Female Sexual Dysfunction Assessment and Managment of Vaginismus

NCT06755099 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Treatment trials in vaginismus
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims at :

1. 1.The extent female sexual dysfunction problem in community through questionnaire .
2. 2.Compare effectiveness of two treatment options for vaginismus .

Conditions

Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (2)

• - prevalence of female sexual dysfunction and vaginal penetration pain disorders - prevalence of female sexual dysfunction and vaginal penetration pain disorders.

  1 year

• Reevaluate female sexual function index score after intervention

  6 months after intervention

Study Arms (2)

botox injection arm

EXPERIMENTAL

patients in this group will be treated by Botox injection

Drug: Botox

radio frequency arm

EXPERIMENTAL

patients in this group will be treated by radio frequency

Device: Radiofrequency

Interventions

Botox DRUG

The patient will be placed in gynecological position. Subsequently, the patient will be anesthetized with propofol bolus, a total of 270 mg IV sterilization of valval area with antiseptic solution then digital examination to assess the spasm of intriotus and vaginal walls under lowest possible doses then increasing the doses to allow for intra vaginal injection of Botox under full sedation. Pacik technique will be adopted for Botox Injection in the vagina . . One vial of frozen Botox 100 U will be diluted with 2 mL saline, without foaming or shaking the vial, giving a concentration of 2.5 U/0.05 mL . Using a small sized speculum and after bending the needle to 30° to facilitate injection into sub mucosal area,1 mL (50 U) of Botox will be injected into the right bulbocavernosus then into the left side .

botox injection arm

Radiofrequency DEVICE

Patients will be placed in prone position. After proper disinfection, the ischial spine (IS) and insertion point of the sacrospinous ligament will be identified using fluoroscopy medial to IS. 5 ml Lidocaine 2 % will be used to apply local anesthesia to the skin at the expected entry point for the radiofrequency cannula. Then a 20 G, 10 cm long and 1 cm active tip radiofrequency cannula will be introduced gradually utilizing 2 Hz motor stimulation until pudendal nerve is identified visually by the occurrence of contraction of the external anal sphincter muscle. Subsequently, pulsed radiofrequency lesioning at temperature limit of 42 C will be applied bilaterally to the pudendal nerves for 240 s (2 cycles of 120 s) after applying local anesthesia using 2 cm 2% lidocaine in its vicinity.

radio frequency arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 18to 40 years.
• Women diagnosed with primary vaginismus.
• Vaginismus has been classified by Lamont (12) according to its severity into four degrees or grades:
• In first degree (also known as grade 1 vaginismus), the patient has spasm of the pelvic floor that can be relieved with reassurance.
• In the second degree, the spasm is present throughout the pelvis even with reassurance.
• In third degree, the patient elevates her buttocks to avoid being examined.
• In fourth degree vaginismus, the most severe form of vaginismus, the patient elevates the buttocks, retreats, and tightly closes her thighs to avoid examination

You may not qualify if:

• Refusing to participate in the study
• Women whose husbands have an erectile dysfunction.
• women with secondary vaginismus.
• Women with psychiatric disorders.
• Lacking the appropriate cooperation for treatment and follow-up procedure.
• Having any contraindications to receiving botulinum, including allergies to albumin, botulinum toxin, or its injection components.
• Previous history of treatment with botulinum or physiotherapy.
• Infection at the injection site.
• Diseases involving nerves and muscles, such as myasthenia gravis and Lambert-Eaton syndrome, vulvodynia, cutaneous problems at the vulva or perineum, anal fissure, urinary duct or rectum disorders, and coagulation disorders urging them to use anticoagulation drugs

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

women's health hospital of Assiut University

Asyut, Egypt

Location

Related Publications (8)

• Ferreira JR, Souza RP. Botulinum toxin for vaginismus treatment. Pharmacology. 2012;89(5-6):256-9. doi: 10.1159/000337383.

  PMID: 22507920 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 BACKGROUND

• Matak I, Bolcskei K, Bach-Rojecky L, Helyes Z. Mechanisms of Botulinum Toxin Type A Action on Pain. Toxins (Basel). 2019 Aug 5;11(8):459. doi: 10.3390/toxins11080459.

  PMID: 31387301 BACKGROUND

• Stachowicz AM, Hoover ML, Karram MM. Clinical utility of radiofrequency energy for female genitourinary dysfunction: past, present, and future. Int Urogynecol J. 2021 Jun;32(6):1345-1350. doi: 10.1007/s00192-021-04735-9. Epub 2021 Mar 4.

  PMID: 33661319 BACKGROUND

• Juhasz MLW, Korta DZ, Mesinkovska NA. Vaginal Rejuvenation: A Retrospective Review of Lasers and Radiofrequency Devices. Dermatol Surg. 2021 Apr 1;47(4):489-494. doi: 10.1097/DSS.0000000000002845.

  PMID: 33165070 BACKGROUND

• Banaei M, Kariman N, Ozgoli G, Nasiri M. Bio-psychosocial factor of vaginismus in Iranian women. Reprod Health. 2021 Oct 18;18(1):210. doi: 10.1186/s12978-021-01260-2.

  PMID: 34663378 BACKGROUND

• Fadul R, Garcia R, Zapata-Boluda R, Aranda-Pastor C, Brotto L, Parron-Carreno T, Alarcon-Rodriguez R. Psychosocial Correlates of Vaginismus Diagnosis: A Case-Control Study. J Sex Marital Ther. 2019;45(1):73-83. doi: 10.1080/0092623X.2018.1484401. Epub 2019 Feb 7.

  PMID: 30044690 BACKGROUND

• McCool-Myers M, Theurich M, Zuelke A, Knuettel H, Apfelbacher C. Predictors of female sexual dysfunction: a systematic review and qualitative analysis through gender inequality paradigms. BMC Womens Health. 2018 Jun 22;18(1):108. doi: 10.1186/s12905-018-0602-4.

  PMID: 29929499 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A

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

Central Study Contacts

Doaa Mostafa Mahmoud

CONTACT

+0201061699727; doaa21122@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 1, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR

Locations

EG (1)