Botox Injection for Treatment of Vaginismus

NCT01352546 | Completed Phase 1 Results DMC

• 1 other identifier: BTX-PV-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The use of Botox injections intravaginally and progressive dilation under anesthesia has been shown to cure vaginismus. This study expands the use of Botox injections to include progressive dilation, post procedure supervised dilation and sex counseling to help women transition from dilators to intercourse. Since 2005 patients continue to experience a cure rate in excess of 90%. As of December 2012 more than 200 vaginismus patients have been treated this way. In this completed study of 30 patients with a minimum of one year follow-up 29 vaginismus patients were able to advance to pain free intercourse (97%) and one patient failed to achieve her goals presumably due to uncontrolled anxiety relating to vaginal penetration.

Conditions

Vaginismus

Keywords

vaginismus; painful sex; painful intercourse; dyspareunia; inability to have intercourse; inability to consummate marriage; vaginal spasm; "hitting a wall"; pain during sex; pain during intercourse; burning with intercourse

Outcome Measures

Primary Outcomes (1)

• Ability to Achieve Pain Free Intercourse.

  Patients need to be able to transition from the use of vaginal dilators to pain free intercourse, or to be able to continue using the #5 or #6 of 6 dilators in the absence of a partner.

  one year

Study Arms (1)

BOTOX

EXPERIMENTAL

intravaginal Botox injections and progressive dilation under anesthesia to cure vaginismus.

Biological: BOTOX

Interventions

BOTOX BIOLOGICAL

150 units of Botox injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia.

BOTOX

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-pregnant healthy females aged 20-40 with Lamont level 1-4 primary vaginismus.
• Willing to practice a reliable method of contraception for the first 4 months after treatment.
• Able to understand and comply with the requirements of the study and sign Informed Consent.

You may not qualify if:

• Female subjects who are pregnant (positive urine pregnancy test), trying to become pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
• Allergy or sensitivity to any component of the test medication
• History of poor cooperation, non-compliance with medical treatment, or unreliability.
• Intact hymen, dyspareunia, secondary vaginismus, vulvodynia, dermatopathology of the vulva or perineum, anal fissure, associated urinary or rectal problems, complex pain disorders of the urogenital diaphragm or pelvic floor including pudendal nerve entrapment, psychiatric illness.
• Treatment with botulinum toxin of any serotype prior to enrollment in study.
• Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
• Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition.
• Infection or skin disorder at an anticipated injection site.
• Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
• Participation in an investigational drug study within 30 days of the Baseline Visit.

Sponsors & Collaborators

• Plastic Surgery Professional Association: lead
• Allergan: collaborator

Study Sites (1)

Plastic Surgery Professional Association

Manchester, New Hampshire, 03104, United States

Location

Related Publications (6)

• Pacik PT. Botox treatment for vaginismus. Plast Reconstr Surg. 2009 Dec;124(6):455e-456e. doi: 10.1097/PRS.0b013e3181bf7f11. No abstract available.

  PMID: 19952618 BACKGROUND

• Pacik PT. Vaginismus: review of current concepts and treatment using botox injections, bupivacaine injections, and progressive dilation with the patient under anesthesia. Aesthetic Plast Surg. 2011 Dec;35(6):1160-4. doi: 10.1007/s00266-011-9737-5. Epub 2011 May 10.

  PMID: 21556985 BACKGROUND

• Pacik PT, Cole JB. When Sex Seems Impossible. Stories of Vaginismus & How You Can Achieve Intimacy. Odyne Publishing 2010

  BACKGROUND

• Pacik PT. Understanding and treating vaginismus: a multimodal approach. Int Urogynecol J. 2014 Dec;25(12):1613-20. doi: 10.1007/s00192-014-2421-y. Epub 2014 Jun 4.

  PMID: 24894201 BACKGROUND

• Pacik PT, Geletta S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med. 2017 Jun;5(2):e114-e123. doi: 10.1016/j.esxm.2017.02.002. Epub 2017 Mar 28.

  PMID: 28363809 RESULT

• Pacik, P. T. (2015), OnabotulinumtoxinA as Part of a Multimodal Program to Treat Vaginismus. Journal of Applied Biobehavioral Research, 20: 25-36. doi:10.1111/jabr.12037

  RESULT

MeSH Terms

Conditions

Vaginismus; Dyspareunia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Peter T. Pacik, MD, FACS
• Organization: Plastic Surgery Professional Association

ptpacik@verizon.net

603 387 7735

Study Officials

• Peter T Pacik, MD

  Plastic Surgery PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director Plastic Surgery Professional Association

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 12, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 7, 2017
• Results First Posted: August 7, 2017

Record last verified: 2017-08

Locations

US (1)