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Effect of physiotherapy and botulinum toxin injection in treatment of vaginismus

Evaluation of therapeutic efficacy of physiotherapy and botulinum toxin injection in treatment of vaginismus and comparison of sexual function of them

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016061828486N1
Enrollment
74
Registered
2017-03-12
Start date
2017-02-08
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychogenic vaginismus. Spasm of the pelvic floor muscles that surround the vagina, causing occlusion of the vaginal opening. Penile entry is either impossible or painful

Interventions

Intervention 1: intervention group 1:injection of botulinum toxin (dysport ):500 unit is diluted in 1.5 cc N/S.150-400 U disport was equally injected in the puborectalis muscles ,3 points on each side
Treatment - Drugs
Rehabilitation
intervention group 1:injection of botulinum toxin (dysport ):500 unit is diluted in 1.5 cc N/S.150-400 U disport was equally injected in the puborectalis muscles ,3 points on each side with 23 needle.
Control group:Physiotherapy: relaxation exercises, biofeedback, desensitization and focus sensory (sensation focus) is used during weekly meetings.Patients initially trained in pelvic floor anatomy .

Sponsors

Vice Chancellor for research of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: inclusion criteria:20-40 years old nonpregnant women of sexual health and women clinics of emem khomeini hospital which have grade 3 or 4 vaginismus on lamont grading; they dont have any botulinum toxin containdication( albumin and botulinum or injectable component alergy; infection of injection site; pregnancy; nerve and muscle desease such as Myasthenia Gravis and Lambert Eaton syndrome; coagulation disorders; anticoagulant drugs exclusion criteria:pregnant women; pregnancy planing; botulinum contraindication; poor cooperation; secondary vaginismus; Vvlvdynya; skin disorders of vulve or Perineum; anal fissure; urinary or deficatory disorders; infection of injection site; previous botulinum treatment; previous physiotherapy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Libido. Timepoint: before and 1week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).;Arousal. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).;Lubrication. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).;Orgasm. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).;Sexual Satisfaction. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).;Pain. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTahereh Eftekhar dr

Tehran University Of Medical sciences

eftekhart@sina.tums.ac.ir+98 21 6643 8633

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 4, 2026