcomes of injecting platelet-rich plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse surgery

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

60 Participants Needed

A novel vaginal orthosis, or splint, made of silicone will be used daily to help support the healing vaginal reconstruction during the post-operative phase from week 2 to week 12.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

30 Participants Needed

The goal of this clinical trial is to learn about how Urogynecology patients use Artificial Intelligence (AI) Chatbots like ChatGPT, and how it affects healthcare decision making. The main question\[s\] it aims to answer are: * How does the AI Chatbot affect participants' understanding of diagnoses and participant satisfaction with a urogynecology consultation? * How accurate is the chatbot-provided diagnosis and counseling information? Participants will be asked to use the ChatGPT chatbot and ask it questions about the main problem the participant is seeing the doctor for, and will also be asked to fill out some questionnaires. Researchers will compare using the Chatbot before the visit, after the visit, or not at all to see if the way participants understand the information changes based on timing of use.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Sex:Female

125 Participants Needed

The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress test (M2) for the prediction and prevention of PONSUI. The rates of PONSUI and its effect on patient reported outcomes and quality of life will be determined among women with positive or negative tests, and those with and without concomitant anti-incontinence procedure performed. This information will help inform larger studies on the topic.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

100 Participants Needed

Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. There are no studies regarding the use of TXA in urogynecology. The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery.

Trial Details

Trial Status:Not Yet Recruiting
Age:50 - 100
Sex:Female

36 Participants Needed

This trial compares two surgical methods, tunneling and dissection, used in robot-assisted surgery to fix a condition where pelvic organs drop from their normal position. It targets women with significant issues who need this surgery. The robot helps the surgeon perform the operation more accurately. The study aims to find out which method is better in terms of surgery time, recovery, and complications. Robot-assisted surgery for this condition has become increasingly popular due to its advantages in precision and ease of performing complex tasks compared to traditional methods.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

40 Participants Needed

The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery. Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female

118 Participants Needed

Why Other Patients Applied

"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."

IZ
Healthy Volunteer PatientAge: 38

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50

"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."

ID
Pancreatic Cancer PatientAge: 40

"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."

WR
Obesity PatientAge: 58

"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."

FF
ADHD PatientAge: 31
Pelvic organ prolapse (POP) is a common health issue. It will impact about half of Canadian women over their lifetime. With POP, organs like the bladder, uterus, and bowel may push into the vagina. Women may experience urine leakage, physical discomfort, and embarrassment. Aside from surgery, a common treatment for POP is the use of pessaries. Pessaries are removable devices placed inside the vagina that can relieve POP symptoms. Unfortunately, pessaries have fixed sizes and three in ten patients cannot find the right fit. Pessaries can cause bleeding and discomfort if they do not fit well or are not removed and cleaned regularly. Almost half of patients who wear pessaries stop using them because of these issues. There is a need for a better pessary treatment for patients. The investigators have developed a new pessary that has the natural shape of the vagina. This pessary is easier to remove and re-insert. The pessary is also custom fit for each patient. In this study, the investigators will compare our new pessary to traditional pessaries. Study participants who have been fit with a traditional pessary will be asked to use our new pessary design for 3 months. Study participants will fill out questionnaires about their POP symptoms. The investigators will also ask patients to provide their feedback on comfort and how easy it is to use the new pessary. This study could open up new possibilities for treating POP across Canada and around the world.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female

43 Participants Needed

This trial compares two surgeries for treating pelvic organ prolapse: one uses a robot to place a supportive mesh, and the other uses stitches to lift and secure the organs through the vagina. The goal is to find out which method is more effective.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

112 Participants Needed

This is a Canadian, multi-centre, double-blind randomized controlled trial of an innovative vaginal surgery technique for correction of pelvic organ prolapse (POP) in women. Vaginal surgery is preferred as minimally invasive, however the investigators do not know if materials such as synthetic polypropylene mesh improve success, durability and cost-effectiveness long-term. The investigators principal goal is to compare the experimental bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M) to the current standard of sacrospinous ligament suspension with synthetic sutures (SSLS) over a timeline of 2 years. Patients and evaluators will be blind to technique.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:19+
Sex:Female

358 Participants Needed

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Frequently Asked Questions

How much do Pelvic Organ Prolapse clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Pelvic Organ Prolapse clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Pelvic Organ Prolapse trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Pelvic Organ Prolapse is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Pelvic Organ Prolapse medical study?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Pelvic Organ Prolapse clinical trials?

Most recently, we added Personalizable Pessary for Pelvic Organ Prolapse, RP-MUS vs PAHG for Stress Incontinence and QL Block + ERAS Protocol for Postoperative Pain to the Power online platform.

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