Trial Outcomes & Findings for Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm (NCT NCT01859507)

Results Overview

The primary outcome will be assessed by the couple. The couple is allowed to visit for follow up in a 4 weeks' time. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completed without premature interruption from either partners.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Up to four weeks following the last session of the vaginal dilatation.

Results posted on

2015-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Botox Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus. Trade Name: BOTOX 100 units vial Injection of Botox in the perineal muscles in resistant cases of vaginismus
Overall Study STARTED	32
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Botox Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus. Trade Name: BOTOX 100 units vial Injection of Botox in the perineal muscles in resistant cases of vaginismus
Overall Study left the country	4

Baseline Characteristics

Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botox n=28 Participants Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus. Trade Name: BOTOX 100 units vial Injection of Botox in the perineal muscles in resistant cases of vaginismus
Age, Continuous	29.25 years STANDARD_DEVIATION 4.85 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Egypt	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to four weeks following the last session of the vaginal dilatation.

Population: multiple penetration with minimal pain as informed by the couple during their follow up sessions 4 weeks after the completion of the dilatation sessions

The primary outcome will be assessed by the couple. The couple is allowed to visit for follow up in a 4 weeks' time. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completed without premature interruption from either partners.

Outcome measures

Outcome measures
Measure	Botox n=28 Participants Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus. Trade Name: BOTOX 100 units vial Injection of Botox in the perineal muscles in resistant cases of vaginismus
Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain	28 participants

SECONDARY outcome

Timeframe: Within twelve months after the Botox injection

The level of comfort by the couple. The secondary outcome will be assessed by the couple. The couple is allowed to visit for follow up every three months for twelve months. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completedwithout premature interruption from either partners.

Outcome measures

Outcome measures
Measure	Botox n=28 Participants Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus. Trade Name: BOTOX 100 units vial Injection of Botox in the perineal muscles in resistant cases of vaginismus
Successful Sexual Relationship	28 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

Abdelmaguid Ramzy

Cairo University. Department of Obstetrics and Gynecology

Phone: +201008606060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place