Clinical Trials Logo
  1. Home
  2. Pelvic Pain
  3. NCT03199534

A Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction

Pelvic Pain Clinical Trial

Official title:
A Prospective Cohort Trial of Pelvic Floor Chemodenervation in Patients Undergoing Physical Therapy for High Tone Pelvic Floor Dysfunction

Clinical Trial Summary

This study assesses whether the addition of chemodenervation to an established regimen of pelvic floor physical therapy for painful high tone pelvic floor dysfunction improves patients' objective and subjective outcomes. Study subjects will select one of three treatment approaches: injection of 50 units Botulinum toxin A with local sedation as an office procedure, injection of 100u BoNTA-cosmetic in either the office or while anesthetized, or injection of 150 units Botulinum toxin A while anesthetized.

Clinical Trial Description

High-tone pelvic floor dysfunction is often a painful condition that can be associated with a number of female pelvic syndromes including childhood elimination disorders, idiopathic urinary retention, vaginismus, dyspareunia, pelvic pain, constipation, sport injuries, postoperative and bladder pain syndrome/interstitial cystitis. Following appropriate patient education about pelvic floor function, mainstays of therapy for high-tone pelvic floor dysfunction pelvic pain include pharmacotherapeutic agents and pelvic floor physical therapy. The investigators hypothesize that chemodenervation with Botulinum toxin A will offer a safe, efficacious intervention for women with high tone pelvic floor dysfunction that cannot be adequately treated with pelvic floor physical therapy alone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03199534
Study type Interventional
Source EvergreenHealth
Contact
Status Completed
Phase Phase 4
Start date May 25, 2017
Completion date February 26, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT03740932 - Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain
Completed NCT04077801 - Effect Of Chronic Pelvic Pain on Lumbopelvic Alignment And TemproMandibular Joint Kinematics in Women
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Recruiting NCT03868137 - Multi-dose Ibuprofen Prophylaxis for IUD-insertion N/A
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Completed NCT02547857 - Transvaginal Pelvic Ultrasound in the ED N/A
Completed NCT02923245 - POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound N/A
Completed NCT01938092 - Vaginal Diazepam for the Treatment of Female Pelvic Pain Phase 2
Active, not recruiting NCT01731470 - Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) N/A
Completed NCT01421641 - Tenaculum Pain Control Study Phase 4
Completed NCT00034047 - Endometriosis : Traditional Medicine vs Hormone Therapy Phase 1/Phase 2
Completed NCT05368155 - Chronic Pelvic Pain and Education Skills Training for Women Veterans N/A
Completed NCT04179149 - Enriched Environments in Endometriosis N/A
Not yet recruiting NCT05530681 - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth N/A
Completed NCT04077775 - Temporomandibular Joint Kinematics Changes in Pregnant Women: A Case-control Study
Completed NCT03715777 - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain Phase 3
Recruiting NCT05926752 - Photobiomodulation for Myofascial Pelvic Pain N/A
Completed NCT02588885 - Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention N/A
Completed NCT02261740 - Program to Overcome Pelvic Pain With Yoga N/A