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Trial record 1 of 2 for:    Pacik
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Botox Injection for Treatment of Vaginismus

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ClinicalTrials.gov Identifier: NCT01352546
Recruitment Status : Completed
First Posted : May 12, 2011
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Peter T. Pacik, MD, FACS, Plastic Surgery Professional Association

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vaginismus
Intervention Biological: BOTOX
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BOTOX
Hide Arm/Group Description

Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.

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

Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title BOTOX
Hide Arm/Group Description

Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.

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

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
27.3
(20 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
31
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Ability to Achieve Pain Free Intercourse.
Hide Description 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.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BOTOX
Hide Arm/Group Description:

Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.

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

Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
90.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BOTOX
Hide Arm/Group Description

Intravaginal (lateral aspects-bulbospongiosum) Botox injections, bupivacaine injections to the side walls of the vagina (cervix to introitus), progressive dilation under anesthesia and post procedure counseling and support to cure vaginismus.

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

All-Cause Mortality
BOTOX
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
BOTOX
Affected / at Risk (%)
Total   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BOTOX
Affected / at Risk (%)
Total   0/31 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter T. Pacik, MD, FACS
Organization: Plastic Surgery Professional Association
Phone: 603 387 7735
EMail: ptpacik@verizon.net
Publications of Results:
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
Layout table for additonal information
Responsible Party: Peter T. Pacik, MD, FACS, Plastic Surgery Professional Association
ClinicalTrials.gov Identifier: NCT01352546    
Other Study ID Numbers: BTX-PV-01
First Submitted: May 10, 2011
First Posted: May 12, 2011
Results First Submitted: August 1, 2017
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017