Pelvic Pain Research: What’s Happening and Who’s Recruiting?


Pelvic pain research “nerd alert”.

You have been warned!

Here’s a sampling of some of the great research projects and trials (primarily pelvic pain with some others sprinkled in) listed as CURRENTLY recruiting subjects in the United States and Canada.  Who else hopes the funding dollars are there to support these (crossing fingers)!? Let’s face it: pelvic pain is complex and there’s still a lot to learn from research regarding how to treat these conditions with a multimodal approach.

This does not include all of the research going on worldwide…yet!  Please feel free to share (in the comments section) any other research trials. 

 

Google Image - Gary Larson comic

Google Image – Gary Larson comic

Pharmacology Trials

There are currently a few major studies recruiting patients from all over the United States:

Interstitial Cystitis / Bladder Pain (Multiple locations across the U.S.) This research study is designed to see how well an investigational study medicine works at reducing moderate-to-severe IC/BPS pain.This interstitial cystitis/bladder pain syndrome (IC/BPS) study is enrolling women 18 years and older with IC/BPS. Up to 150 women with IC/BPS across the United States will participate. 

Chronic Pelvic Pain  University of Maryland, Baltimore, Maryland. Patients are needed to participate in a clinical research study evaluating Duloxetine and Sugar Pill for the treatment of Pelvis Pain Chronic.

A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response  The Specific aims of this project are to (1) test the prediction that pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with gabapentin compared to when treated with placebo. Secondary outcome measures include intercourse pain and 24-hour pain and (2)perform a mechanism-based analysis of gabapentin effectiveness, and to gain insight into the underlying pathophysiology of subtypes of PVD that may lead to more specific treatment options.

*Pharmacology trials provide an opportunity for breakthroughs in finding new ways of managing complex pelvic health conditions. We hope that the pharmacology companies are ethical in their use of data and publish all outcomes. Here’s info on the controversy. 

Epidemiology, Phenotypes, Neural Pathways

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Multi-Disciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) **Excellent, collaborative research network. Recruiting link!

To help better understand the underlying causes of the two most prominent chronic urological pain syndromes—interstitial cystitis/painful bladder syndrome (IC/PBS) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)—the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH), has launched a new and novel research study.

The NIDDK’s Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network embraces a systemic—or whole-body—approach in the study of IC/PBS and CP/CPPS.

A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia (VV/IC)

In order to investigate whether the pain in women with vulvodynia may represent bladder origin pain, we will be performing a diagnostic test for interstitial cystitis (IC) in women with generalizedvulvodynia. Those women with a positive test for IC, we will be performing a series of bladder treatments (instillations) for IC and checking symptoms throughout the trial to see if significant relief of vulvar pain can be obtained through treatment for IC.

Prospective Data Bank Creation to Study Vaginal Conditions  The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development ofvulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.

Brain Imaging/ Mapping

Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest. (MMI)

UCLA study currently recruiting: The overall goal is to identify structural and functional brain abnormalities in patients with chronic pain conditions, such as Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD), Cyclical Vomiting Syndrome (CVs), Non Cardiac Chest Pain (NCCP) or Inflammatory Bowel Disease (IBD), and comparing those differences between conditions; and matched healthy control subjects.

Condition
Irritable Bowel Syndrome
Non Cardiac Chest Pain
Cyclical Vomiting Syndrome
Functional Dyspepsia
Gastroparesis
Ulcerative Colitis
Vulvodynia
Crohn’s Disease

Surgical Trials

Functional Status in Older Women Undergoing Surgery for Pelvic Organ Prolapse

(U. Penn) This prospective longitudinal observational study will assess the functional status of women over the age of 60 undergoing surgical treatment for pelvic organ prolapse. All women will complete questionnaires regarding functional status, co-morbidities, and frailty at a baseline visit. Surgery for pelvic organ prolapse will be performed by the treating surgeon. Women will then report for post-operative follow-up visits at 6 and 12 weeks following surgery. Questionnaires measuring functional status will be completed at these visits as well. Principle Investigator: Lily Arya, MD

*More in this section upcoming.

Behavioral Trials

Validation of Instruments for Pragmatic Clinical Trials for Overactive Bladder

(U. Penn) The purpose of the study is to assess your urinary symptoms, their impact on your quality of life, and the effect of treating these symptoms.  We also want to measure your willingness to stay on medication (adherence).  This study will last for 3 months past the screening visit.  Visits include screening (physical exam and urine testing); baseline visit (bladder diary; questionnaires; medication); 2 week follow-up phone call; 8 week follow-up visit (in office: bladder diary; questionnaires) and 3 month follow-up visit (identical to 8 wk. visit). Principal Investigator: Lily A. Arya, MD

For more information about our clinical trials in urogynecology, please call 215-662-7727 or send an email toreproresearch@obgyn.upenn.edu

Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia (COMFORT)

University of British Columbia (Currently Recruiting):  This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with provoked vestibulodynia (PVD).

Pelvic Physical Therapy / Manual Therapy

Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

University of British Columbia (Currently Recruiting):  This study will look at specific physiotherapy treatment interventions to see if they decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastophizing behaviour. Participants will fill out a questionnaire on their pain symptoms and complete standardized scales prior to starting treatment and after 4 sessions to determine change due to interventions.

Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

Université de Sherbrooke (Canada – Currently Recruiting): This study aims at better understanding and treating gynaecological pain. The focus of the study will be provoked vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva.

Neuromodulation

Refractory Overactive Bladder: Sacral Neuromudulation v. Botulinum Toxin Assessment (ROSETTA)

(U. Penn) The purpose of this randomized, open label, active-control trial is to compare the effectiveness of an experimental treatment, botulinum toxin A (BOTOX) versus standard of care sacral neuromodulation (INTERSTIM) for the treatment of urge urinary incontinence (UUI). This study will look at women with refractory and severe UUI i.e. women who have failed conservative management and have at least 6 episodes of UUI on the bladder diary.  Effectiveness data will be collected at 3, 6, 12, and 24 months after the intervention.Principal Investigator: Lily A. Arya, MD

For more information about our clinical trials in urogynecology, please call 215-662-7727 or send an email toreproresearch@obgyn.upenn.edu

Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome

Purpose:

  1. To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
  2. The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).

Additional Clinical Trials:

Interstitial Cystitis – Clinical Trials

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Endometriosis Clinical Trials across the U.S.  

 

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