Trial Outcomes & Findings for Botox Injection for Treatment of Vaginismus (NCT NCT01352546)
NCT ID: NCT01352546
Last Updated: 2017-08-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
one year
Results posted on
2017-08-07
Participant Flow
Participant milestones
| Measure |
BOTOX
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 Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Botox Injection for Treatment of Vaginismus
Baseline characteristics by cohort
| Measure |
BOTOX
n=31 Participants
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.
|
|---|---|
|
Age, Continuous
|
27.3 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: one yearPatients 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.
Outcome measures
| Measure |
BOTOX
n=31 Participants
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.
|
|---|---|
|
Ability to Achieve Pain Free Intercourse.
|
90.3 percentage of participants
|
Adverse Events
BOTOX
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Peter T. Pacik, MD, FACS
Plastic Surgery Professional Association
Phone: 603 387 7735
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place